Pentasa    (DrugBank: -)

2 diseases
IDDisease name (Link within this page)Number of trials
96Crohn disease15
97Ulcerative colitis29

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.
15 / 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
1JPRN-UMIN000015770
2014/09/0101/12/2014Randomized double-blind multicenter study for anti-inflammatory effects of highly bioavailable curcumin on Crohn's disease.Randomized double-blind multicenter study for anti-inflammatory effects of highly bioavailable curcumin on Crohn's disease. - Exploratory study for effects of highly bioavailable curcumin on Crohn's disease. Crohn's disease (180 <= CDAI < 450)CDAI: Crohn's disease Activity IndexStandard therapy for Crohn's disease (Pentasa 3 g/day)
Patients take curcumin or placebo
Hamamatsu South Hospital, Centre for Gastroenterology and Inflammatory Bowel Disease ResearchNULLComplete: follow-up complete20years-old70years-oldMale and Female30Not selectedJapan
2NCT00862121
(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
3NCT00245505
(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
4EUCTR2008-002100-26-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
5EUCTR2008-002100-26-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
6EUCTR2008-002100-26-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
7EUCTR2008-002100-26-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
8EUCTR2008-002100-26-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
9EUCTR2008-002100-26-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
10JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11JPRN-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
12NCT00225810
(ClinicalTrials.gov)
October 200522/9/2005A Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tablets in Children With Crohn´s DiseaseMulticentre, Controlled, Randomised, Open, Cross-over Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tbl. 500 mg in Children With Crohn´s DiseaseCrohn's DiseaseDrug: Crohn's DiseaseFerring PharmaceuticalsNULLCompleted8 Years18 YearsBoth50Phase 4Czech Republic
13EUCTR2005-002472-15-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
14NCT00167882
(ClinicalTrials.gov)
July 20059/9/2005The Influence of 5–Aminosalicylates on Thiopurine Metabolite LevelsCrohn's Disease;Ulcerative Colitis;Inflammatory Bowel DiseaseDrug: 5-aminosalicylate (Pentasa, Ferring)VU University Medical CenterNULLCompleted18 Years70 YearsBoth24Phase 4Netherlands
15EUCTR2014-004132-20-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.
29 / 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
1NCT04499495
(ClinicalTrials.gov)
November 30, 202031/7/2020Assessment of 5-Aminosalicylic Acid Prescription Patterns and Treatment Outcomes in Patients With Ulcerative Colitis in KoreaA Retrospective Study to Assess 5-Aminosalicylic Acid Prescription Patterns and Treatment Outcomes in Patients With Ulcerative Colitis in KoreaUlcerative ColitisOther: PENTASA (mesalamine/ 5-Aminosalicylic acid (5-ASA)Ferring PharmaceuticalsNULLNot yet recruiting15 YearsN/AAll15000NULL
2EUCTR2015-002558-11-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
3EUCTR2015-002557-35-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
4EUCTR2015-002558-11-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
5EUCTR2015-002557-35-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2015-002558-11-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
7EUCTR2015-002557-35-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
8NCT02368743
(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
9NCT02368717
(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
10NCT02261636
(ClinicalTrials.gov)
January 20157/10/2014Induction and Maintenance of Remission With Pentasa as Ulcerative Colitis TreatmentUlcerative ColitisDrug: mesalazineFerring PharmaceuticalsNULLCompleted18 Years70 YearsAll150Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT01517607
(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
12NCT01201122
(ClinicalTrials.gov)
September 201012/9/2010Once Versus Twice Daily Mesalamine to Induce Remission in Pediatric Ulcerative ColitisMulti Center Ulcerative Colitis Pediatric Pentasa Intervention Trial (MUPPIT). A Randomized, Single-blinded, Controlled, Parallel, Induction Therapy With Once vs. Twice Daily Dosing of Pentasa in Pediatric UC.Mild to Moderate Ulcerative ColitisDrug: MesalamineWolfson Medical CenterNULLCompleted6 Years18 YearsBoth86Phase 4Israel
13EUCTR2009-010065-23-DE
(EUCTR)
17/08/200914/04/2009Conventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIXConventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIX Active Moderate to Severe Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
Trade Name: Remicade
INN or Proposed INN: infliximab
Other descriptive name: 100
Trade Name: Pentasa 500 mg Retardtabletten
Product Name: 5-Aminosalicylic acid (5-ASA)
INN or Proposed INN: 5-Aminosalicylic acid
Trade Name: Imurek 25mg Filmtabletten
INN or Proposed INN: azathioprine
Trade Name: Imurek 50mg Filmtabletten
INN or Proposed INN: azathioprine
Trade Name: Decortin H 1 mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 5mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 10mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 20mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 50 mg
INN or Proposed INN: prednisolone
Essex Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
Phase 3Germany
14EUCTR2008-000045-59-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
15EUCTR2008-000045-59-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2008-000045-59-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
17EUCTR2008-000045-59-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
18NCT00603733
(ClinicalTrials.gov)
October 200716/1/2008Canadian Active & Maintenance Modified Pentasa StudyA Multicentre, Randomised, Double-blind, Non-inferiority Trial Comparing the Efficacy and Safety of a New Modified Oral Extended Release Pentasa® (Mesalamine) 500 mg Tablet to the Currently Marketed Pentasa® (Mesalamine) 500 mg Tablet in Subjects With Active Mild to Moderate Ulcerative Colitis Treated With 4 g/Day for 8 Weeks and in Maintenance of Remission of Ulcerative Colitis in Subjects Treated With 2 g/Day for 24 WeeksActive Ulcerative Colitis;Remission of Ulcerative ColitisDrug: 5-ASA (5-Aminosalicylate)Ferring PharmaceuticalsNULLCompleted18 Years75 YearsAll288Phase 3Canada
19EUCTR2006-002036-25-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
20JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21JPRN-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
22EUCTR2004-004565-15-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
23NCT00167882
(ClinicalTrials.gov)
July 20059/9/2005The Influence of 5–Aminosalicylates on Thiopurine Metabolite LevelsCrohn's Disease;Ulcerative Colitis;Inflammatory Bowel DiseaseDrug: 5-aminosalicylate (Pentasa, Ferring)VU University Medical CenterNULLCompleted18 Years70 YearsBoth24Phase 4Netherlands
24EUCTR2004-004565-15-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
25EUCTR2004-004565-15-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT00209300
(ClinicalTrials.gov)
May 200513/9/2005Pentasa Once Daily in Ulcerative Colitis for Maintenance of RemissionPentasa Once Daily in Ulcerative Colitis for Maintenance of Remission. A European Multi-centre Investigator Blinded Randomized Controlled Study of Pentasa Sachet Comparing One Gram Twice With Two Grams Once DailyUlcerative ColitisDrug: PentasaFerring PharmaceuticalsNULLCompleted18 YearsN/ABoth362Phase 3Belgium;Czech Republic;Denmark;Finland;Germany;Netherlands;Norway;Sweden
27EUCTR2004-004565-15-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
28EUCTR2004-004565-15-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
29EUCTR2004-004565-15-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