Status:
COMPLETED
A Double Blind Study for the Treatment of Acute Ulcerative Colitis
Lead Sponsor:
Warner Chilcott
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
A Double-blind, Randomized, 6-week, Parallel-group Design Clinical trial to assess the Safety and Efficacy of Asacol 4.8 g/day (800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mg mesalamine tab...
Detailed Description
This is a double-blind, randomized, multi-center, multi-national, active-control study in patients who are experiencing a moderately active flare of UC. Patients will be randomly assigned to receive e...
Eligibility Criteria
Inclusion
- Patients 18-75 years with a confirmed diagnosis of moderately active flare of ulcerative colitis.
- Female patients need to be postmenopausal or using adequate contraception.
Exclusion
- Patients with isolated proctitis
- Patients with comorbidities or an investigative or commercialized treatments confounding interpretation of study results or compromising patients' safety in the trial.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
772 Patients enrolled
Trial Details
Trial ID
NCT00350415
Start Date
June 1 2006
End Date
May 1 2007
Last Update
April 17 2013
Active Locations (135)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Facility
Alabaster, Alabama, United States, 35007
2
Research Facility
Birmingham, Alabama, United States, 35209
3
Research Facility
Tucson, Arizona, United States, 85712
4
Research Facility
Fayetteville, Arkansas, United States, 72703