Once Daily Versus Conventional Dosing of Asacol in the Maintenance of Quiescent Ulcerative Colitis
Completed · Phase 3
Conditions studied: Ulcerative Colitis
In brief
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 regimen is easiest to follow. Once daily dosing of Asacol is experimental, and has not been approved by the FDA. Dosing as three times daily is FDA approved. This research is being done because the researchers want to learn what the best methods are for keeping ulcerative colitis inactive, and which way of taking Asacol is most helpful to subjects in continuing to take a medication to control their ulcerative colitis.
Key facts
- Study ID
- NCT00343850
- Run by
- University of Chicago
- People needed
- 30
- Starts
- 2006-09-01
- Expected to finish
- 2007-03-01
- Last updated by the study team
- 2013-01-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- The University of Chicago — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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