Ascend III: A Double-blind, Randomized, 6 week parallel group clinical trial to study the safety and efficacy of Asacol 4.8g/day vs. Asacol 2.4 g/d for the treatment of moderately active ulcerative colitis.
IRB#: 0607M88751
Trial Status: Open for enrollment
Phase: III
Sponsor: Procter & Gamble Pharmaceuticals
Why is this study being done?
This research study is being done to find out if 4.8g/day of Asacol (mesalamine) per day is more effective than 2.4g/day of Asacol in patients with moderately active ulcerative colitis.
Who is eligible to participate in the study?
Patients with moderately active ulcerative colitis extending beyond 15 cm (more involvement than the rectum) who are on less than 1.6grams per day of mesalamine and have not received an immunomodulator (eg. 6MP) or a biologic agent (eg. Remicade) within the last 90 days.
Minimum age: 18 years
Maximum age: 75 years
What is involved in the study?
The study involves taking a medication three times a day for a six week period. As part of screening, you will be asked to undergo a flexible-sigmoidoscopy, blood work, stool studies, a urine pregnancy test and a physical exam. If you are eligible, you will undergo a baseline, 3 week and 6 week visit for medical history and assessment. On the final visit, you will need to complete a physical exam and sigmoidoscopy.
How long will the study run?
You will be in the study for up to 6 weeks.
Who can I contact to find out more about this trial?
If you are interested in participating in this study or would like additional information, please contact Kathy Duderstadt at (612) 626-3421.
What are the locations of this trial?
University of Minnesota Medical Center, Fairview – Minneapolis, Minnesota
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