Status:
COMPLETED
Once Daily Versus Conventional Dosing of Asacol in the Maintenance of Quiescent Ulcerative Colitis
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Procter and Gamble
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if taking Asacol once a day is as effective as taking Asacol twice or three times a day in keeping ulcerative colitis inactive, and to determine which dosing ...
Detailed Description
Hypothesis: Asacol taken once a day is equally effective (non-inferior) as conventional (twice or three times a day) dosing at maintaining remission in quiescent ulcerative colitis. Specific Aims: 1...
Eligibility Criteria
Inclusion
- Adult patients over the age of 18 followed at the University of Chicago Outpatient Gastroenterology Clinic will be eligible. Patients must have documentation of ulcerative colitis by standard criteria, and be in remission for at least 4 months prior to study entry. Remission for this study will be defined clinically, as the absence of all of the following: blood in the stools, urgency, or cramping. Patients must be taking a regimen of Asacol (Asacol, Procter and Gamble, Cincinnati Ohio) for maintenance of quiescent disease
Exclusion
- Exclusion criteria include documented disease activity in the past four months, hospitalization or steroid use for disease activity in the previous 4 months, or the use of other immunomodulators to induce remission. Patients with a history of other diarrheal illnesses such as diarrhea-predominant Irritable Bowel Syndrome, C difficile colitis, use of known diarrheal drugs will also be excluded.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00343850
Start Date
September 1 2006
End Date
March 1 2007
Last Update
January 10 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of Chicago
Chicago, Illinois, United States, 60637