97. 潰瘍性大腸炎
[臨床試験数:2,269,薬物数:1,331(DrugBank:241),標的遺伝子数:114,標的パスウェイ数:181

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.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
41 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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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
2NCT04133194
(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
3EUCTR2019-002070-31-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
4NCT03804931
(ClinicalTrials.gov)
January 20, 20196/1/2019Fecal Microbiota Transplantation for Ulcerative ColitisEfficacy and Safety of Fecal Microbiota Transplantation for Ulcerative ColitisUlcerative Colitis;Fecal Microbiota TransplantationProcedure: Fecal microbiota transplantation;Procedure: Infusion of Saline;Drug: 5-Aminosalicylic acid(5-ASA) and/or PrednisoneGuangzhou First People's HospitalNULLRecruiting18 Years65 YearsAll120Phase 2;Phase 3China
5JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT02665845
(ClinicalTrials.gov)
June 13, 201625/1/2016Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone (for Ulcerative Colitis).Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis: A Protocol of a Multi-center Prospective Randomized Investigator Blinded Trial.Ulcerative ColitisDrug: 5-ASA;Drug: CorticosteroidsCentre Hospitalier Universitaire de Saint EtienneNULLRecruiting18 YearsN/AAll160Phase 3France;Greece;Israel;Italy;Korea, Republic of;Serbia
7JPRN-UMIN000019310
2015/11/0101/11/2015Randomized controlled study for concomitant use of 5-aminosalicylic acid suppository with increased dose of oral 5-aminosalicylic acid for moderate to severe patients with ulcerative colitis ulcerative colitisArm A: Increase of oral 5-ASA (oral administration of 5-ASA in a maximum dose for 8 weeks)
Arm B: Increase of oral 5-ASA and addition of 5-ASA suppository (oral administration of 5-ASA in a maximum dose for 8 weeks and topical administration of 1 g of 5-ASA suppository for 4 weeks)
Department of Gastroenterology and Hepatology, Osaka University Graduate School of MedicineNULLComplete: follow-up complete16years-oldNot applicableMale and Female90Not selectedJapan
8JPRN-UMIN000018075
2015/06/2625/06/2015Significance of optimal therapy for ulcerative colitis patients with clinical remission who have colonic active lesions Ulcerative colitisnormal dosage of 5-ASA (dosage for maintenance therapy) to maximaum dosage of 5-ASA
no optimized therapy
Center for Diagnostic and Therapeutic Endoscopy,Keio UniversityNULLComplete: follow-up complete20years-oldNot applicableMale and Female100Not selectedJapan
9JPRN-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
10NCT01941589
(ClinicalTrials.gov)
September 201330/8/2013Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative ColitisCombination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis.Ulcerative ColitisDrug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone;Drug: corticosteroids onlySheba Medical CenterNULLRecruiting18 YearsN/AAll160Phase 4China;France;Greece;Israel;Italy;Korea, Republic of;Serbia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT04032652
(ClinicalTrials.gov)
December 20124/12/2012Use of Rectal Dialysis Technique to Measure Rectal 5-ASA Levels in Healthy Volunteers Receiving AsacolMeasurement of Rectal Levels of 5-aminosalicylic Acid (5-ASA) Using a Novel In-vivo Rectal Dialysis Technique in Healthy Volunteers on AsacolUlcerative ColitisProcedure: Rectal dialysis;Drug: Rectal dialysisNorthShore University HealthSystemNULLTerminated18 Years45 YearsAll2Phase 2NULL
12EUCTR2011-005115-82-LT
(EUCTR)
12/09/201224/05/2012An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen Ulcerative Colitis
MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide-MMX®
INN or Proposed INN: BUDESONIDE
Santarus, Inc.NULLNot RecruitingFemale: yes
Male: yes
500United States;Hungary;Estonia;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
13EUCTR2011-005115-82-LV
(EUCTR)
15/06/201221/05/2012An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide-MMX®
INN or Proposed INN: BUDESONIDE
Santarus, Inc.NULLNot RecruitingFemale: yes
Male: yes
500United States;Hungary;Estonia;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
14EUCTR2011-005115-82-EE
(EUCTR)
05/06/201209/05/2012An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide-MMX®
INN or Proposed INN: BUDESONIDE
Santarus, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500United States;Hungary;Czech Republic;Estonia;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
15EUCTR2011-005115-82-BG
(EUCTR)
11/05/201211/04/2012An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen 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 Name: Budesonide-MMX®
INN or Proposed INN: BUDESONIDE
Santarus, Inc.NULLNot RecruitingFemale: yes
Male: yes
500United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2011-005115-82-CZ
(EUCTR)
18/04/201208/02/2012An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen Ulcerative Colitis
MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide-MMX®
INN or Proposed INN: BUDESONIDE
Santarus, Inc.NULLNot RecruitingFemale: yes
Male: yes
500United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
17EUCTR2011-005115-82-PL
(EUCTR)
10/04/201216/03/2012An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen Ulcerative Colitis
MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide-MMX®
INN or Proposed INN: BUDESONIDE
Santarus, Inc.NULLNot RecruitingFemale: yes
Male: yes
500United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
18EUCTR2011-005115-82-HU
(EUCTR)
26/03/201207/02/2012An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide-MMX®
INN or Proposed INN: BUDESONIDE
Santarus, Inc.NULLNot RecruitingFemale: yes
Male: yes
500United States;Estonia;Czech Republic;Hungary;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
19NCT01532648
(ClinicalTrials.gov)
January 27, 201213/12/2011Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients With Active, Mild or Moderate Ulcerative Colitis Not Adequately Controlled on a Background Oral 5-ASA RegimenUlcerative ColitisDrug: Budesonide MMX®;Drug: Placebo;Drug: 5-ASABausch Health Americas, Inc.NULLCompleted18 Years75 YearsAll510Phase 3United States;Bulgaria;Canada;Czechia;Estonia;Hungary;Latvia;Lithuania;Poland;Russian Federation;Ukraine;Czech Republic
20JPRN-UMIN000003785
2010/07/0101/07/2010Remission maintenance treatment of ulcerative colitis with tacrolimus in azathioprine-intolerant patients: a randomized comparative trial of 5-aminosalicylic acid (5-ASA) monotherapy versus 5-ASA and tacrolimus combination therapy. Ulcerative colitis5-aminosalicylic acid monotherapy arm:
5-aminosalicylic acid is administered to subjects during the study period (for 48 weeks).

5-aminosalicylic acid monotherapy and tacrolimus arm:
5-aminosalicylic acid is administered to subjects during the study period (for 48 weeks). Tacrolimus is administered to subjects for 12 weeks after the start of protocol treatment as a rule.
Department of Internal medicine, Division of Lower Gastroenterology, Hyogo College of MedicineNULLComplete: follow-up complete16years-old65years-oldMale and Female80Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2009-010921-38-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
22EUCTR2009-010065-23-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
23EUCTR2008-007292-25-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
24NCT00603733
(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
25EUCTR2006-001782-42-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2006-001782-42-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
27EUCTR2006-001782-42-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
28EUCTR2006-001310-32-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
29EUCTR2006-001310-32-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
30EUCTR2006-001310-32-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2006-001310-32-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
32NCT00408174
(ClinicalTrials.gov)
May 20064/12/2006Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative ColitisA Multicenter, Randomized, Double-Blind, Actively-Controlled Trial to Evaluate the Safety and Efficacy of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium 3.3 g Bid Versus Mesalamine (5-ASA) as Asacol® 0.8 g Tid in Mildly to Moderately Active Ulcerative ColitisInflammatory Bowel Disease;Ulcerative ColitisDrug: Balsalazide disodiumBausch Health Americas, Inc.NULLCompleted18 YearsN/AAll400Phase 3United States
33EUCTR2004-000734-36-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
34EUCTR2004-001677-26-IT
(EUCTR)
06/06/200515/02/2006Nolpitantium Besylate in patients with mild to moderate Ulcerative Colitis a double-blind, placebo controlled efficacy and safety, 8-week studyNolpitantium Besylate in patients with mild to moderate Ulcerative Colitis a double-blind, placebo controlled efficacy and safety, 8-week study Patients with 5-aminosalicylic 5-ASA or sulphasalazine resistant ulcerative colitis
MedDRA version: 6.1;Level: PT;Classification code 10009900
Product Name: Nolpitantium Besylate
Product Code: SR140333B
SANOFI-SYNTHELABONULLNot RecruitingFemale: yes
Male: yes
300Hungary;Czech Republic;Estonia;Spain;Italy;Sweden
35EUCTR2004-001677-26-EE
(EUCTR)
23/03/200523/03/2005Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICENolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis.
MedDRA version: 7.0;Level: LLT;Classification code 10045365
Product Name: Nolpitantium besylate
Product Code: SR140333B
INN or Proposed INN: Nolpitantium besylate
Sanofi-Synthelabo RechercheNULLNot RecruitingFemale: yes
Male: yes
300Hungary;Czech Republic;Estonia;Spain;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2004-001677-26-SE
(EUCTR)
07/02/200523/12/2004Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICENolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis.
MedDRA version: 7.0;Level: LLT;Classification code 10045365
Product Name: Nolpitantium besylate
Product Code: SR140333B
INN or Proposed INN: Nolpitantium besylate
Sanofi-Synthelabo RechercheNULLNot RecruitingFemale: yes
Male: yes
300Hungary;Czech Republic;Estonia;Spain;Italy;Sweden
37EUCTR2004-001677-26-HU
(EUCTR)
25/01/200503/11/2004Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICENolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis.
MedDRA version: 7.0;Level: LLT;Classification code 10045365
Product Name: Nolpitantium besylate
Product Code: SR140333B
INN or Proposed INN: Nolpitantium besylate
Sanofi-Synthelabo RechercheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Hungary;Czech Republic;Estonia;Spain;Italy;Sweden
38EUCTR2004-001677-26-ES
(EUCTR)
14/01/200501/06/2005Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study.Estudio doble ciego, controlado con placebo de 8 semanas de duración, de eficacia y seguridad de besilato de nolpitantium en pacientes con colitis ulcerosa leve a moderada. - NICENolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study.Estudio doble ciego, controlado con placebo de 8 semanas de duración, de eficacia y seguridad de besilato de nolpitantium en pacientes con colitis ulcerosa leve a moderada. - NICE Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis.
MedDRA version: 7.0;Level: LLT;Classification code 10045365
Product Name: Nolpitantium besylate
Product Code: SR140333B
INN or Proposed INN: Nolpitantium besylate
Sanofi-Synthelabo RechercheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Hungary;Czech Republic;Estonia;Spain;Italy;Sweden
39EUCTR2004-000916-25-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
40EUCTR2004-000733-12-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2004-001677-26-CZ
(EUCTR)
09/03/200410/02/2005Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICENolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis.
MedDRA version: 7.0;Level: LLT;Classification code 10045365
Product Name: Nolpitantium besylate
Product Code: SR140333B
INN or Proposed INN: Nolpitantium besylate
sanofi-aventis recherche & developpementNULLNot RecruitingFemale: yes
Male: yes
300Hungary;Czech Republic;Estonia;Spain;Italy;Sweden