Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01257386
• Date of registration: 08/12/2010
• Prospective Registration: No
• Primary sponsor: Tillotts Pharma AG
• Public title: Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis
• Scientific title: Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis
• Date of first enrolment: November 2010
• Target sample size: 251
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01257386
• 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 (UC) at active phase who are defined to show
Ulcerative Colitis-Disease Activitiy Index (UC-DAI) score of 3 or higher but 8 or
less, and bloody stool score of 1 or higher

Exclusion Criteria:

- Patients with serious or higher according to diagnostic critera of seriousness and
patients with chronic persistent type and with acute serious type in the
classification by clinical course



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

Health Condition(s) or Problem(s) studied

Active Ulcerative Colitis

Intervention(s)

Drug: Asacol®

Drug: Mesalazine

Primary Outcome(s)

Reduction degree of UC-DAI [Time Frame: Week 8]

Secondary Outcome(s)

1) Reduction degree of score of each UC-DAI item 2) Remission rate 3) Effective rate [Time Frame: Week 8]

Secondary ID(s)

03010301A

2007L03525

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Zeria Pharmaceutical