Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase

Phase 3

Completed

• Conditions: Ulcerative Colitis in Remission
• Interventions: Drug: Asacol®; Drug: Mesalazine

• Registration Number: NCT01257399
• Lead Sponsor: Tillotts Pharma AG

Brief Summary

To demonstrate that import Mesalazine (ASACOL®) is non-inferior to the reference drug, marketed Mesalazine, regarding the primary endpoint (rate of non-emergence of bloody stool), in patients with Ulcerative Colitis in remission, treated for 48 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-12-08
• Study First Submitted QC: 2010-12-08
• Study First Posted: 2010-12-09
• Primary Completion: 2013-01
• Study Completion: 2013-03
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-03
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

Inclusion Criteria

• Patients with ulcerative colitis in remission who are defined to show an Ulcerative Colitis-Disease Activity Index (UC-DAI) score of 2 or less and a bloody stool score of 0.

Exclusion Criteria

• Patients who take adrenal corticosteroid (oral formulation, enemas, suppository, agents for hemorrhoidal disease, injectable solution) within 14 days before start of administration of clinical study drug.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Asacol®	Asacol®	Import Mesalazine
Mesalazine	Mesalazine	Marketed Mesalazine

Primary Outcome Measures

Name	Time	Method
Rate of non-emergence of bloody stool	Week 48

Secondary Outcome Measures

Name	Time	Method
1) Period of non-emergence of bloody stool, 2) Rate of non-recurrence, 3) Period of non-recurrence, 4) Reduction of UC-DAI score	Week 48

Trial Locations

Locations (1)

Shanghai Hospital; 🇨🇳 Shanghai, China