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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01257399
• Date of registration: 08/12/2010
• Prospective Registration: No
• Primary sponsor: Tillotts Pharma AG
• Public title: Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase
• Scientific title: Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase
• Date of first enrolment: November 2010
• Target sample size: 251
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01257399
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

China

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 64 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Ulcerative Colitis in Remission

Intervention(s)

Drug: Asacol®

Drug: Mesalazine

Primary Outcome(s)

Rate of non-emergence of bloody stool [Time Frame: Week 48]

Secondary Outcome(s)

1) Period of non-emergence of bloody stool, 2) Rate of non-recurrence, 3) Period of non-recurrence, 4) Reduction of UC-DAI score [Time Frame: Week 48]

Secondary ID(s)

03010302A

2007L03525

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Zeria Pharmaceutical