Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University of Washington Procter and Gamble |
---|---|
Information provided by: | University of Washington |
ClinicalTrials.gov Identifier: | NCT00194818 |
We, the investigators at University of Washington, plan on evaluating the effect of open label Asacol at a dose of 4.8 grams/day divided BID (twice per day) or TID (three times per day) on its ability to induce remission in patients with mild to moderately active ulcerative colitis. We hypothesize that both regimens will have the same efficacy and no difference in side effects.
Condition | Intervention | Phase |
---|---|---|
Ulcerative Colitis |
Drug: Asacol (mesalamine) |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Open Label Safety and Efficacy Trial of Twice Daily Dosing of Asacol vs. Three Times Per Day Dosing for the Induction of Remission in Active Ulcerative Colitis |
Enrollment: | 7 |
Study Start Date: | June 2003 |
Study Completion Date: | August 2007 |
Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Asacol 6 tablets BID (4.8 grams/day)
|
Drug: Asacol (mesalamine)
Available in 400mg delayed release tablet. Randomized to either 6 tablets BID (4.8 g/day) or 4 tablets TID (4.8 g/day) for a total of 12 weeks.
|
2: Active Comparator
Asacol 4 tablets TID (4.8 grams/day)
|
Drug: Asacol (mesalamine)
Available in 400mg delayed release tablet. Randomized to either 6 tablets BID (4.8 g/day) or 4 tablets TID (4.8 g/day) for a total of 12 weeks.
|
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Washington | |
University of Washington Medical Center | |
Seattle, Washington, United States, 98195 |
Principal Investigator: | Scott D Lee, MD | University of Washington |
Responsible Party: | University of Washington ( Scott D. Lee, MD ) |
Study ID Numbers: | 04-1694-A 01 |
Study First Received: | September 15, 2005 |
Last Updated: | February 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00194818 |
Health Authority: | United States: Institutional Review Board |
Digestive System Diseases Mesalamine Gastrointestinal Diseases Ulcer Colonic Diseases |
Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |
Anti-Inflammatory Agents Pathologic Processes Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs |
Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents Pharmacologic Actions |