Mesalazine    (DrugBank: Mesalazine)

3 diseases
IDDisease name (Link within this page)Number of trials
46Malignant rheumatoid arthritis1
96Crohn disease28
97Ulcerative colitis209

46. Malignant rheumatoid arthritis    [ 4,183 clinical trials,   2,538 drugs,   (DrugBank: 401 drugs),   183 drug target genes,   219 drug target pathways]
Searched query = "Malignant rheumatoid arthritis", "Rheumatoid arthritis", "Rheumatoid arthritis with vasculitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 4,183 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000005362
2011/04/0101/04/2011Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by non-steroidal anti-inflammatory drugs(NSAIDs). Patients with rheumatoid arthritis with anemia taking NSAIDsTreatment with mesalazineDepartment of Gastroenterology and Hepatology, Osaka University Graduate School of MedicineNULLComplete: follow-up complete20years-old70years-oldMale and Female13Not selectedJapan

96. Crohn disease    [ 2,209 clinical trials,   1,276 drugs,   (DrugBank: 240 drugs),   166 drug target genes,   210 drug target pathways]
Searched query = "Crohn disease", "Terminal ileitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
28 / 2,209 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-001382-17-GB
(EUCTR)
30/10/201824/06/2019An investigational study to assess the safety and effectiveness of continuing existing 5-ASA medication versus stopping it.Stopping Aminosalicylate Therapy in Inactive Crohn’s Disease (STATIC) Study: A Randomized, Open-label, Non-inferiority Trial - STATIC Inactive Crohn’s Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]INN or Proposed INN: MESALAZINEAlimentiv IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1580Phase 4Canada;United Kingdom
2NCT02769494
(ClinicalTrials.gov)
March 20169/3/2016The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral UlcerThe Efficacy of Topically Applied Mesalazine Sustained-Release Tablets in Oral Lesions of Crohn's DiseaseCrohn's Disease;Oral UlcerDrug: Mesalazine Sustained-Release Tablets;Drug: Riboflavin Sodium Phosphate InjectionXijing Hospital of Digestive DiseasesNULLRecruiting18 Years65 YearsBoth40Phase 3China
3NCT02335281
(ClinicalTrials.gov)
January 20157/1/2015Standardized Fecal Microbiota Transplantation for Inflammatory Bowel DiseaseEfficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation for Severe Inflammatory Bowel DiseaseInflammatory Bowel Disease;Ulcerative Colitis;Crohn's DiseaseProcedure: FMT;Drug: MesalazineYanling WeiNULLRecruiting16 Years70 YearsBoth40Phase 2China
4NCT02044952
(ClinicalTrials.gov)
January 201419/1/2014Efficacy and Safety Study of Tripterygium Glycoside in the Treatment of Crohn's Disease for Induction RemissionProspective Experimental of Tripterygium Glycoside in the Treatment of Crohn's Disease for Induction RemissionInflammatory Bowel Diseases;Crohn's Disease;Gastrointestinal Diseases;Digestive System Diseases;Intestinal DiseasesDrug: Mesalazine, Tripterygium glycosidesZhu WeimingNULLRecruiting18 Years75 YearsBoth40Phase 2;Phase 3China
5NCT01514240
(ClinicalTrials.gov)
February 201210/1/2012Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in JapanA Multicentre, Double-blind, Randomised, Parallel-group, Phase III Study to Assess Efficacy and Safety of D9421-C 9 mg Versus Mesalazine 3 g in Patients With Active Crohn's Disease (CD) in JapanCrohn's DiseaseDrug: D9421-C capsule 3 mg;Drug: Mesalazine tabletsAstraZenecaNULLCompleted15 Years130 YearsAll123Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2009-011220-62-NL
(EUCTR)
26/10/200913/07/2009A randomized controlled withdrawal trial in Crohn's disease patients in long-term remission on mesalazine: the CROWN studyA randomized controlled withdrawal trial in Crohn's disease patients in long-term remission on mesalazine: the CROWN study 1. Patients with a diagnosis of quiscent (CDAI < 150) Crohn's Disease (CD) according to established clinical, endoscopic, radiological and histological criteria. 2. Patients will be aged 18 years or older. 3. Patients with mesalazine maintenance therapy > 1 year.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: mesalazine
INN or Proposed INN: mesalazine
Other descriptive name: AMINOSALICYLIC ACID
University Medical Center UtrechtNULLNot RecruitingFemale: yes
Male: yes
Netherlands
7NCT00862121
(ClinicalTrials.gov)
April 200913/3/2009A Study With Pentasa in Patients With Active Crohn's DiseasePENTASA in Active Crohn's Disease: A 10-week, Double-blind, Multi-centre Trial Comparing PENTASA Sachet 6 g/Day (Mesalazine, Mesalamine) With Placebo.Crohn´s DiseaseDrug: Pentasa;Drug: PlaceboFerring PharmaceuticalsNULLTerminated18 YearsN/AAll20Phase 3United States;Belgium;Denmark;France;Germany;Sweden;United Kingdom;Spain
8NCT00245505
(ClinicalTrials.gov)
February 200926/10/2005The Effect on Mucosal Healing With Pentasa Sachet in Mild to Moderate Active Drug: Crohn's DiseaseThe Effect on Mucosal Healing With Pentasa Sachet 4g in Mild to Moderate Active Small Bowel Crohn´s Disease, Evaluated by Video Capsule Endoscopy After 6 and 12 Weeks Treatment. A Pilot StudyCrohn's DiseaseDrug: Mesalazine (Mesalamine)Ferring PharmaceuticalsNULLTerminated18 Years70 YearsBoth3Phase 3Sweden
9EUCTR2008-002100-26-BE
(EUCTR)
28/01/200931/07/2008PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACEPENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid
Ferring Pharmaceuticals A/SNULLNot RecruitingFemale: yes
Male: yes
510France;Belgium;Denmark;Germany;United Kingdom;Sweden
10EUCTR2008-002100-26-FR
(EUCTR)
16/01/200902/09/2008PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placeboPENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid
Ferring Pharmaceuticals A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
510Germany;United Kingdom;Denmark;Belgium;France;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2008-002100-26-GB
(EUCTR)
07/01/200919/08/2008PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACEPENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid
Ferring Pharmaceuticals A/SNULLNot RecruitingFemale: yes
Male: yes
510Germany;United Kingdom;Denmark;Belgium;France;Sweden
12EUCTR2008-002100-26-SE
(EUCTR)
27/11/200808/08/2008PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACEPENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid
Ferring Pharmaceuticals A/SNULLNot RecruitingFemale: yes
Male: yes
510Germany;United Kingdom;Denmark;Belgium;France;Sweden
13EUCTR2008-002100-26-DE
(EUCTR)
19/11/200806/03/2009PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACEPENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid
Ferring Pharmaceuticals A/SNULLNot RecruitingFemale: yes
Male: yes
510France;Belgium;Denmark;Germany;United Kingdom;Sweden
14EUCTR2008-002100-26-DK
(EUCTR)
04/11/200818/08/2008PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACEPENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid
Ferring Pharmaceuticals A/SNULLNot RecruitingFemale: yes
Male: yes
510Germany;United Kingdom;Belgium;Denmark;France;Sweden
15EUCTR2004-001213-34-GB
(EUCTR)
30/01/200719/08/2008Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CDDouble-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD moderately active Crohn’s disease (200 < CDAI < 400)
MedDRA version: 7.0;Level: PT;Classification code 10011401
Trade Name: Salofalk
INN or Proposed INN: mesalazine
Other descriptive name: 5-Aminosalicyl acid
Trade Name: Budenofalk
INN or Proposed INN: budesonide
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
370Czech Republic;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16JPRN-C000000300
2005/12/0122/12/2005Z-206 Phase III Clinical Trial- Investigation on the remission-inducing effect in patients with Crohn's disease in active phase - Patients with Crohn's disease in active phaseZ-206 group:Three tablets of Z-206 400mg tablet, 4 tablets of Pentasa
placebo tablet per time (total 7 tablets).
3 times a day (t.i.d.) after each meal for 12 weeks.
Mesalazine group:Four tablets of Pentasa 250mg tablet, 3 tablets of Z-206 placebo tablet per time (total 7 tablets).
3 times a day (t.i.d.) after each meal for 12 weeks.
Placebo group:Three tablets of Z-206 placebo tablet, 4 tablets of Pentasa
placebo tablet per time (total 7 tablets).
3 times a day (t.i.d.) after each meal for 12 weeks.
Zeria Pharmaceutical Co.,LTDNULLComplete: follow-up complete16years-old64years-oldMale and Female60Phase 3Japan
17JPRN-C000000301
2005/12/0122/12/2005Z-206 Phase III Clinical Trial-Investigation on the remission–maintaining effect in patients with Crohn's disease in remission phase- Patients with Crohn's disease in remission phaseZ-206 group:Three tablets of Z-206 400mg tablet, 4 tablets of Pentasa
placebo tablet per time (total 7 tablets).
3 times a day (t.i.d.) after each meal for 48 weeks.
Mesalazine group:Four tablets of Pentasa 250mg tablet, 3 tablets of Z-206 placebo tablet per time (total 7 tablets).
3 times a day (t.i.d.) after each meal for 48 weeks.
Zeria Pharmaceutical Co.,LTD.NULLComplete: follow-up complete16years-old64years-oldMale and Female40Phase 2;Phase 3Japan
18EUCTR2005-002472-15-SE
(EUCTR)
22/09/200523/06/2005The effect on mucosal healing with Pentasa® Sachet 4 g in mild to moderate active small bowel Crohn's disease, evaluated with video capsule endoscopy after 6 and 12 weeks treatment. A pilot study. - N.A.The effect on mucosal healing with Pentasa® Sachet 4 g in mild to moderate active small bowel Crohn's disease, evaluated with video capsule endoscopy after 6 and 12 weeks treatment. A pilot study. - N.A. Mild to moderate active Crohn's disease
MedDRA version: 7.1;Level: PT;Classification code 10011401
Trade Name: Pentasa Sachet 1 g prolonged release granules
Product Name: Pentasa Sachet 1 g
INN or Proposed INN: mesalazine
Other descriptive name: 5-Aminosalicylic acid
Ferring Laegemidler A/SNULLNot RecruitingFemale: yes
Male: yes
10Sweden
19EUCTR2004-004083-77-SK
(EUCTR)
29/06/200531/01/2005A Randomised, International, Multicenter Study to assess the Efficacy and Safety of Mesalazine EC tablets 500 mg (4.5g/daily) and Salofalk® tablets 500 mg (4.5 g/daily) in the Treatment of Moderate Active Crohn diseaseA Randomised, International, Multicenter Study to assess the Efficacy and Safety of Mesalazine EC tablets 500 mg (4.5g/daily) and Salofalk® tablets 500 mg (4.5 g/daily) in the Treatment of Moderate Active Crohn disease Moderate active Crohn diseaseTrade Name: Mesalazine EC 500 mg
Product Name: Mesalazine EC 500 mg
INN or Proposed INN: mesalazine
Trade Name: Salofalk 500 mg
Product Name: Salofalk 500 mg
INN or Proposed INN: mesalazine
Disphar International B.V.NULLNot RecruitingFemale: yes
Male: yes
436Phase 3Czech Republic;Slovakia
20EUCTR2004-001213-34-SK
(EUCTR)
16/12/200416/08/2005Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CDDouble-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD moderately active Crohn’s disease (200 < CDAI < 400)
MedDRA version: 7.0;Level: PT;Classification code 10011401
INN or Proposed INN: mesalazine
INN or Proposed INN: budesonide
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
370Phase 3Czech Republic;Slovakia;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2004-004083-77-CZ
(EUCTR)
13/12/200402/12/2004A Randomised, International, Multicenter Study to assess the Efficacy and Safety of Mesalazine EC tablets 500 mg (4.5g/daily) and Salofalk® tablets 500 mg (4.5 g/daily) in the Treatment of Moderate Active Crohn diseaseA Randomised, International, Multicenter Study to assess the Efficacy and Safety of Mesalazine EC tablets 500 mg (4.5g/daily) and Salofalk® tablets 500 mg (4.5 g/daily) in the Treatment of Moderate Active Crohn disease Moderate active Crohn diseaseProduct Name: Mesalazine EC 500 mg
INN or Proposed INN: mesalazine
Product Name: Salofalk 500 mg
INN or Proposed INN: mesalazine
Disphar International B.V.NULLNot RecruitingFemale: yes
Male: yes
436Czech Republic
22EUCTR2004-001213-34-CZ
(EUCTR)
02/11/200402/11/2004Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CDDouble-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD moderately active Crohn’s disease (200 < CDAI < 400)
MedDRA version: 7.0;Level: PT;Classification code 10011401
INN or Proposed INN: mesalazine
INN or Proposed INN: budesonide
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
370United Kingdom;Czech Republic
23NCT00300118
(ClinicalTrials.gov)
September 20047/3/2006Oral Budesonide vs. Oral Mesalazine in Active Crohn's Disease (CD)Double-blind, Double-dummy, Randomized, Multicentre Study to Compare the Efficacy and Safety of Oral Budesonide (9 mg) and Oral Mesalazine (4.5 g) in Moderately Active Crohn's Disease PatientsCrohn's DiseaseDrug: budesonide;Drug: mesalazineDr. Falk Pharma GmbHNULLCompleted18 Years70 YearsBoth311Phase 3Germany
24NCT00976690
(ClinicalTrials.gov)
October 200211/9/2009Comparison Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn DiseaseA Multicentre Randomized Open Study Comparing Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn DiseaseCrohn DiseaseDrug: Azathioprine OR MesalazineGroupe d'Etude Therapeutique des Affections Inflammatoires DigestivesNULLCompleted18 YearsN/ABoth83Phase 3France
25NCT00946946
(ClinicalTrials.gov)
February 200224/7/2009Preventing Postoperative Relapse in Crohn's Disease Patients at Risk: Azathioprine Versus MesalazineDouble-blind, Double-dummy, Randomised, Multicentre, Comparative Study on the Efficacy and Safety of Azathioprine Versus Mesalazine for Prevention of Clinical Relapses in Crohn's Disease Patients With Postoperative Moderate or Severe Endoscopic RecurrenceCrohn's DiseaseDrug: Azathioprine;Drug: Mesalazine;Drug: Azathioprine placebo;Drug: Mesalazine placeboDr. Falk Pharma GmbHNULLCompleted18 Years70 YearsBoth78Phase 3Austria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26JPRN-JapicCTI-111460
29/03/2011Phase II Study of Z-206 in Patients with Active Crohn's DiseasePhase II Study of Z-206 in Patients with Active Crohn's Disease Active Crohn's diseaseIntervention name : Z-206
INN of the intervention : Mesalazine
Dosage And administration of the intervention : oral
Zeria Pharmaceutical Co., Ltd.Kyowa Hakko Kirin Co., Ltd.1664BOTHPhase 2NULL
27JPRN-JapicCTI-121765
A Multicentre, Double-blind, Randomised, Parallel-group, Phase3 Study to Assess Efficacy and Safety of D9421-C 9mg Versus Mesalazine 3g in Patients With Active Crohn's Disease (CD) in JapanA Multicentre, Double-blind, Randomised, Parallel-group, Phase3 Study to Assess Efficacy and Safety of D9421-C 9mg Versus Mesalazine 3g in Patients With Active Crohn's Disease (CD) in Japan Crohn's DiseaseIntervention name : D9421-C
Dosage And administration of the intervention : 9mg, Oral once daily
Control intervention name : Mesalazine
Dosage And administration of the control intervention : 1g, Oral three times a day
AstraZenecaNULL15BOTHPhase 3NULL
28EUCTR2014-004132-20-Outside-EU/EEA
(EUCTR)
28/07/2016Phase III study to assess efficacy and safety of D9421-C 9 mg with active Crohn’s Disease in JapanA multicentre, double-blind, randomised, parallel-group, Phase III study to assess efficacy and safety of D9421-C 9 mg versus Mesalazine 3 g in patients with active Crohn’s Disease in Japan Active Crohn’s Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Entocort
Product Code: D9421-C
INN or Proposed INN: budesonide
Trade Name: Pentasa
INN or Proposed INN: mesalazine
AstraZeneca K.K.NULLNAFemale: yes
Male: yes
112Phase 3Japan

97. Ulcerative colitis    [ 2,269 clinical trials,   1,331 drugs,   (DrugBank: 241 drugs),   114 drug target genes,   181 drug target pathways]
Searched query = "Ulcerative colitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
209 / 2,269 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2000038888
2020-10-192020-10-09Effect of Kangfuxin Liquid enema combined with mesalazine on gestational outcomes and quality of life in child -bearing female with active ulcerative colitis: a randomized, double-blind, controlled trialA systematic study on the criteria of syndrome differentiation of kidney yang deficiency in infertility Ulcerative colitiscontrol group:Mesalazine enteric-coated tablets + placebo enema;experimental group:Mesalazine enteric-coated tablets +Kangfuxin Liquid enema;Chengdu University of Traditional Chinese MedicineNULLRecruiting2045Femalecontrol group:118;experimental group:118;China
2ChiCTR2000035497
2020-10-012020-08-13A multicenter, randomized, controlled trial of Qingyu Powder in the treatment of mild to moderate active ulcerative colitisA multicenter, randomized, controlled trial of Qingyu Powder in the treatment of mild to moderate active ulcerative colitis ulcerative colitisExperimental group:Qingyusan;Control group:Mesalazine;Shuguang Hospital affiliated to Shanghai University of traditional Chinese MedicineNULLPendingBothExperimental group:40;Control group:40;China
3ChiCTR2000037220
2020-10-012020-08-27A randomized controlled clinical trial of Qingdai(indigo naturalis) in the treatment of mild to moderate active ulcerative colitisA randomized controlled clinical trial of Qingdai(indigo naturalis) in the treatment of mild to moderate active ulcerative colitis ulcerative colitisTraditional Chinese medicine group:Qingdai (indigo naturalis);Western medicine group:Mesalazine granules;Shuguang Hospital affiliated to Shanghai University of traditional Chinese MedicineNULLRecruitingBothTraditional Chinese medicine group:40;Western medicine group:40;China
4ChiCTR2000036950
2020-10-012020-08-25Study of Jianpi Huashi Decoction and Mesalazine on Ulcerative Colitis Patients with Spleen Deficiency and Damp-Heat TypeStudy of Jianpi Huashi Decoction and Mesalazine on Ulcerative Colitis Patients with Spleen Deficiency and Damp-Heat Type Uicerative colitisJianpi Huashi Decoction Group:Jianpi Huashi Decoction;Mesalazine Group:Mesalazine;Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of TCMNULLRecruitingBothJianpi Huashi Decoction Group:45;Mesalazine Group:45;China
5ChiCTR2000035099
2020-08-012020-07-31Study on TCM accurate syndrome differentiation and treatment scheme of ulcerative colitis based on intestinal microecology and multi-omics technologyStudy on TCM accurate syndrome differentiation and treatment scheme of ulcerative colitis based on intestinal microecology and multi-omics technology Uicerative colitisulcerative colitis damp-heat syndrome group:nil;ulcerative colitis qi deficiency syndrome group:nil;healthy control group:nil;damp-heat syndrome treatment group:Modified Gegenqinlian Decoction and Mesalazine;damp-heat syndrome control group:Mesalazine;qi deficiency syndrome treatment group:Modified Shenling Baizhu Powder and Mesalazine;qi deficiency syndrome control group:Mesalazine;Jiangsu Province Hospital of Chinese MedicineNULLRecruiting1865Bothulcerative colitis damp-heat syndrome group:30;ulcerative colitis qi deficiency syndrome group:30;healthy control group:30;damp-heat syndrome treatment group:60;damp-heat syndrome control group:30;qi deficiency syndrome treatment group:60;qi deficiency sChina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2019-003334-16-DE
(EUCTR)
26/06/202005/05/2020Novel budenosid suppository in addition to basic therapy with oral mesalazine compared to basic therapy alone for treatment of ulcerative colitisRandomised, double-blind, placebo-controlled, multicentre study to compare the efficacy and safety of novel 4 mg budesonide suppository in combination with oral mesalazine versus oral mesalazine monotherapy in patients with acute ulcerative colitis acute ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budenofalk® suppositories
INN or Proposed INN: BUDESONIDE
Other descriptive name: Budenofalk® suppositories (BUS)
Trade Name: Salofalk 3g gastro-resistant prolonged-release granules
Product Name: Salofalk 3g gastro-resistant prolonged-release granules
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3Belarus;Poland;Ukraine;Russian Federation;Bulgaria;Latvia;Germany
7ChiCTR2000028767
2020-04-272020-01-03A randomized, controlled trial for evaluating the efficacy and safety of oseltamivir in the treatment of ulcerative colitisA randomized, controlled trial for evaluating the efficacy and safety of oseltamivir in the treatment of ulcerative colitis ulcerative colitisExperimental group:Oseltamivir and mesalazine;Control group:mesalazine;Xiangya Hospital of Central South UniversityNULLRecruiting1875BothExperimental group:53;Control group:53;N/AChina
8ChiCTR2000028869
2020-01-032020-01-05phase IIa clinical trial of Colitis SuppositoriesA multicenter, randomized, blinded management, positive-drug parallel-controlled, preliminary exploratory phase IIa clinical trial on the efficacy and safety of Colitis Suppositories in the treatment for mild-to-moderate active ulcerative colitis (Qi-Deficiency and Blood-Stasis Syndrome), compared with the Mesalazine Suppositories (Salofalk) mild-to-moderate active ulcerative colitis (Qi-Deficiency and Blood-Stasis Syndrome)Experimental group:Colitis Suppositories, one at a time, twice a day, in the early and late anal plug into the rectum.;The control group:Mesalazine Suppositories, one at a time, twice a day, in the early and late anal plug into the rectum.;Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical UniversityNULLRecruiting1865BothExperimental group:30;The control group:30;Phase 2China
9ChiCTR1900025900
2019-12-012019-09-13Efficacy of Herbal enema prescriptionII(DHEP II) in the treatment of mild or moderate active symptoms of ulcerative colitis:A multicenter prospective randomized control clinical trial.Efficacy of Herbal enema prescriptionII(DHEP II) in the treatment of mild or moderate active symptoms of ulcerative colitis:A multicenter prospective randomized control clinical trial. Ulcerative colitisExperimental group:Mesalazine+DHEP II;control group:Mesalazine+Compound Huangbai lotion;Nanjing Hospital of Chinese MedicineNULLPendingBothExperimental group:200;control group:100;Phase 3China
10NCT04133194
(ClinicalTrials.gov)
November 28, 201910/10/2019Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative ColitisAdherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis (EASI-trial)Ulcerative ColitisDrug: MesalazineCopenhagen University Hospital, HvidovreNULLRecruiting18 Years60 YearsAll200Phase 4Denmark
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2019-002070-31-DK
(EUCTR)
05/09/201924/06/2019Compliance to treatment with new single-pill 5-ASA for patients with Ulcerative Colitis (EASI-trial)Adherence of a 1.600 mg single tablet 5-ASA treatment of Ulcerative colitis (EASI-trial) Ulcerative colitis (UC) belongs to the group of inflammatory bowel diseases. The disease course is unpredictable and characterised by chronic inflammation of the colonic mucosa, where acute attacks are followed by periods of remission. Development of UC is characterized by a dysregulated immune response and barrier dysfunction caused by genetic susceptibility and environmental triggers. UC only involves the colon, starting in the rectum and extending to proximal segments of the colon.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Asacol®
INN or Proposed INN: MESALAZINE
Copenhagen University Hospital HvidovreNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 4Denmark
12ChiCTR1900024086
2019-08-012019-06-24Modified Chinese Medicine Granule in the Treatment of Ulcerative Colitis in the Remission Phase: Study Protocol for a Series of N-of-1 Randomized, Double-Blind, Controlled TrialsModified Chinese Medicine Granule in the Treatment of Ulcerative Colitis in the Remission Phase: Study Protocol for a Series of N-of-1 Randomized, Double-Blind, Controlled Trials Ulcerative Colitisintervention period:Modified Chinese Medicine Granule and Mesalazine placebo;control period:Mesalazine and Modified Chinese Medicine Granule placebo;The First Affiliated Hospital of Guangzhou University of Chinese MedicineNULLPending1875Bothintervention period:10;control period:10;N/AChina
13ChiCTR1900024591
2019-07-222019-07-18Clinical evaluation for traditional Chinese medicine in the treatment of severe active ulcerative colitisClinical evaluation for traditional Chinese medicine in the treatment of severe active ulcerative colitis Ulcerative colitisTCM Group:Prednisone+New Wumeiwan Formula;Convenience medicine Group:Prednisone+Mesalazine Enteric-coated tablets (Salofalk);Combined Group:Prednisone+New Wumeiwan Formula+Mesalazine Enteric-coated tablets(Salofalk);Peking University First HospitalNULLPending1865BothTCM Group:40;Convenience medicine Group:40;Combined Group:40;China
14ChiCTR1900023158
2019-05-202019-05-14Clinical evaluation of traditional Chinese medicine on mild active ulcerative colitis: a multi-center, randomized, double-blind, controlled trialClinical evaluation of traditional Chinese medicine on mild active ulcerative colitis: a multi-center, randomized, double-blind, controlled trial Ulcerative colitisTCM Group:Hudi Enteric-coated Capsules+Mesalazine Enteric-coated Tablets(Salofalk)Simulator;Medical Group:Mesalazine Enteric-coated Tablets(Salofalk)+Hudi Enteric-coated Capsules Simulator;Jiangsu Province Hospital of Chinese MedicineNULLRecruiting1865BothTCM Group:120;Medical Group:120;Phase 4China
15ChiCTR1900023159
2019-05-202019-05-14Clinical evaluation of traditional Chinese medicine on moderate active ulcerative colitis: a multi-center, randomized, double-blind, controlled trialClinical evaluation of traditional Chinese medicine on moderate active ulcerative colitis: a multi-center, randomized, double-blind, controlled trial Ulcerative colitis?????????+???????(???)???:Qingchang Wenzhong Granules+Mesalazine Enteric-coated Tablets(Salofalk)Simulator;Medical Group:Mesalazine Enteric-coated Tablets(Salofalk)+Qingchang Wenzhong Granules Simulator;Combined Group:Qingchang Wenzhong Granules+Mesalazine Enteric-coated Tablets(Salofalk);Dongfang Hospital of Beijing University of Chinese MedicineNULLRecruiting1865Both?????????+???????(???)???:90;Medical Group:90;Combined Group:90;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2017-004576-57-PL
(EUCTR)
18/05/201901/08/2019Novel budesonide capsules vs. budesonide tabltes in patients with ulcerative colitis refractory to standard treatment with mesalazineRandomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 Patients with active ulcerative colitis refractory to standard treatment with mesalazine
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Trade Name: CortimentMMX 9 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
777Phase 3Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
17NCT03917095
(ClinicalTrials.gov)
May 15, 201912/4/2019The Safety and Efficacy of TET Enema in the Treatment of UCMesalazine and Compound Glutamin Enema for the Treatment of Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing: A Multicenter, Randomized, Controlled TrailUlcerative Colitis Chronic Mild;Ulcerative Colitis Chronic ModerateDevice: The Colonic Transendoscopic enteral Tubing.;Drug: Glutamine;Drug: MesalazineThe Second Hospital of Nanjing Medical UniversityNULLRecruiting18 Years65 YearsAll75N/AChina
18EUCTR2017-004576-57-DE
(EUCTR)
26/04/201908/01/2019Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazineRandomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 Patients with active ulcerative colitis refractory to standard treatment with mesalazine
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg prolonged-release capsule, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Product Name: Budesonide 6 mg prolonged-release capsule, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Trade Name: CortimentMMX 9 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
777Phase 3Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
19EUCTR2017-004576-57-LV
(EUCTR)
15/04/201914/01/2019Novel budesonide capsules vs. budesonide tables in patients with ulcerative colitis refractory to standard treatment with mesalazineRandomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 Patients with active ulcerative colitis refractory to standard treatment with mesalazine
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
777Phase 3Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Germany;Latvia
20EUCTR2017-004576-57-CZ
(EUCTR)
27/03/201915/03/2019Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazineRandomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 Patients with active ulcerative colitis refractory to standard treatment with mesalazine
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Trade Name: CortimentMMX 9 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
777Phase 3Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2017-004576-57-LT
(EUCTR)
15/03/201929/01/2019Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazineRandomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 Patients with active ulcerative colitis refractory to standard treatment with mesalazine
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg prolonged-release capsule, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Product Name: Budesonide 6 mg prolonged-release capsule, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Trade Name: CortimentMMX 9 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
777Phase 3Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
22EUCTR2017-004576-57-SK
(EUCTR)
12/03/201918/01/2019Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazineRandomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 Patients with active ulcerative colitis refractory to standard treatment with mesalazine
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Trade Name: CortimentMMX 9 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
777Phase 3Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
23EUCTR2017-004576-57-HU
(EUCTR)
11/03/201916/01/2019Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazineRandomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 Patients with active ulcerative colitis refractory to standard treatment with mesalazine
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Trade Name: CortimentMMX 9 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
777Phase 3Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
24JPRN-UMIN000034016
2018/12/0103/09/2018The investigation for maintenance therapy by mesalazine enema after remission induction by budesonide form enema in patients with ulcerative colitis: Multicenter randomized controlled studyThe investigation for maintenance therapy by mesalazine enema after remission induction by budesonide form enema in patients with ulcerative colitis: Multicenter randomized controlled study - STABILITY study ulcerative colitisAdditional remission maintenance therapy by mesalazine enema with continuation of concomitant treatment at the remission induction by budesonide form enema
The continuation of concomitant treatment at the remission induction by budesonide form enema (control group)
Hyogo College of MedicineNULLComplete: follow-up complete16years-oldNot applicableMale and Female84Not selectedJapan
25ChiCTR2000038316
2018-08-012020-09-17Effect of ursodeoxycholic acid on ulcerative colitis and serumal IL-23, IL-17 and intestinal flora levelsEffect of ursodeoxycholic acid on ulcerative colitis and serumal IL-23, IL-17 and intestinal flora levels Ulcerative colitiscontrol group:Mesalazine alone;trial group:Mesalazine and ursodeoxycholic acid soft capsule;Patients with mild bile reflux gastritis: ursodeoxycholic acid soft capsule;Healthy control group:Nil;The 900th Hospital of PLANULLCompleted1875Bothcontrol group:20;trial group:20;Patients with mild bile reflux gastritis:20;Healthy control group:20;Phase 4China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26ChiCTR1800016438
2018-06-302018-06-01Clinical research of flupentixol-melitracen and mesalazine on ulcerative colitisClinical research of flupentixol-melitracen and mesalazine on ulcerative colitis ulcerative colitiscontrol:mesalazine 1 po qid;observation group:mesalazine 1 po qid; flupentixol-melitracen 1pill po tid;Guiyang 1st People's HospitalNULLPending1575Bothcontrol:30;observation group:30;China
27JPRN-JapicCTI-173803
14/3/201808/12/2017Maintenance phase study of MD-0901 in pediatric ulcerative colitis.The clinical study to evaluate the efficacy, safety, and pharmacokinetics of MD-0901 in pediatric patients with ulcerative colitis in remission. Ulcerative colitis in remissionIntervention name : MD-0901
INN of the intervention : mesalazine
Dosage And administration of the intervention : Mesalazine 40 mg/day are administrated orally once daily after breakfast for 48 weeks.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
MOCHIDA PHARMACEUTICAL CO., LTDNULLrecruiting16BOTH26Japan
28NCT03412682
(ClinicalTrials.gov)
March 2, 201822/1/2018To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative ColitisA Phase 3, Multi-centre, Randomised, Double-blind, Active-controlled, Parallel-group Trial Investigating the Efficacy and Safety of FE 999315 Following 8 Weeks of Treatment for Mild to Moderate Active Ulcerative Colitis in Japanese SubjectsColitis, UlcerativeDrug: Budesonide (6 mg);Drug: Budesonide (9 mg);Drug: Mesalazine (3,600 mg)Ferring PharmaceuticalsNULLCompleted16 Years75 YearsAll274Phase 3Japan
29JPRN-JapicCTI-173802
30/1/201808/12/2017Active phase study of MD-0901 in pediatric ulcerative colitis.The clinical study to evaluate the efficacy, safety, and pharmacokinetics of MD-0901 in pediatric patients with mildly to moderately active ulcerative colitis. Mildly to moderately active ulcerative colitisIntervention name : MD-0901
INN of the intervention : mesalazine
Dosage And administration of the intervention : Mesalazine 80 mg/day are administrated orally once daily after breakfast for 8 weeks.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
MOCHIDA PHARMACEUTICAL CO., LTDNULLrecruiting16BOTH26Japan
30EUCTR2013-001744-65-BE
(EUCTR)
23/01/201827/02/2017A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative ColitisA Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases Mild to Moderate Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Mezavant Gastro-resistant, prolonged release tablets
Product Name: Mezavant
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Shire Development LLCNULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2013-001744-65-DE
(EUCTR)
10/01/201820/02/2017A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative ColitisA Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases Mild to Moderate Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Mezavant Gastro-resistant, prolonged release tablets
Product Name: Mezavant
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Shire Development LLCNULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden
32JPRN-UMIN000026175
2017/06/2301/03/2017Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitisComparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis - Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis Ulcerative colitisTime dependent mesalazine granule formulation After bottom of the 8th week from the start of administration, the lower endoscopy was performed and the mucous membrane was collected from the cecum and rectum by biopsy and the concentration of 5-ASA and acetyl 5-ASA in the mucosa was measured in the mucosa .

PH dependent mesalazine granule preparation Lower endoscopy was performed 8 weeks after the start of administration, mucosa was collected from the cecum and rectum by biopsy, and the concentration of 5-ASA and acetyl 5-ASA in the mucosa was measured at the drug part .
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu UniversityNULLComplete: follow-up complete20years-old99years-oldMale and Female60Not applicableJapan
33NCT03104036
(ClinicalTrials.gov)
June 19, 201727/3/2017Faecal Bacteriotherapy for Ulcerative ColitisFaecal Bacteriotherapy for Ulcerative ColitisUlcerative ColitisOther: Faecal bacterial transplantation;Drug: Mesalazine 4G EnemaInstitute for Clinical and Experimental MedicineInstitute of Animal Physiology and Genetics Academy of Science Czech RepublicRecruiting18 Years70 YearsAll60Phase 2Czechia;Czech Republic
34NCT03110198
(ClinicalTrials.gov)
May 201719/2/2017Mesalazine With Hydrocortisone Sodium Succinate Enema for 4-Week Treatment in Patients With Ulcerative ColitisA Randomized, Double-blind Study Investigating the Efficacy and Safety of Mesalazine With Hydrocortisone Sodium Succinate (100mg QD) Enema for 4-Week Treatment in Patients With Ulcerative Colitis (UC)Ulcerative Colitis, UnspecifiedDrug: Mesalazine;Drug: hydrocortisone sodium succinate;Drug: Mesalazine with hydrocortisone sodium succinateXijing Hospital of Digestive DiseasesShanghai Tongji Hospital, Tongji University School of Medicine;First Affiliated Hospital of Zhongshan Medical UniversityRecruiting18 Years70 YearsAll528Phase 4China
35ChiCTR-IPR-17010306
2017-02-012017-01-01Effects of probiotics on intestinal microecological reconstruction in patients with ulcerative colitisEffects of probiotics on intestinal microecological reconstruction in patients with ulcerative colitis Ulcerative colitisGroup A:Mesalazine combined with placebo; Group B:Methalazine combined with probiotics;Group C:Probiotics combined with placebo;Normal control group:Blank control;Affiliated Hospital of Inner Mongolia Medical UniversityNULLPending18BothGroup A:30; Group B:30;Group C:30;Normal control group:30;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2015-002557-35-LV
(EUCTR)
01/09/201601/07/2016A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative ColitisA Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis Active, mild to moderate ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Pentasa Compact 4g, granulate with prolonged release
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]
Ferring International PharmaScience Center U.S., Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Serbia;United States;Belarus;Ukraine;Ireland;Lithuania;Russian Federation;Switzerland;Hungary;Mexico;Canada;Belgium;Bulgaria;Latvia
37EUCTR2015-002558-11-LV
(EUCTR)
01/09/201601/07/2016A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative ColitisA Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis Ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Pentasa Compact 2g, granulate with prolonged release
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]
Ferring International PharmaScience Center U.S., Inc.NULLNot RecruitingFemale: yes
Male: yes
260Phase 3Serbia;United States;Belarus;Ukraine;Ireland;Lithuania;Russian Federation;Switzerland;Hungary;Mexico;Canada;Belgium;Bulgaria;Latvia
38EUCTR2013-001205-84-BE
(EUCTR)
11/03/201617/02/2015LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Trade Name: Salofalk Granu-Stix 500 mg
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
39EUCTR2013-001205-84-HU
(EUCTR)
07/03/201604/01/2016LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Trade Name: Salofalk Granu-Stix 500 mg
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
40EUCTR2015-002558-11-HU
(EUCTR)
09/02/201616/11/2015A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative ColitisA Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis - Ulcerative colitis
MedDRA version: 19.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Pentasa Compact 2g, granulate with prolonged release
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]
Ferring International PharmaScience Center U.S., Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 3Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2015-002557-35-HU
(EUCTR)
09/02/201616/11/2015A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative ColitisA Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis Active, mild to moderate ulcerative colitis
MedDRA version: 19.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Pentasa Compact 4g, granulate with prolonged release
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]
Ferring International PharmaScience Center U.S., Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland
42JPRN-UMIN000022954
2016/01/1505/07/2016A study related to usability of Mesalazine Controlled-Release Tablets and Granules. ulcerative colitisPatients take Mesalazine Controlled-release tablets at first, 3-12 weeks, then take granules, 3-12 weeks
Patients take Mesalazine Controlled-release granules at first, 3-12 weeks, then take tablets, 3-12 weeks
Kitasato University Kitasato Institute HospitalNULLRecruitingNot applicable100years-oldMale and Female60Not applicableJapan
43EUCTR2015-002558-11-BE
(EUCTR)
07/12/201504/11/2015A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative ColitisA Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis Ulcerative colitis
MedDRA version: 18.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Pentasa Compact 2g, granulate with prolonged release
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]
Ferring International PharmaScience Center U.S., Inc.NULLNot RecruitingFemale: yes
Male: yes
260Phase 3United States;Slovakia;Ukraine;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Latvia;New Zealand;Korea, Republic of
44EUCTR2015-002557-35-BE
(EUCTR)
07/12/201504/11/2015A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative ColitisA Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis Active, mild to moderate ulcerative colitis
MedDRA version: 18.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Pentasa Compact 4g, granulate with prolonged release
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]
Ferring International PharmaScience Center U.S., Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3United States;Slovakia;Ukraine;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Latvia
45NCT02368743
(ClinicalTrials.gov)
December 201516/2/2015QUality of Life in pAtients With Mild to modeRate Active procTitis Treated by mesalaZine (Pentasa®)QUality of Life in pAtients With Mild to modeRate Active procTitis Treated by mesalaZine (Pentasa®)Distal Ulcerative ColitisDrug: mesalazineFerring PharmaceuticalsNULLCompleted18 YearsN/AAll117France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2013-001205-84-AT
(EUCTR)
13/10/201502/09/2015LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Trade Name: Salofalk Granu-Stix 500 mg
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
47ChiCTR-IOR-15007194
2015-10-102015-08-26The randomized, controlled, double blind clinical trial of Qingchang Wenzhongs in the treatment of ulcerative colitis.The randomized, controlled, double blind clinical trial of Qingchang Wenzhongs in the treatment of ulcerative colitis. Ulreative colitisQing chang wen zhong: Qing chang wen zhong of traditional Chinese medicine;Mesalazine:Mesalazine;Dongfang hospital, Beijing univetsity of Chinese MedicineNULLRecruiting1665BothQing chang wen zhong:36;Mesalazine:36;China
48ChiCTR-ICR-15007188
2015-10-092015-10-09Percutaneous endoscopic mini-colostomy anddrug delivery system for the treatment of ulcerative colitis: A randomized, controlled clinical trialPercutaneous endoscopic mini-colostomy anddrug delivery system for the treatment of ulcerative colitis: A randomized, controlled clinical trial Ulcerative colitisPercutaneous endoscopic mini-colostomy group:Oral steroids (prednisone 1mg.kg-1d-1) +Percutaneous endoscopic mini-colostomy andsubsequent drug delivery (mesalazine 3g / d);Control Group:Oral steroids (prednisone 1mg.kg-1d-1) andmesalazine 3g / d;Southern Medical University, Nanfang Hospital, Department of GastroenterologyNULLRecruitingBothPercutaneous endoscopic mini-colostomy group:21;Control Group:21;China
49NCT02537210
(ClinicalTrials.gov)
September 201528/8/2015Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative ColitisOral 5-aminosalicylic Acid Withdrawal in Long Standing Inactive Ulcerative Colitis: A Double-blind, Randomized, Placebo-controlled TrialColitis, Ulcerative;Aminosalicylic AcidDrug: Mesalazine;Drug: Placebo oral capsuleChinese University of Hong KongQueen Elizabeth Hospital, Hong Kong;Alice Ho Miu Ling Nethersole Hospital;Tseung Kwan O Hospital, Hong KongRecruiting18 YearsN/AAll194N/AHong Kong;China
50EUCTR2013-000366-11-RO
(EUCTR)
25/03/201511/03/2015Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Serbia;Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2013-001205-84-SK
(EUCTR)
23/03/201505/02/2015LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Trade Name: Salofalk Granu-Stix 500 mg
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
52EUCTR2013-001744-65-NL
(EUCTR)
02/03/201507/08/2014A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative ColitisA Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases Mild to Moderate Ulcerative Colitis
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Shire Devlopment LLCNULLNot Recruiting Female: yes
Male: yes
128Phase 3United States;Hungary;Slovakia;Canada;Belgium;Poland;Israel;Germany;Netherlands;United Kingdom
53NCT02368717
(ClinicalTrials.gov)
March 201516/2/2015An Efficacy and Safety Study of PENTASA in Chinese Patients With Left-sided Active Ulcerative Colitis Followed by a 24-Week Open-Label Extension PhaseA Randomized, Double-blind, Placebo-controlled, Multi-centre, Superiority Study Investigating the Efficacy and Safety of PENTASA Enema Compared With Placebo Enema for 4-Week Treatment in Chinese Patients With Left-sided Active Ulcerative Colitis (UC) Followed by a Maximal 28-Week Open-Label Extension Phase of PENTASA Enema and/or PENTASA TabletsUlcerative ColitisDrug: Mesalazine Enema;Drug: Placebo EnemaFerring PharmaceuticalsNULLCompleted18 Years70 YearsAll281Phase 3China
54EUCTR2013-001205-84-LV
(EUCTR)
26/02/201523/12/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Trade Name: Salofalk Granu-Stix 500 mg
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Latvia;Germany;Netherlands
55EUCTR2013-001205-84-PL
(EUCTR)
20/01/201522/09/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Trade Name: Salofalk Granu-Stix 500 mg
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Poland;Belgium;Germany;Latvia;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2013-001205-84-DE
(EUCTR)
13/01/201508/08/2014LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitisRandomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Trade Name: Salofalk Granu-Stix 500 mg
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
57NCT03441893
(ClinicalTrials.gov)
January 1, 20158/2/2018Role of Intestinal Protozoa and Helminths in the Course of Ulcerative ColitisRole of Intestinal Protozoa and Helminths in the Course of Ulcerative ColitisUlcerative Colitis;Ulcerative Colitis Exacerbation;Protozoan Infections;Helminth InfectionDiagnostic Test: parasitological diagnostics (coproscopy);Drug: Nitazoxanide 500Mg Oral Tablet;Drug: Mesalazine 250Mg Tablet and nitazoxanide 500Mg Oral Tablet;Drug: Mesalazine 250MgResearch Institute of Epidemiology, Microbiology and Infectious Diseases, UzbekistanNULLActive, not recruiting18 Years90 YearsAll300Phase 1;Phase 2NULL
58NCT02261636
(ClinicalTrials.gov)
January 20157/10/2014Induction and Maintenance of Remission With Pentasa as Ulcerative Colitis TreatmentUlcerative ColitisDrug: mesalazineFerring PharmaceuticalsNULLCompleted18 Years70 YearsAll150Netherlands
59NCT02335281
(ClinicalTrials.gov)
January 20157/1/2015Standardized Fecal Microbiota Transplantation for Inflammatory Bowel DiseaseEfficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation for Severe Inflammatory Bowel DiseaseInflammatory Bowel Disease;Ulcerative Colitis;Crohn's DiseaseProcedure: FMT;Drug: MesalazineYanling WeiNULLRecruiting16 Years70 YearsBoth40Phase 2China
60NCT02093663
(ClinicalTrials.gov)
December 12, 201417/3/2014Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative ColitisA Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis, in Both Acute and Maintenance PhasesUlcerative ColitisDrug: MMX Mesalamine/Mesalazine (Low Dose);Drug: MMX Mesalamine/Mesalazine (High Dose)ShireNULLCompleted5 Years17 YearsAll107Phase 3United States;Canada;Hungary;Israel;Poland;Slovakia;United Kingdom;Belgium;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2013-001744-65-GB
(EUCTR)
22/10/201431/03/2014A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative ColitisA Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases Mild to Moderate Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Shire Development LLCNULLNot Recruiting Female: yes
Male: yes
132Phase 3United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden
62ChiCTR1800016668
2014-10-222018-06-14A randomized, double-blind, double-dummy, positive controlled clinical trial of Hudi enteric-coated capsules, mesalazine, and combination therapy for active ulcerative colitis (damp-heat syndrome)A randomized, double-blind, double-dummy, positive controlled clinical trial of Hudi enteric-coated capsules, mesalazine, and combination therapy for active ulcerative colitis (damp-heat syndrome) Active ulcerative colitistest group:Hudi enteric-coated capsules+Mesalazine enteric-coated tablets Simulator;Positive control group:Mesalazine enteric-coated tablets+Hudi Enteric-coated Capsule Simulator;Combined group:Hudi enteric-coated capsules+Mesalazine enteric-coated tablets;Affiliated Hospital of Nanjing University of Traditional Chinese Medicine (Jiangsu Province Traditional Chinese Medicine Hospital)NULLCompleted1865Bothtest group:120;Positive control group:120;Combined group:120;China
63EUCTR2013-001744-65-PL
(EUCTR)
20/10/201419/08/2014A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative ColitisA Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases Mild to Moderate Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Mezavant Gastro-resistant, prolonged release tablets
Product Name: Mezavant
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Shire Devlopment LLCNULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;Hungary;Slovakia;Canada;Belgium;Poland;Israel;Netherlands;Germany;United Kingdom;Sweden
64EUCTR2013-001744-65-HU
(EUCTR)
24/09/201415/07/2014A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative ColitisA Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases Mild to Moderate Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalazine
Shire Devlopment LLCNULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom
65EUCTR2013-001744-65-SK
(EUCTR)
11/09/201417/07/2014A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative ColitisA Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases Mild to Moderate Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Shire Devlopment LLCNULLNot Recruiting Female: yes
Male: yes
132Phase 3United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2013-000366-11-SK
(EUCTR)
19/06/201421/05/2014Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Denmark;Bulgaria;Latvia;Sweden
67ChiCTR-OCH-14004615
2014-05-122014-05-07Prospective cohort study of Qing Chang Wen Zhong decoction in the treatment of patients with mild and moderate ulcerative colitis.Prospective cohort study of qingchangwenzhong decoction in the treatment of patients with mild and moderate ulcerative colitis. ulcerative colitisclinical group:Qing Chang Wen Zhong decoction;control:Mesalazine Enteric-coated Tablets or Medichemie Ettingen;Dongfang Hospital Affiliated to Beijing University of Traditional Chinese MedicineNULLCompleted1865Bothclinical group:60;control:60;China
68EUCTR2013-000366-11-BG
(EUCTR)
23/04/201406/03/2014Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
69ChiCTR-IOR-15006812
2014-04-012015-07-26Effect of dispelling wind and eliminating dampness therapy in mucosal healing of ulcerative colitisEffect of dispelling wind and eliminating dampness therapy in mucosal healing of ulcerative colitis ulcerative colitisintervetion group:wind-dispelling and damp-eliminating glanules;control group:Mesalazine;Department of anorectal surgery, Dongzhimen Hospital, Beijing University of Chinese MedicineNULLRecruiting1870Bothintervetion group:30;control group:30;China
70EUCTR2013-000366-11-LV
(EUCTR)
14/03/201407/02/2014Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2013-000366-11-LT
(EUCTR)
10/03/201422/01/2014Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
72EUCTR2013-000366-11-HU
(EUCTR)
24/02/201428/11/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
73JPRN-JapicCTI-142475
24/12/2013Phase 3 Clinical Trial with MD-0901Phase 3 Clinical Trial with MD-0901 Mild to moderate active ulcerative colitisIntervention name : MD-0901
INN of the intervention : Mesalazine
Dosage And administration of the intervention : Mesalazine 4.8 g/d are administrated orally once daily after breakfast for 8 weeks.
Control intervention name : Asacol tablet
INN of the control intervention : Mesalazine
Dosage And administration of the control intervention : Mesalazine 3.6 g/d are administrated orally 3 times daily after each meal for 8 weeks.
MOCHIDA PHARMACEUTICAL CO., LTD.NULL16BOTH250Phase 3NULL
74EUCTR2013-000366-11-PL
(EUCTR)
12/12/201305/09/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Latvia;Sweden
75EUCTR2013-000366-11-ES
(EUCTR)
07/10/201312/07/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Belarus;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Latvia;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76JPRN-UMIN000010127
2013/09/2401/04/2013Comparative study for mucosal concentration of 5-ASA by once-daily vs divided dosing of oral mesalazine in quiescent ulcerative colitis ulcerative colitisEligible patients will be treated with 3g of oral mesalazine once daily for at least two weeks
Eligible patients will be treated with 3g of oral mesalazine twice daily for at least two weeks
Eligible patients will be treated with 3g of oral mesalazine three times daily for at least two weeks
Department of Gastroenterology and Hepatology, Kyoto University HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female50Not applicableJapan
77EUCTR2013-000366-11-CZ
(EUCTR)
12/09/201305/06/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
78EUCTR2013-000366-11-BE
(EUCTR)
02/09/201311/07/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
79NCT02306798
(ClinicalTrials.gov)
September 201315/10/2014TP0502-B-Pharmaco-Scintigraphic-StudyAn Open Label, Single-site Pharmaco-Scintigraphic Study in Healthy Subjects With Radio-labelled TP05-tablets (Mesalazine) to Evaluate the Gastrointestinal Transit and Release ProfileUlcerative ColitisDrug: TP05Tillotts Pharma AGNULLCompleted18 Years55 YearsBoth9Phase 1NULL
80EUCTR2013-000366-11-FI
(EUCTR)
20/08/201305/07/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2013-000366-11-IE
(EUCTR)
17/07/201316/05/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
82EUCTR2013-000366-11-DK
(EUCTR)
10/07/201310/07/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
83EUCTR2013-000366-11-SE
(EUCTR)
28/06/201313/05/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
84JPRN-UMIN000010906
2013/06/1010/06/2013The exploratory randomized controlled trial by high-dose Asacol treatment to patients with ulcerative colitis aiming to maintain remission. Ulcerative ColitisA 24-week administration of 4.8g/day of Asacol
A 24-week administration of the mesalazine which the patients have taken before the treatment of 4.8g/day of Asacol as induction therapy
Chiba University HospitalNULLComplete: follow-up complete15years-old70years-oldMale and Female60Phase 2Japan
85JPRN-JapicCTI-132135
01/5/2013Phase III Study of Z-206Phase III Study of Z-206 Ulcerative ColitisIntervention name : Z-206
INN of the intervention : Mesalazine
Dosage And administration of the intervention : Mesalazine at the dose 2.4g/day is administered once a day or three times a day.
Control intervention name : null
Zeria Pharmaceutical Co., Ltd.Kyowa Hakko Kirin Co., Ltd.1664BOTH600Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86JPRN-UMIN000010340
2013/05/0101/04/2013Comparison of rectal with oral mesalazine in the treatment of Ulcerative Proctitis (CORRECT Study) Ulcerative colitisRandomized treatment with mesalazine suppository or oral mesalazine for 2 weeks
Switch from oral mesalazine to mesalazine suppository for 2 weeks
Saitama Medical Center, Saitama Medical UniversityNULLComplete: follow-up complete18years-oldNot applicableMale and Female60Not selectedJapan
87EUCTR2012-001830-32-LT
(EUCTR)
04/02/201304/10/2012A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitisDouble-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis - TID 1000 mg mesalazine versus TID 2x500 mg mesalazine in active UC Active ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mesalazine 1000 mg gastro-resistant tablets
Product Code: Mesalazine 1000 mg gastro-resistant tablets
INN or Proposed INN: Mesalazine
Trade Name: Salofalk® 500 mg gastro-resistant tablet
Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg)
Product Code: Mesalazine 500 mg gastro-resistant tablets (Salofa
INN or Proposed INN: Mesalazine
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Hungary;Poland;Ukraine;Lithuania;Russian Federation;Latvia
88EUCTR2012-001830-32-PL
(EUCTR)
01/02/201318/10/2012A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitisDouble-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis - TID 1000 mg mesalazine versus TID 2x500 mg mesalazine in active UC Active ulcerative colitis
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mesalazine 1000 mg gastro-resistant tablets
Product Code: Mesalazine 1000 mg gastro-resistant tablets
INN or Proposed INN: Mesalazine
Trade Name: Salofalk® 500 mg gastro-resistant tablet
Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg)
Product Code: Mesalazine 500 mg gastro-resistant tablets (Salofa
INN or Proposed INN: Mesalazine
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Hungary;Poland;Ukraine;Lithuania;Russian Federation;Latvia
89EUCTR2012-001830-32-DE
(EUCTR)
15/01/201314/08/2012A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitisDouble-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis - TID 1000 mg mesalazine versus TID 2x500 mg mesalazine in active UC Active ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mesalazine 1000 mg gastro-resistant tablets
Product Code: Mesalazine 1000 mg gastro-resistant tablets
INN or Proposed INN: Mesalazine
Trade Name: Salofalk® 500 mg gastro-resistant tablet
Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg)
Product Code: Mesalazine 500 mg gastro-resistant tablets (Salofa
INN or Proposed INN: Mesalazine
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Hungary;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
90EUCTR2011-000164-10-GB
(EUCTR)
04/01/201319/09/2012Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative ColitisA Phase 1, Multicenter, Open-label Study to Determine the Safety and Pharmacokinetics of MMX Mesalamine Following Administration in Children and Adolescents With Ulcerative Colitis Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: SPD476
INN or Proposed INN: mesalazine
Product Code: SPD476
INN or Proposed INN: mesalazine
Trade Name: Mezavant XL 1200mg gastro-resistant, prolonged release tablets
Product Code: SPD476
INN or Proposed INN: mesalazine
Shire Development LLCNULLNot RecruitingFemale: yes
Male: yes
64Phase 1United States;Slovakia;Poland;Australia;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT01745770
(ClinicalTrials.gov)
January 20135/12/2012TID 1000 mg Mesalazine Versus TID 2x500 mg Mesalazine in Active Ulcerative Colitis (UC)Double-blind, Double-dummy, Randomised, Multi-centre, Comparative Phase III Clinical Study on the Efficacy and Tolerability of an 8 Week Oral Treatment With Three Times Daily 1000 mg Mesalazine Versus Three Times Daily 2x500 mg Mesalazine in Patients With Active Ulcerative ColitisActive Ulcerative ColitisDrug: Mesalazine - TID 1000 mg;Drug: Mesalazine - TID 2x 500 mgDr. Falk Pharma GmbHNULLCompleted18 Years75 YearsBoth306Phase 3Germany
92EUCTR2012-004851-35-FI
(EUCTR)
19/12/201207/12/2012Mesalalazine in pediatric ulcerative colitisOnce versus twice daily mesalazine to introduce remission in pediatric ulcerative colitis: a randomized controlled trial Ulcerative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Children´s Hospital, University of HelsinkiNULLNot Recruiting Female: yes
Male: yes
200Phase 4Finland;Israel
93EUCTR2012-001830-32-HU
(EUCTR)
04/10/201216/08/2012A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitisDouble-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis - TID 1000 mg mesalazine versus TID 2x500 mg mesalazine in active UC Active ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mesalazine 1000 mg gastro-resistant tablets
Product Code: Mesalazine 1000 mg gastro-resistant tablets
INN or Proposed INN: Mesalazine
Trade Name: Salofalk® 500 mg gastro-resistant tablet
Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg)
Product Code: Salofalk® 500 mg tablets
INN or Proposed INN: Mesalazine
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Hungary;Poland;Ukraine;Lithuania;Russian Federation;Latvia
94EUCTR2012-001830-32-LV
(EUCTR)
02/10/201205/09/2012A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitisDouble-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis - TID 1000 mg mesalazine versus TID 2x500 mg mesalazine in active UC Active ulcerative colitis
MedDRA version: 15.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mesalazine 1000 mg gastro-resistant tablets
Product Code: Mesalazine 1000 mg gastro-resistant tablets
INN or Proposed INN: Mesalazine
Trade Name: Salofalk® 500 mg gastro-resistant tablet
Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg)
Product Code: Mesalazine 500 mg gastro-resistant tablets (Salofa
INN or Proposed INN: Mesalazine
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Hungary;Poland;Ukraine;Lithuania;Russian Federation;Germany;Latvia
95EUCTR2012-002023-15-AT
(EUCTR)
21/09/201204/09/2012Mesacol: The effect of mesalazine on molecular pathways ofcell adhesion in ulcerative colitisMesacol: The effect of mesalazine on molecular pathways ofcell adhesion in ulcerative colitis - Mesacol Ulcerative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Mezavant 1200 mg magensaftresistente Retardtabletten
INN or Proposed INN: MESALAZINE
Other descriptive name: 5-aminosalicylic acid
Medizinische Universität Wien, Universitätsklinik für Innere Medizin 3, Abteilung für Gastroenterologie und HepatologieNULLNot RecruitingFemale: yes
Male: yes
12Phase 2Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96JPRN-UMIN000008352
2012/08/0101/08/2012Switch Trial from Several Times to Once Daily Oral Mesalazine Administration in Patients with Quiescent Ulcerative Colitis Ulcerative ColitisSwitch from several times to once daily oral mesalazine administrationSaitama Medical Center, Saitama Medical UniversityNULLComplete: follow-up complete15years-old70years-oldMale and Female50Not selectedJapan
97NCT01536535
(ClinicalTrials.gov)
July 10, 201216/2/2012Predicting Response to Standardized Pediatric Colitis TherapyMulticenter Open-label Study Evaluating the Safety and Efficacy of Standardized Initial Therapy Using Either Mesalamine or Corticosteroids Then Mesalamine to Treat Children and Adolescents With Newly Diagnosed Ulcerative Colitis.Ulcerative ColitisDrug: Mesalazine;Drug: IV Corticosteroid;Drug: Oral Corticosteroids;Other: Additional Therapies;Procedure: ColectomyConnecticut Children's Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed4 Years17 YearsAll431Phase 4United States;Canada
98EUCTR2011-000164-10-SK
(EUCTR)
21/06/201213/04/2016Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative ColitisA Phase 1, Multicenter, Open-label Study to Determine the Safety and Pharmacokinetics of MMX Mesalamine Following Administration in Children and Adolescents With Ulcerative Colitis Ulcerative Colitis
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SPD476
Product Code: SPD476
INN or Proposed INN: mesalazine
Product Name: SPD476
Product Code: SPD476
INN or Proposed INN: mesalazine
Product Name: SPD476
Product Code: SPD476
INN or Proposed INN: mesalazine
Shire Development IncNULLNot RecruitingFemale: yes
Male: yes
60Phase 1United States;Slovakia;United Kingdom
99NCT01517607
(ClinicalTrials.gov)
February 201220/1/2012Mesalazine (PENTASA®) in Ulcerative ColitisMesalazine (PENTASA®) in Ulcerative Colitis: Correlation of the Information Level With Patient's Compliance in Everyday PracticeUlcerative ColitisOther: MesalazineFerring PharmaceuticalsFerring Arzneimittel GmbHCompleted18 YearsN/ABoth506N/AGermany
100NCT02306772
(ClinicalTrials.gov)
December 201115/10/2014TP0501 - Pharmaco-Scintigraphic-StudyAn Open Label, Single-site Pharmaco-Scintigraphic Study in Healthy Subjects With Radio-labelled TP05-tablets (Mesalazine) to Evaluate the Gastrointestinal Transit and Release Profiles of Two Different Formulations.Ulcerative ColitisDrug: TP05 Coating A;Drug: TP05 Coating BTillotts Pharma AGNULLCompleted18 Years55 YearsBoth18Phase 1NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101JPRN-UMIN000011236
2011/05/0220/07/2013Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation -Efficacy of on-demand therapy for induction and maintenance of remission - Ulcerative colitisUpon appearance of rectal bleeding, once daily administration of a 500 mg mesalazine suppository until disappearance of rectal bleeding.Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of MedicineNULLComplete: follow-up complete15years-old65years-oldMale and Female200Not selectedJapan
102JPRN-JapicCTI-101381
15/11/2010Remission Phase Study with MD-0901 -Phase 3 Clinical Trial in Patients with Ulcerative Colitis in Remission Phase-Remission Phase Study with MD-0901 -Phase 3 Clinical Trial in Patients with Ulcerative Colitis in Remission Phase- Ulcerative colitis in remission phaseIntervention name : MD-0901
INN of the intervention : Mesalazine
Dosage And administration of the intervention : Mesalazine 2.4 g/d are administrated orally once daily after breakfast for 48 weeks.
Control intervention name : Mesalazine tablet
INN of the control intervention : Mesalazine
Dosage And administration of the control intervention : Mesalazine 2.25g/d are administrated orally 3 times daily after each meal for 48 weeks.
MOCHIDA PHARMACEUTICAL CO., LTD.NULL16BOTH190Phase 3NULL
103JPRN-JapicCTI-101380
15/11/2010Active Phase Study with MD-0901 -Phase 3 Clinical Trial in Patients with Mild to Moderate Active Ulcerative Colitis-Active Phase Study with MD-0901 -Phase 3 Clinical Trial in Patients with Mild to Moderate Active Ulcerative Colitis- Mild to moderate active ulcerative colitisIntervention name : MD-0901
INN of the intervention : Mesalazine
Dosage And administration of the intervention : Mesalazine 2.4 g/d or 4.8 g/d are administrated orally once daily after breakfast for 8 weeks.
Control intervention name : Mesalazine tablet
INN of the control intervention : Mesalazine
Dosage And administration of the control intervention : Mesalazine 2.25 g/d are administrated orally 3 times daily after each meal for 8 weeks.
MOCHIDA PHARMACEUTICAL CO., LTD.NULL16BOTH228Phase 3NULL
104EUCTR2010-018557-35-NL
(EUCTR)
08/11/201011/02/2010Desensitisation of ulcerative colitis patients intolerant for mesalazine treatment. - Desensitisation for mesalazineDesensitisation of ulcerative colitis patients intolerant for mesalazine treatment. - Desensitisation for mesalazine Ulcerative colitisTrade Name: Mesalazine
Product Name: Mesalazine
Product Code: Salofalk
University Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Netherlands
105EUCTR2009-017044-13-DE
(EUCTR)
03/11/201016/06/2010A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitisA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM Ulcerative Colitis
MedDRA version: 13.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: MMX Mesalamine/Mesalazine
Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: MMX Mesalamine/Mesalazine
Shire Development IncNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3b;Phase 4United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106NCT01257386
(ClinicalTrials.gov)
November 20108/12/2010Comparative Efficacy and Safety Study in Patients With Active Ulcerative ColitisComparative Efficacy and Safety Study in Patients With Active Ulcerative ColitisActive Ulcerative ColitisDrug: Asacol®;Drug: MesalazineTillotts Pharma AGZeria PharmaceuticalCompleted18 Years64 YearsBoth251Phase 3China
107NCT01257399
(ClinicalTrials.gov)
November 20108/12/2010Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission PhaseComparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission PhaseUlcerative Colitis in RemissionDrug: Asacol®;Drug: MesalazineTillotts Pharma AGZeria PharmaceuticalCompleted18 Years64 YearsBoth251Phase 3China
108EUCTR2009-017044-13-BE
(EUCTR)
14/09/201006/05/2010A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitisA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: MMX Mesalamine/Mesalazine
Shire Development LLCNULLNot RecruitingFemale: yes
Male: yes
1000Phase 4United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Belgium;Poland;South Africa;Germany
109EUCTR2009-017044-13-IE
(EUCTR)
10/08/201020/04/2010A study to Evaluate the Ability to Maintain Clinical andEndoscopic Remission During a 12-Month period with 2.4g/day of druggiven once a day in adults with ulcerative colitisA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: MMX Mesalamine/Mesalazine
Shire Development LLCNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3b;Phase 4United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany
110EUCTR2009-017044-13-CZ
(EUCTR)
05/08/201028/05/2010A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitisA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: MMX Mesalamine/Mesalazine
Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: MMX Mesalamine/Mesalazine
Shire Development LLCNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3b;Phase 4Hungary;Canada;Poland;South Africa;Germany;United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111EUCTR2009-017044-13-FR
(EUCTR)
27/07/201022/06/2010A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative ColitisA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis Ulcerative Colitis
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: MMX Mesalamine/Mesalazine
Shire Development IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3b;Phase 4Hungary;Germany;Czech Republic;United Kingdom;France;Ireland;Spain
112EUCTR2009-017044-13-HU
(EUCTR)
21/07/201026/04/2010A Study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitisA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: MMX Mesalamine/Mesalazine
Shire Development LLCNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3b;Phase 4United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany
113EUCTR2009-017044-13-GB
(EUCTR)
30/06/201017/03/2010A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/day MMX® Mesalamine/mesalazine Once Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Shire Development LLCNULLNot Recruiting Female: yes
Male: yes
1000Phase 4United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Belgium;South Africa;Germany
114NCT01124149
(ClinicalTrials.gov)
June 29, 201013/5/2010Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative ColitisA Phase 4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/Day MMX Mesalamine/Mesalazine Once Daily in Adult Subjects With Ulcerative ColitisUlcerative ColitisDrug: MMX mesalamine/ mesalazineShireNULLCompleted18 YearsN/AAll759Phase 4United States;Belgium;Canada;Colombia;Czechia;France;Germany;Hungary;India;Ireland;Poland;Romania;South Africa;Spain;United Kingdom;Brazil;Czech Republic
115EUCTR2009-017044-13-ES
(EUCTR)
25/06/201019/04/2010Estudio en fase 3b/4, abierto, multicéntrico y prospectivo para evaluar el efecto del estado de la remisión sobre la capacidad para mantener o alcanzar la remisión clínica y endoscópica durante una fase de mantenimiento a largo plazo de 12 meses con 2,4 g/día de MMX mesalamina/mesalazina una vez al día en pacientes adultos con colitis ulcerosaA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative ColitisEstudio en fase 3b/4, abierto, multicéntrico y prospectivo para evaluar el efecto del estado de la remisión sobre la capacidad para mantener o alcanzar la remisión clínica y endoscópica durante una fase de mantenimiento a largo plazo de 12 meses con 2,4 g/día de MMX mesalamina/mesalazina una vez al día en pacientes adultos con colitis ulcerosaA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis Colitis UlcerosaUlcerative Colitis
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
INN or Proposed INN: MESALAZINE
Other descriptive name: MMX Mesalamine/Mesalazine
Shire Development Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3b;Phase 4Hungary;Germany;Czech Republic;United Kingdom;France;Ireland;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116NCT01011322
(ClinicalTrials.gov)
December 200910/11/2009A Study to Investigate the Efficacy of LT-02 in Patients With Mesalazine Refractory Ulcerative ColitisUlcerative Colitis;Large Intestine;Diarrhea;Abdominal PainDrug: LT-02;Drug: placeboLipid Therapeutics GmbHNULLActive, not recruiting18 YearsN/ABoth156Phase 2Germany;Lithuania;Romania
117EUCTR2008-007952-90-LT
(EUCTR)
23/11/200915/09/2009A randomized, multi-center, doubleblind, parallel group, placebocontrolled, phase IIb, dose ranging study to investigate the efficacy and safety of LT-02 in patients with mesalazine-refractory ulcerative colitis.A randomized, multi-center, doubleblind, parallel group, placebocontrolled, phase IIb, dose ranging study to investigate the efficacy and safety of LT-02 in patients with mesalazine-refractory ulcerative colitis. Patients with ulcerative colitis (UC) according to European Crohn's and Colitis Organisation (ECCO) consensus; Simple Clinical Colitis Activity Index (SCCAI) =5 and SCCAI subscore for blood in stool” =2 at Baseline Visit.
MedDRA version: 12.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: LT-02 (modified-release PC pellets)
Product Code: LT-02
INN or Proposed INN: Modified-release phosphatidylcholine
Product Name: LT-02 (modified-release PC pellets)
Product Code: LT-02
INN or Proposed INN: Modified-release phosphatidylcholine
Product Name: LT-02 (modified-release PC pellets)
Product Code: LT-02
INN or Proposed INN: Modified-release phosphatidylcholine
Lipid Therapeutics GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 2bGermany;Lithuania
118EUCTR2008-007952-90-DE
(EUCTR)
17/11/200904/08/2009A randomized, multi-center, doubleblind, parallel group, placebocontrolled, phase IIb, dose ranging study to investigate the efficacy and safety of LT-02 in patients with mesalazine-refractory ulcerative colitis. - Amendment No. 3 (Version 1.0), 16-JUL-2010A randomized, multi-center, doubleblind, parallel group, placebocontrolled, phase IIb, dose ranging study to investigate the efficacy and safety of LT-02 in patients with mesalazine-refractory ulcerative colitis. - Amendment No. 3 (Version 1.0), 16-JUL-2010 Patients with ulcerative colitis (UC) according to European Crohn's and Colitis Organisation (ECCO) consensus; Simple Clinical Colitis Activity Index (SCCAI) =5 and SCCAI subscore for blood in stool” =2 at Baseline Visit.
MedDRA version: 12.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: LT-02 (modified-release PC pellets)
Product Code: LT-02
INN or Proposed INN: Modified-release phosphatidylcholine
Product Name: LT-02 (modified-release PC pellets)
Product Code: LT-02
INN or Proposed INN: Modified-release phosphatidylcholine
Product Name: LT-02 (modified-release PC pellets)
Product Code: LT-02
INN or Proposed INN: Modified-release phosphatidylcholine
Lipid Therapeutics GmbHNULLNot RecruitingFemale: yes
Male: yes
240Phase 2bGermany;Lithuania
119EUCTR2009-011608-51-DE
(EUCTR)
09/10/200921/07/2009A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative ColitisA Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis Ulcerative colitis
MedDRA version: 15.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
Product Name: GSK1399686
Product Code: GSK1399686
Trade Name: ASACOL
Product Name: ASACOL
Product Code: ASACOL
INN or Proposed INN: mesalazine
Other descriptive name: Overencapsulated mesalazine tablets
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686
GlaxoSmithKline Research and Development Ltd.NULLNot RecruitingFemale: yes
Male: yes
60Germany;Sweden
120EUCTR2004-004184-29-DK
(EUCTR)
10/09/200910/10/2007A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
830Phase 3Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121EUCTR2009-010921-38-NL
(EUCTR)
08/09/200902/03/2009Chemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis:A Double-blind, Randomized Placebo-controlled Pilot Study - CRC chemoprevention in UCChemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis:A Double-blind, Randomized Placebo-controlled Pilot Study - CRC chemoprevention in UC Ulcerative Colitis and the risk of developing colorectal cancer.
MedDRA version: 13.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders
Trade Name: Salofalk
INN or Proposed INN: mesalazine
Trade Name: Ursofalk
INN or Proposed INN: ursodeoxycholic acid
UMC UtrechtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
122EUCTR2009-011608-51-SE
(EUCTR)
17/08/200922/06/2009A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative ColitisA Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: GSK1399686
Product Code: GSK1399686
Trade Name: ASACOL
Product Name: ASACOL
Product Code: ASACOL
INN or Proposed INN: mesalazine
Other descriptive name: Overencapsulated mesalazine tablets
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686
GlaxoSmithKline Research and Development LtdNULLNot RecruitingFemale: yes
Male: yes
60Germany;Sweden
123EUCTR2009-011608-51-BE
(EUCTR)
03/08/200923/06/2009A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative ColitisA Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: GSK1399686
Product Code: GSK1399686
Trade Name: ASACOL
Product Name: ASACOL
Product Code: ASACOL
INN or Proposed INN: mesalazine
Other descriptive name: Overencapsulated mesalazine tablets
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686
GlaxoSmithKline Research and Development LtdNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Belgium;Germany;Sweden
124EUCTR2008-004610-27-SK
(EUCTR)
06/04/200909/02/2009A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitisA double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis Mild to moderate active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: Dersalazine sodium
Product Code: UR-12746-S
INN or Proposed INN: dersalazine sodium
Trade Name: Lixacol
Product Name: Lixacol
INN or Proposed INN: Mesalazine
Trade Name: Lixacol
Product Name: Lixacol
INN or Proposed INN: mesalazine
Palau Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
90Phase 2Hungary;Slovakia;Spain;Belgium
125EUCTR2008-007292-25-IT
(EUCTR)
24/03/200916/03/2009AN OPEN, PILOT PHASE III, RANDOMIZED CLINICAL TRIAL TO ASSESS THE TISSUTAL PHARMAKINETICS OF MESALAZINE TABLETS IN PATIENTS WITH MILD TO MODERATE LEFT-SIDED ULCERATIVE COLITIS IN ACTIVE PHASE - GIU-5-ASA1.2 MMx-02-08AN OPEN, PILOT PHASE III, RANDOMIZED CLINICAL TRIAL TO ASSESS THE TISSUTAL PHARMAKINETICS OF MESALAZINE TABLETS IN PATIENTS WITH MILD TO MODERATE LEFT-SIDED ULCERATIVE COLITIS IN ACTIVE PHASE - GIU-5-ASA1.2 MMx-02-08 Patients with established diagnosis of left-sided UC (rectum-sigmoid colon or colon up to the splenic flexure)
MedDRA version: 9.1;Level: LLT;Classification code 10024123;Term: Left-sided ulcerative (chronic) colitis
Trade Name: MEZAVANT
INN or Proposed INN: Mesalazine
Trade Name: ASACOL
INN or Proposed INN: Mesalazine
GIULIANINULLNot RecruitingFemale: yes
Male: yes
Phase 3Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126EUCTR2008-000045-59-GB
(EUCTR)
17/03/200915/07/2008Multicentre, controlled, randomized, investigator-blinded, comparative study of oral mesalazine 4g per day once daily versus 4g per day in two divided doses in patients with active ulcerative colitis. - MOTUSMulticentre, controlled, randomized, investigator-blinded, comparative study of oral mesalazine 4g per day once daily versus 4g per day in two divided doses in patients with active ulcerative colitis. - MOTUS Patients with mild to moderate active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode
Product Name: Pentasa 2g sachet prolonged release granules (95%)
INN or Proposed INN: MESALAZINE
Ferring Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
398United Kingdom;Netherlands;Belgium;France
127EUCTR2008-004610-27-HU
(EUCTR)
26/02/200915/12/2008A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitisA double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis Mild to moderate active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: Dersalazine sodium
Product Code: UR-12746-S
INN or Proposed INN: dersalazine sodium
Trade Name: Lixacol
Product Name: Lixacol
INN or Proposed INN: Mesalazine
Trade Name: Lixacol
Product Name: Lixacol
INN or Proposed INN: mesalazine
Palau Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
90Phase 2Hungary;Belgium;Spain
128EUCTR2008-000045-59-BE
(EUCTR)
23/12/200822/09/2008Multicentre, controlled, randomized, investigator-blinded, comparitive study of oral Mesalazine 4 g per day Once daily versus 4 g per day in Two divided doses in patients with Active Ulcerative Colitis. - MOTUSMulticentre, controlled, randomized, investigator-blinded, comparitive study of oral Mesalazine 4 g per day Once daily versus 4 g per day in Two divided doses in patients with Active Ulcerative Colitis. - MOTUS Patients with mild to moderate ulcerative colitisProduct Name: Pentasa 2g sachet prolonged release granules (95%)
INN or Proposed INN: MESALAZINE
Ferring SASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
398United Kingdom;Netherlands;Belgium;France
129EUCTR2008-004610-27-BE
(EUCTR)
02/12/200824/07/2008A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitisA double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis Mild to moderate active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: Dersalazine sodium
Product Code: UR-12746-S
INN or Proposed INN: dersalazine sodium
Trade Name: Lixacol
Product Name: Lixacol
INN or Proposed INN: Mesalazine
Trade Name: Lixacol
Product Name: Lixacol
INN or Proposed INN: mesalazine
Palau Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
90Phase 2Hungary;Belgium;Spain
130NCT00808977
(ClinicalTrials.gov)
December 200815/12/2008A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative ColitisA Double-blind, Randomised, Placebo and Mesalazine Controlled Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Active ColitisUlcerative ColitisDrug: Dersalazine sodium;Drug: Mesalazine;Drug: PlaceboPalau Pharma S.A.NULLCompleted18 Years65 YearsBoth80Phase 2Belgium;Hungary;Slovakia;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131EUCTR2008-004610-27-ES
(EUCTR)
25/11/200826/09/2008Estudio fase II doble ciego, aleatorizado, controlado con placebo y mesalazina de seguridad y actividad de dersalazina en pacientes con colitis activa leve o moderada.A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitisEstudio fase II doble ciego, aleatorizado, controlado con placebo y mesalazina de seguridad y actividad de dersalazina en pacientes con colitis activa leve o moderada.A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis Colitis ulcerosa de leve a moderadaMild to moderate ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: Dersalazina sodica
INN or Proposed INN: dersalazine sodium
Trade Name: LIXACOL
Product Name: LIXACOL
INN or Proposed INN: MESALAZINA
Other descriptive name: MESALAZINE
Trade Name: LIXACOL
Product Name: LIXACOL
INN or Proposed INN: MESALAZINA
Other descriptive name: MESALAZINE
Palau Pharma S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2Hungary;Belgium;Spain
132NCT00737789
(ClinicalTrials.gov)
November 200819/8/2008Mesalazine 4g Once Daily Versus 4g in Two Divided Doses in Active Ulcerative Colitis.Multicentre, Controlled, Randomised, Investigator-Blinded, Comparative Study of Oral Mesalazine 4g Once Daily Versus Mesalazine 4g in Two Divided Doses in Patients With Active Ulcerative Colitis.Ulcerative ColitisDrug: Mesalazine slow-release granules;Drug: Mesalazine liquid enemaFerring PharmaceuticalsNULLCompleted18 YearsN/ABoth206Phase 3Belgium;France;Netherlands;United Kingdom
133EUCTR2008-000045-59-NL
(EUCTR)
06/10/200813/08/2008Multicentre, controlled, randomized, investigator-blinded, comparative study of oral Mesalazine 4g per day Once daily versus 4g per day in Two divided doses in patients with active Ulcerative colitiS - MOTUSMulticentre, controlled, randomized, investigator-blinded, comparative study of oral Mesalazine 4g per day Once daily versus 4g per day in Two divided doses in patients with active Ulcerative colitiS - MOTUS Patients with mild to moderate ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode
Product Name: Pentasa 2g sachet prolonged release granules (95%)
INN or Proposed INN: MESALAZINE
Ferring SASNULLNot RecruitingFemale: yes
Male: yes
398United Kingdom;Netherlands;Belgium;France
134EUCTR2008-000045-59-FR
(EUCTR)
04/06/200822/04/2008Multicentre, controlled, randomized, investigator-blinded, comparative study of oral Mesalazine 4g per day Once daily versus 4g per day in Two divided doses in patients with active Ulcerative colitiS - MOTUSMulticentre, controlled, randomized, investigator-blinded, comparative study of oral Mesalazine 4g per day Once daily versus 4g per day in Two divided doses in patients with active Ulcerative colitiS - MOTUS Patients with mild to moderate ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode
Product Name: Pentasa 2g sachet prolonged release granules (95%)
INN or Proposed INN: MESALAZINE
Ferring SASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
398United Kingdom;Netherlands;Belgium;France
135EUCTR2007-007928-18-DE
(EUCTR)
04/06/200812/11/2008Evaluation of efficacy and safety of the herbal drug Myrrhinil-Intest vs. mesalazine in maintaining clinical remission of ulcerative colitis - a 12-month, multicenter, randomized, prospective, double-blind, double-dummy, active-controlled and parallel group phase IV-trial - MIRCUEvaluation of efficacy and safety of the herbal drug Myrrhinil-Intest vs. mesalazine in maintaining clinical remission of ulcerative colitis - a 12-month, multicenter, randomized, prospective, double-blind, double-dummy, active-controlled and parallel group phase IV-trial - MIRCU ulcerative colitis patients in clinical remission
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Myrrhinil-Intest®
INN or Proposed INN: MATRICARIA FLOWER
Other descriptive name: MATRICARIA FLOWER
INN or Proposed INN: MYRRH
Other descriptive name: MYRRH
INN or Proposed INN: COFFEE COAL
Other descriptive name: COFFEE COAL
Trade Name: Salofalk® 500mg
INN or Proposed INN: MESALAZINE
REPHA GmbHNULLNot RecruitingFemale: yes
Male: yes
Phase 4-Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136EUCTR2007-004732-23-PL
(EUCTR)
05/05/200812/05/2008A MULTICENTER, RANDOMIZED, BLINDED, PLACEBO CONTROLLED, PARALLEL DESIGN, THREE-ARM, BIOEQUIVALENCE STUDY WITH CLINICAL ENDPOINTS COMPARING MESALAMINE DELAYED RELEASE TABLETS 400mg TO THE REFERENCE LISTED DRUG ASACOL® DELAYED RELEASE TABLETS 400mg IN PATIENTS WITH MILD TO MODERATELY ACTIVE ULCERATIVE COLITIS.)A MULTICENTER, RANDOMIZED, BLINDED, PLACEBO CONTROLLED, PARALLEL DESIGN, THREE-ARM, BIOEQUIVALENCE STUDY WITH CLINICAL ENDPOINTS COMPARING MESALAMINE DELAYED RELEASE TABLETS 400mg TO THE REFERENCE LISTED DRUG ASACOL® DELAYED RELEASE TABLETS 400mg IN PATIENTS WITH MILD TO MODERATELY ACTIVE ULCERATIVE COLITIS.) Mild to moderately active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
Product Name: Mesalamine
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
Product Name: Asacol Delayed-Release Tablets
INN or Proposed INN: MESALAZINE
EMET Pharmaceuticals, LLCNULLNot RecruitingFemale: yes
Male: yes
435Estonia;Latvia;Poland
137EUCTR2007-004732-23-LV
(EUCTR)
27/02/200828/02/2008A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative ColitisA Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis Mild to moderately active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Product Name: Mesalamine Delayed Release Tablets 400mg
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
Product Name: Asacol Delayed-Release Tablets
INN or Proposed INN: MESALAZINE
EMET Pharmaceuticals LLCNULLNot RecruitingFemale: yes
Male: yes
435Estonia;Latvia;Poland
138EUCTR2004-004184-29-NL
(EUCTR)
15/01/200817/10/2007A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
826Phase 3Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
139EUCTR2004-004184-29-PT
(EUCTR)
14/12/200711/10/2007A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
826Phase 3Hungary;Portugal;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
140EUCTR2004-004184-29-SE
(EUCTR)
22/11/200727/09/2007A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
830Phase 3Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141EUCTR2006-005377-22-LT
(EUCTR)
13/11/200714/08/2007Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UCDouble-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC Treatment of ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Salofalk 1000mg Granu-Stix
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
360Phase 3Czech Republic;Germany;Spain;Latvia;Poland;Lithuania
142EUCTR2006-005377-22-DE
(EUCTR)
23/10/200716/07/2007Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UCDouble-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC Treatment of ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Salofalk 1000mg Granu-Stix
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
360Phase 3Czech Republic;Poland;Spain;Lithuania;Latvia;Germany
143EUCTR2007-004732-23-EE
(EUCTR)
22/10/200723/10/2007A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative ColitisA Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis Mild to moderately active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Product Name: Mesalamine Delayed Release Tablets 400mg
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
Product Name: Asacol Delayed-Release Tablets
INN or Proposed INN: MESALAZINE
EMET Pharmaceuticals LLCNULLNot RecruitingFemale: yes
Male: yes
435Estonia;Latvia;Poland
144NCT00747110
(ClinicalTrials.gov)
October 20073/9/2008Budesonide Capsules Versus Mesalazine Granules in Active Ulcerative Colitis (UC)Double-blind, Double-dummy, Randomised, Multi-centre, Comparative Phase III Clinical Study on the Efficacy and Tolerability of an 8 Week Oral Treatment With 9 mg Budesonide or 3 g Mesalazine in Patients With Active Ulcerative ColitisColitis, UlcerativeDrug: budesonide;Drug: mesalazineDr. Falk Pharma GmbHNULLCompleted18 Years75 YearsBoth343Phase 3Germany
145EUCTR2006-005377-22-LV
(EUCTR)
27/09/200712/09/2007Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UCDouble-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC Treatment of ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Salofalk 1000mg Granu-Stix
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
360Phase 3Czech Republic;Germany;Spain;Latvia;Poland;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146EUCTR2006-005377-22-CZ
(EUCTR)
17/09/200714/09/2007Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UCDouble-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC Treatment of ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Salofalk 1000mg Granu-stix®
INN or Proposed INN: MESALAZINE
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
360Phase 3Germany;Czech Republic;Spain;Latvia;Poland;Lithuania
147EUCTR2006-005377-22-SK
(EUCTR)
14/09/200716/04/2008Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UCDouble-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC Treatment of ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Salofalk 1000mg Granu-Stix®
INN or Proposed INN: MESALAZINE
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
360Phase 3Czech Republic;Slovakia;Poland;Spain;Lithuania;Latvia;Germany
148EUCTR2006-004162-13-DE
(EUCTR)
27/02/200706/10/2006Randomized, double-blind, placebo-controlled phase II pilot study of the impact of mesalazine enemas on the mucosal gut flora in patients with inflammatory bowel disease - Impact of mesalazine vs placebo on mucosal gut flora in IBD patientsRandomized, double-blind, placebo-controlled phase II pilot study of the impact of mesalazine enemas on the mucosal gut flora in patients with inflammatory bowel disease - Impact of mesalazine vs placebo on mucosal gut flora in IBD patients Active inflammatory bowel disease, i.e. either left-sided ulcerative colitis or Crohn´s Disease (Colon) with signs of inflammation within 40 cm ab ano.
MedDRA version: 8.1;Level: LLT;Classification code 10021972;Term: Inflammatory bowel disease
Trade Name: Salofalk 4g/60ml Klysma
INN or Proposed INN: MESALAZINE
Charité Universitätsmedizin, Campus Charité MitteNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Germany
149EUCTR2006-001782-42-HU
(EUCTR)
20/12/200616/08/2006Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo.Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. Active left-sided, mild to moderate ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: CB-01-05-MMX
Product Code: CB-01-05-MMX
Other descriptive name: PARNAPARIN SODIUM
Cosmo Technologies LtdNULLNot RecruitingFemale: yes
Male: yes
120Hungary;United Kingdom;Italy
150EUCTR2006-002036-25-GB
(EUCTR)
09/11/200615/02/2012Epidermal growth factor enemas versus mesalazine enemas for the treatment of mild-to-moderate active left-sided ulcerative colitis or proctitis - EGF enema in UCEpidermal growth factor enemas versus mesalazine enemas for the treatment of mild-to-moderate active left-sided ulcerative colitis or proctitis - EGF enema in UC Ulcerative ColitisProduct Name: Epidermal growth factor enema
Product Code: EGF enema
INN or Proposed INN: Epidermal growth factor
Trade Name: Pentasa enema
Product Name: Pentasa
INN or Proposed INN: mesalazine enema
University Hospitals of Leicester NHS TrustNULLNot RecruitingFemale: yes
Male: yes
50Phase 3United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151EUCTR2006-001782-42-IT
(EUCTR)
03/11/200620/12/2006Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin CB-01-05-MMXTM , administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. - NDEfficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin CB-01-05-MMXTM , administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. - ND Patients with mild to moderate active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Product Name: CB-01-05-MMX COSMO TECHNOLOGIES LTDNULLNot RecruitingFemale: yes
Male: yes
120Hungary;United Kingdom;Italy
152EUCTR2006-001782-42-GB
(EUCTR)
17/10/200629/09/2006Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo.Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. Active left-sided, mild to moderate ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Cosmo Technologies LtdNULLNot Recruiting Female: yes
Male: yes
120Phase 2Hungary;Italy;United Kingdom
153ChiCTR-TRC-08000048
2006-10-012008-01-17A multicenter, double-blind, randomized controlled trial: Traditional Chinese Medicine treatment for ulcerative colitisIntervention and efficacy evaluation study of Traditional Chinese Medicine for ulcerative colitis Ulcerative colitisControlled group:Take mesalazine 1g Qid in active stage. Sustain the treatment for another week after the symptoms relieve. Then take 0.5g Tid and adjust the dosage according to the condition. The treatment lasts for 6 months.;Experimental group:Take the intestine-clearing and dissipating dampness formula 2 times a day in the 1st stage. Enema is given once a day for 12 days. Take health-supporting and intestine-clearing formula for spleen and stomach deficiency 2 times a day. The treatment lasts for 6 months;The Affiliated Hospital of Nanjing University of Traditional Chinese MedicineNULLCompleted1865BothControlled group:112;Experimental group:112;I (Phase 1 study)China
154NCT00708656
(ClinicalTrials.gov)
October 20068/4/2008The Colitis Once Daily Asacol StudyA Randomized, Single-Blind Study to Assess Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily Versus Divided Doses 3 Times Daily for 12 Months in Maintenance of Remission of Ulcerative Colitis.Ulcerative ColitisDrug: mesalazine (Asacol®)Cardiff and Vale University Health BoardProcter and GambleCompleted18 YearsN/AAll213Phase 3United Kingdom
155EUCTR2006-001310-32-LT
(EUCTR)
17/07/200615/05/2006A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND IIIA double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Product Name: Asacol 800 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Product Name: Asacol 400 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Procter & Gamble Technical Centres LimitedNULLNot RecruitingFemale: yes
Male: yes
770Hungary;Czech Republic;Estonia;Latvia;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156EUCTR2006-001310-32-HU
(EUCTR)
29/06/200623/05/2006A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND IIIA double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III Ulcerative Colitis
MedDRA version: 8.1;Classification code 10009900
Product Name: Asacol 800 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Product Name: Asacol 400 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Procter & Gamble Technical Centres LimitedNULLNot RecruitingFemale: yes
Male: yes
770Hungary;Czech Republic;Estonia;Latvia;Lithuania
157EUCTR2006-001310-32-CZ
(EUCTR)
26/06/200617/05/2006A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND IIIA double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III Ulcerative Colitis
MedDRA version: 8.1;Classification code 10009900
Product Name: Asacol 800 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Product Name: Asacol 400 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Procter & Gamble Technical Centres LimitedNULLNot RecruitingFemale: yes
Male: yes
770Hungary;Czech Republic;Estonia;Latvia;Lithuania
158EUCTR2006-001310-32-EE
(EUCTR)
16/06/200627/04/2006A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND IIIA double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III Ulcerative Colitis
MedDRA version: 8.1;Classification code 10009900
Product Name: Asacol 800 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Product Name: Asacol 400 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Procter & Gamble Technical Centres LimitedNULLNot RecruitingFemale: yes
Male: yes
770Hungary;Czech Republic;Estonia;Latvia;Lithuania
159EUCTR2006-001310-32-LV
(EUCTR)
28/04/200622/08/2006A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - Ascend IIIA double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - Ascend III Ulcerative ColitisProduct Name: Asacol 800mg tablet
INN or Proposed INN: mesalazine
Product Name: Asacol 400mg tablet
INN or Proposed INN: mesalazine
Procter & Gamble Technical Centres LimitedNULLNot RecruitingFemale: yes
Male: yes
470Hungary;Czech Republic;Estonia;Latvia;Lithuania
160EUCTR2005-002784-91-GB
(EUCTR)
06/02/200624/11/2005A Randomized, Multicentre, Parallel Group Single-Blind Study to Assess the Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily versus Divided Doses Three Times Daily for 12 Months in the Maintenance of Remission of Ulcerative Colitis. - CODA study (Colitis Once Daily Asacol)A Randomized, Multicentre, Parallel Group Single-Blind Study to Assess the Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily versus Divided Doses Three Times Daily for 12 Months in the Maintenance of Remission of Ulcerative Colitis. - CODA study (Colitis Once Daily Asacol) Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain.Cardiff and Vale NHS TrustNULLNot Recruiting Female: yes
Male: yes
630Phase 3United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161EUCTR2004-001216-31-SI
(EUCTR)
22/12/200526/10/2005Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UCDouble-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC Therapy of active ulcerative colitis
MedDRA version: 7.1;Level: LLT;Classification code 10058816
Trade Name: Salofalk® 1000mg Granu-Stix®
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 1500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
320Estonia;Czech Republic;Hungary;Slovenia;Lithuania;Latvia;Germany
162EUCTR2004-001218-15-SI
(EUCTR)
22/12/200526/10/2005Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UCDouble-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC Maintenance therapy of ulcerative colitisTrade Name: Salofalk® 500mg Granu-Stix®
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 1500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 750mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 250mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
510Estonia;Hungary;Slovenia;Lithuania;Latvia;Germany
163JPRN-C000000288
2005/12/0121/11/2005Z-206 Phase III Clinical Trial- Investigation on the remission-inducing effect in patients with ulcerative colitis in active phase - Patients with ulcerative colitis in active phaseZ-206 2.4g/day dose group: Two Z-206 400mg tablets, 1 tablet of Z-206 placebo tablet, 3 tablets of Pentasa placebo tablet per time (total 6 tablets).
3 times a day (t.i.d.) after each meal for 8 weeks.
Z-206 3.6g/day dose group: Three tablets of Z-206 400mg tablet, 3 tablets of Pentasa placebo tablet per time (total 6 tablets).
3 times a day (t.i.d.) after each meal for 8 weeks.
Mesalazine group: Three tablets of Pentasa 250 mg tablet and 3 tablets of Z-206 placebo tablet per time (total 6 tablets).
3 times a day (t.i.d.) after each meal for 8 weeks.
Placebo group: Three tablets of Z-206 placebo tablet and 3 tablets of Pentasa placebo tablet per time (total 6 tablets).
3 times a day (t.i.d.) after each meal for 8 weeks.
Zeria Pharmaceutical Co.,LTD.NULLComplete: follow-up complete16years-old64years-oldMale and Female210Phase 3Japan
164JPRN-C000000289
2005/12/0121/11/2005Z-206 Phase III Clinical Trial- Investigation on the remission-maintaining effect in patients with ulcerative colitis in remission phase - Patients with ulcerative colitis in remission phase.Z-206 group : Two Z-206 400 mg tablets, 3 tablets of Pentasa placebo tablet per time (total 5 tablets).
3 times a day (t.i.d.) after each meal for 48 weeks.
Mesalazine group: Three tablets of Pentasa 250 mg tablet and 2 tablets of Z-206 placebo tablet per time (total 5 tablets).
3 times a day (t.i.d.) after each meal for 48 weeks.
Zeria Pharmaceutical Co.,LTD.NULLComplete: follow-up complete16years-old64years-oldMale and Female120Phase 3Japan
165EUCTR2004-004565-15-FI
(EUCTR)
26/08/200528/04/2005Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUMPentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM Ulcerative collitis (UC)
MedDRA version: 4.1;Level: PT;Classification code 10009900
Trade Name: Pentasa
Product Name: Pentasa
INN or Proposed INN: mesalazine
Other descriptive name: 5-AminoSalicylic Acid
Trade Name: NA
Product Name: Pentasa prolonged release granules 2g
INN or Proposed INN: mesalazine
Ferring BVNULLNot RecruitingFemale: yes
Male: yes
360Finland;Germany;Czech Republic;Denmark;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166EUCTR2004-001216-31-CZ
(EUCTR)
17/08/200517/08/2005Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UCDouble-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC Therapy of active ulcerative colitis
MedDRA version: 7.1;Level: LLT;Classification code 10058816
Trade Name: Salofalk® 1000mg Granu-Stix®
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 1500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
320Hungary;Germany;Czech Republic;Estonia;Latvia;Lithuania
167EUCTR2004-001216-31-SK
(EUCTR)
28/07/200523/05/2005Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UCDouble-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC Therapy of active ulcerative colitis
MedDRA version: 7.1;Level: LLT;Classification code 10058816
Trade Name: Salofalk® 1000mg Granu-Stix®
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 1500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
320Phase 3Estonia;Czech Republic;Hungary;Slovenia;Slovakia;Lithuania;Latvia;Germany
168EUCTR2004-001216-31-HU
(EUCTR)
28/07/200520/06/2005Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UCDouble-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC Therapy of active ulcerative colitis
MedDRA version: 7.1;Level: LLT;Classification code 10058816
Trade Name: Salofalk® 1000mg Granu-Stix®
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 1500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
320Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania
169EUCTR2004-001216-31-LV
(EUCTR)
25/07/200525/07/2005Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UCDouble-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC Therapy of active ulcerative colitis
MedDRA version: 7.1;Level: LLT;Classification code 10058816
Trade Name: Salofalk® 1000mg Granu-Stix®
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 1500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
320Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania
170EUCTR2004-000734-36-CZ
(EUCTR)
13/07/200508/10/2004A phase III, randomized, multi-center, open-label, 12 to 14 months extension study to evaluate the safety and tolerability of SPD476 (mesalazine) give once daily vs. twice daily for the maintenance of ulcerative colitis in remission.A phase III, randomized, multi-center, open-label, 12 to 14 months extension study to evaluate the safety and tolerability of SPD476 (mesalazine) give once daily vs. twice daily for the maintenance of ulcerative colitis in remission. Subject not in remission of Ulcerative Colitis (UC-DAI score of >1) at the End of Study/Early Withdrawal Visit of Study 301 or 302.Subject in remission of UC (UC-DAI<1 with a score of 0 for rectal bleeding and stool frequency, and at least a 1 point reduction in the sigmoidocsopy score from Study 301 or 302 baseline) at the End of Study Visit of Study 301 or 302, or at the end of the Acute Phase of this studyProduct Name: Mesalazine
Product Code: SPD476
INN or Proposed INN: Mesalazinum
Other descriptive name: 5-amino salicylic acid (5-ASA)
Shire Pharmaceutical Development Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
125Phase 3Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171NCT00449722
(ClinicalTrials.gov)
July 200520/3/2007OD vs. TID Dosing With Mesalazine Granules in Active Ulcerative ColitisDouble-blind, Double-dummy, Randomised, Multicentre, Comparative Study of the Efficacy and Tolerability of Once Daily 3.0 g Mesalazine Granules Versus Three Times Daily 1.0 g Mesalazine Granules in Patients With Active Ulcerative ColitisUlcerative ColitisDrug: mesalazineDr. Falk Pharma GmbHNULLCompleted18 Years75 YearsBoth380Phase 3Germany
172EUCTR2004-001218-15-EE
(EUCTR)
07/06/200527/04/2005Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UCDouble-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC Maintenance therapy of ulcerative colitisTrade Name: Salofalk® 500mg Granu-Stix®
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 1500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 750mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 250mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
600Hungary;Germany;Estonia;Latvia;Lithuania
173EUCTR2004-004184-29-DE
(EUCTR)
06/06/200501/03/2005A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitisProduct Name: None given
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
410Phase 3Portugal;Hungary;Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Spain;Sweden
174EUCTR2004-001216-31-LT
(EUCTR)
06/06/200528/04/2005Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UCDouble-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC Therapy of active ulcerative colitis
MedDRA version: 7.1;Level: LLT;Classification code 10058816
Trade Name: Salofalk® 1000mg Granu-Stix®
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 1500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
320Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania
175EUCTR2004-004565-15-CZ
(EUCTR)
03/06/200513/04/2005Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUMPentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM Ulcerative collitis (UC)
MedDRA version: 4.1;Level: PT;Classification code 10009900
Trade Name: Pentasa sachet 1g
Product Name: Pentasa
INN or Proposed INN: mesalazine
Other descriptive name: 5-AminoSalicylic Acid
Product Name: Pentasa prolonged release granules 2g
INN or Proposed INN: mesalazine
Ferring BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Finland;Germany;Czech Republic;Denmark;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176EUCTR2004-004184-29-GB
(EUCTR)
31/05/200523/02/2005A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Shire Pharmaceutical Development LtdNULLNot Recruiting Female: yes
Male: yes
826Phase 3Portugal;Czech Republic;Hungary;Spain;Denmark;Netherlands;Germany;United Kingdom;Sweden
177EUCTR2004-001218-15-LV
(EUCTR)
30/05/200530/05/2005Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UCDouble-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC Maintenance therapy of ulcerative colitisTrade Name: Salofalk® 500mg Granu-Stix®
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 1500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 750mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 250mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
510Hungary;Germany;Estonia;Latvia;Lithuania
178EUCTR2004-001216-31-DE
(EUCTR)
30/05/200504/04/2005Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UCDouble-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC Therapy of active ulcerative colitis
MedDRA version: 7.1;Level: LLT;Classification code 10058816
Trade Name: Salofalk® 1000mg Granu-Stix®
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 1500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
320Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania
179EUCTR2004-004565-15-SE
(EUCTR)
24/05/200509/03/2005Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUMPentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM Ulcerative collitis (UC)
MedDRA version: 4.1;Level: PT;Classification code 10009900
Trade Name: Pentasa Sachet 1g
Product Name: Pentasa Sachet 1 g
INN or Proposed INN: mesalazine
Other descriptive name: 5-AminoSalicylic Acid
Product Name: Pentasa Sachet 2 g
INN or Proposed INN: mesalazine
Ferring BVNULLNot RecruitingFemale: yes
Male: yes
360Finland;Germany;Czech Republic;Denmark;Norway;Sweden
180EUCTR2004-004184-29-ES
(EUCTR)
05/05/200503/04/2006A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis.A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. Ulcerative colitis
MedDRA version: 3.2;Level: LLT;Classification code 10045365
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
410Phase 3Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181NCT00746447
(ClinicalTrials.gov)
May 20053/9/2008Once Daily (OD) Versus Three Times Daily (TID) Dosing With Mesalazine Granules for Prevention of Recurrence of Ulcerative Colitis (UC)Double-blind, Double-dummy, Randomised, Multicentre, 12-months, Comparative Study of the Efficacy and Tolerability of Once Daily 3.0 g Mesalazine Granules vs. Once Daily 1.5 g Mesalazine Granules vs. Three Times Daily 0.5 g Mesalazine Granules for Maintenance of Remission in Patients With Ulcerative ColitisColitis, Ulcerative;RecurrenceDrug: mesalamine granulesDr. Falk Pharma GmbHNULLCompleted18 Years75 YearsBoth648Phase 3Germany
182EUCTR2004-004077-29-SK
(EUCTR)
25/04/200501/02/2005A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative ColitisA Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain.Product Name: RDP58
Product Code: RDP58
INN or Proposed INN: Delmitide acetate
Other descriptive name: SF257 C59
Product Name: mesalazine
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic Acid
Procter & Gamble PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Czech Republic;Slovakia;Lithuania;Germany;United Kingdom
183EUCTR2004-004184-29-CZ
(EUCTR)
13/04/200511/04/2005A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets.
Product Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
826Phase 3Portugal;Hungary;Germany;United Kingdom;Czech Republic;Netherlands;Denmark;Spain;Sweden
184EUCTR2004-004565-15-NO
(EUCTR)
06/04/200514/02/2005Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUMPentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM Ulcerative collitis (UC)
MedDRA version: 4.1;Level: PT;Classification code 10009900
Trade Name: Pentasa sachet 1g
Product Name: Pentasa
INN or Proposed INN: mesalazine
Other descriptive name: 5-AminoSalicylic Acid
Trade Name: NA
Product Name: Pentasa prolonged release granules 2g
INN or Proposed INN: mesalazine
Ferring BVNULLNot RecruitingFemale: yes
Male: yes
360Finland;Germany;Czech Republic;Denmark;Norway;Sweden
185EUCTR2004-001218-15-DE
(EUCTR)
04/04/200510/12/2004Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UCDouble-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC Maintenance therapy of ulcerative colitisINN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 1500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 750mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 250mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
510Hungary;Germany;Estonia;Latvia;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186NCT00151892
(ClinicalTrials.gov)
April 20057/9/2005Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative ColitisA Phase III, Randomized Multi-centre, Double-blind, Parallel Group, Active Comparator Study to Compare the Efficacy and Safety of SPD476 (Mesalazine)2.4g/Day Once Daily With Asacol 1.6g/Day Twice Daily in the Maintenance of Remission in Patients With Ulcerative ColitisUlcerative ColitisDrug: SPD476;Drug: AsacolShireNULLCompleted18 YearsN/AAll829Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;Chile;Czech Republic;Denmark;France;Germany;Hungary;India;Korea, Republic of;Mexico;Netherlands;New Zealand;Peru;Poland;Portugal;Romania;Russian Federation;Singapore;South Africa;Spain;Sweden;Taiwan;United Kingdom
187EUCTR2004-004565-15-DK
(EUCTR)
31/03/200524/02/2005Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUMPentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM Ulcerative collitis (UC)
MedDRA version: 4.1;Level: PT;Classification code 10009900
Product Name: Pentasa Sachet
INN or Proposed INN: mesalazine
Other descriptive name: 5-AminoSalicylic Acid
Product Name: Pentasa Sachet
INN or Proposed INN: mesalazine
Ferring BVNULLNot RecruitingFemale: yes
Male: yes
360Finland;Germany;Czech Republic;Denmark;Norway;Sweden
188EUCTR2004-004184-29-HU
(EUCTR)
30/03/200510/02/2005A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets.
Product Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
826Phase 3Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
189EUCTR2004-001218-15-SK
(EUCTR)
24/03/200502/02/2005Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UCDouble-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC Maintenance therapy of ulcerative colitisTrade Name: Salofalk® 500mg Granu-Stix®
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 1500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 750mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 250mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Estonia;Hungary;Slovenia;Slovakia;Lithuania;Latvia;Germany
190EUCTR2004-001218-15-HU
(EUCTR)
17/03/200504/02/2005Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UCDouble-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC Maintenance therapy of ulcerative colitisTrade Name: Salofalk® 500mg Granu-Stix®
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 1500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 750mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 250mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
510Hungary;Germany;Estonia;Latvia;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191EUCTR2004-004077-29-GB
(EUCTR)
18/02/200523/02/2005A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative ColitisA Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain.Product Name: RDP58
Product Code: RDP58
INN or Proposed INN: Delmitide acetate
Other descriptive name: SF257 C59
Product Name: mesalazine
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic Acid
Procter & Gamble Technical Centres LtdNULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Lithuania;Germany;United Kingdom
192EUCTR2004-004077-29-LT
(EUCTR)
09/02/200522/12/2004A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative ColitisA Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain.Product Name: RDP58
Product Code: RDP58
INN or Proposed INN: Delmitide acetate
Other descriptive name: SF257 C59
Product Name: mesalazine
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic Acid
Procter & Gamble PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
250United Kingdom;Czech Republic;Germany;Lithuania
193EUCTR2004-001218-15-LT
(EUCTR)
09/02/200527/12/2004Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UCDouble-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC Maintenance therapy of ulcerative colitisTrade Name: Salofalk® 500mg Granu-Stix®
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 1500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 750mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 250mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
600Hungary;Germany;Estonia;Latvia;Lithuania
194EUCTR2004-004077-29-DE
(EUCTR)
04/02/200522/12/2004A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative ColitisA Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain.Product Name: RDP58
Product Code: RDP58
INN or Proposed INN: Delmitide acetate
Other descriptive name: SF257 C59
Product Name: mesalazine
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic Acid
Procter & Gamble PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
250United Kingdom;Czech Republic;Germany;Lithuania
195EUCTR2004-004077-29-CZ
(EUCTR)
03/02/200503/02/2005A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative ColitisA Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain.Product Name: RDP58
Product Code: RDP58
INN or Proposed INN: Delmitide acetate
Other descriptive name: SF257 C59
Product Name: mesalazine
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic Acid
Procter & Gamble PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
250United Kingdom;Germany;Czech Republic;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196EUCTR2004-001216-31-EE
(EUCTR)
11/01/200520/09/2005Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UCDouble-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC Therapy of active ulcerative colitis
MedDRA version: 7.1;Level: LLT;Classification code 10058816
Trade Name: Salofalk® 1000mg Granu-Stix®
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 1500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
320Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania
197EUCTR2004-000916-25-IT
(EUCTR)
28/09/200418/05/2005A PHASE III PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUPS, STUDY, TO ASSESS THE EFFECT OF 5-ASA MMx 1.2 g Tablets IN MAINTENANCE OF REMISSION OF LEFT-SIDED ULCERATIVE COLITISA PHASE III PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUPS, STUDY, TO ASSESS THE EFFECT OF 5-ASA MMx 1.2 g Tablets IN MAINTENANCE OF REMISSION OF LEFT-SIDED ULCERATIVE COLITIS TREATMENT OF ULCERATIVE COLITIS IN ACTIVE PHASE AND IN THE MAINTENANCE OF CLINICAL REMISSION
MedDRA version: 6.1;Level: PT;Classification code 10021972
Product Name: 5-ASA MMx
INN or Proposed INN: Mesalazine
GIULIANINULLNot RecruitingFemale: yes
Male: yes
Phase 3Italy
198EUCTR2004-000733-12-CZ
(EUCTR)
14/07/200401/07/2004A phase III, randomized, multi-center, double-blind, parallel-group, placebo controlled study to evaluate the safety and efficacy of SPD476 (mesalazine) given twice daily (2.4g/day) versus SPD476 given as a single dose (4.8g/day) in subject with acute mild to moderate ulcerative colitis.A phase III, randomized, multi-center, double-blind, parallel-group, placebo controlled study to evaluate the safety and efficacy of SPD476 (mesalazine) given twice daily (2.4g/day) versus SPD476 given as a single dose (4.8g/day) in subject with acute mild to moderate ulcerative colitis. Subjects who have newly diagnosed or have a diagnosis of relapsing (relapses1 and a Physician Global Assessment of <2). The original diagnosis of UC must be established by sigmoidoscopy, colonoscopy, or barium enema and have compatible histology.Product Name: Mesalazine
Product Code: SPD476
INN or Proposed INN: Mesalazinum
Other descriptive name: 5-amino salicylic acid (5-ASA)
Shire Pharmaceutical Development IncNULLNot RecruitingFemale: yes
Male: yes
255Phase 3Czech Republic
199NCT00548574
(ClinicalTrials.gov)
December 200323/10/2007Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative ColitisA Phase III, Randomized, Multi-Centre, Double-blind, Double Dummy, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to ASACOL 0.8g Three Times Daily, in Subjects With Mild to Moderate Ulcerative ColitisUlcerative ColitisDrug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine;Drug: MesalazineShireNULLCompleted18 YearsN/ABoth343Phase 3Belgium
200NCT00151944
(ClinicalTrials.gov)
November 20037/9/2005Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis.A Phase III, Randomized, Multi-center, Open-label, 12 to 14 Month Extension Study to Evaluate the Safety and Tolerability of SPD476 (Mesalazine) Given Once Daily vs. Twice Daily for the Maintenance of Ulcerative Colitis in Remission.Colitis, UlcerativeDrug: SPD476 (mesalazine)ShireNULLCompleted18 YearsN/ABoth400Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201NCT00503243
(ClinicalTrials.gov)
September 200316/7/2007Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative ColitisA Phase III, Randomized, Multi-Centre, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) Versus SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative ColitisColitis, UlcerativeDrug: Delayed and extended release mesalazineShireNULLCompleted18 YearsN/ABoth280Phase 3United States
202NCT00545389
(ClinicalTrials.gov)
February 200316/10/2007Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476A Phase II, Randomized, Multi-Centre, Double-Blind, Parallel-Group, Dose-Ranging, Exploratory Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476 (Mesalazine) Once DailyColitis, UlcerativeDrug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazineShireNULLCompleted18 YearsN/ABoth38Phase 2Belgium
203EUCTR2007-005702-49-PL
(EUCTR)
17/06/2009A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy ofAsacol® (1.2 to 4.8 g/day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents with Mildly-to-Moderately Active Ulcerative Colitis. - CAMP IIA Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy ofAsacol® (1.2 to 4.8 g/day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents with Mildly-to-Moderately Active Ulcerative Colitis. - CAMP II Mildly-to-Moderately Active Ulcerative Colitis in Children and Adolescents
MedDRA version: 11.0;Level: LLT;Classification code 10045365;Term:
Trade Name: Asacol
Product Name: Asacol
Product Code: NA
INN or Proposed INN: MESALAZINE
Procter & Gamble PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Poland
204JPRN-JapicCTI-090967
09/12/2009PS-QD Phase3 Clinical Study -Investigation to find new dosage and administration of mesalazine for the treatment of patients with Ulcerative Colitis in remission phase.-PS-QD Phase3 Clinical Study -Investigation to find new dosage and administration of mesalazine for the treatment of patients with Ulcerative Colitis in remission phase.- ulcerative colitisIntervention name : PS-QD
Dosage And administration of the intervention : Mesalazine at the dose 1500mg/day or 2250mg/day is administered once a day or three times a day.
Control intervention name : null
Kyorin Pharmaceutical Co.,LTDNULL1564BOTHPhase 3NULL
205EUCTR2006-005377-22-PL
(EUCTR)
14/02/2008Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UCDouble-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC Treatment of ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis
Dr. Falk Pharma GmbHNULLNot Recruiting Female: yes
Male: yes
360Phase 3Czech Republic;Slovakia;Spain;Poland;Lithuania;Latvia;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206JPRN-JapicCTI-111421
PS-SP PhaseIII Clinical Study; Investigation to find new formulation of mesalazine for treatment of patients with active Ulcerative Colitis.PS-SP PhaseIII Clinical Study; Investigation to find new formulation of mesalazine for treatment of patients with active Ulcerative Colitis. Ulcerative ColitisIntervention name : PS-SP
Dosage And administration of the intervention : PS-SP suppository 1g or placebo is administered rectally once a day.
Control intervention name : null
Kyorin Pharmaceutical Co.,LTDNULL1574BOTHPhase 3NULL
207JPRN-JapicCTI-121943
30/08/2012Phase II Study of Z-206Phase II Study of Z-206 Ulcerative colitisIntervention name : Z-206
INN of the intervention : Mesalazine
Dosage And administration of the intervention : oral
Zeria Pharmaceutical Co., Ltd.Kyowa Hakko Kirin Co., Ltd.BOTHPhase 2NULL
208JPRN-JapicCTI-101144
25/05/2010Phase II/III induction study of AJG501 in patients with active ulcerative colitisPhase II/III induction study of AJG501 in patients with active ulcerative colitis Ulcerative colitisIntervention name : AJG501
Dosage And administration of the intervention : oral
Control intervention name : Mesalazine tablet
Dosage And administration of the control intervention : oral
Ajinomoto Pharmaceuticals Co., Ltd.NULL1664BOTHPhase 2;Phase 3NULL
209EUCTR2004-004565-15-DE
(EUCTR)
15/09/2005Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUMPentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM Ulcerative collitis (UC)
MedDRA version: 4.1;Level: PT;Classification code 10009900
Product Name: Pentasa
INN or Proposed INN: mesalazine
Other descriptive name: 5-AminoSalicylic Acid
Product Name: Pentasa prolonged release granules 2g
INN or Proposed INN: mesalazine
Ferring BVNULLNot RecruitingFemale: yes
Male: yes
360Finland;Czech Republic;Germany;Denmark;Norway;Sweden