Asacol Dosing Study for Active Ulcerative Colitis

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborator: Procter and Gamble
• Treatments: Mesalamine

Criteria

Inclusion Criteria:

• Ability to provide consent

• Age older than 18 years and younger than 80 years

• Confirmed diagnosis of ulcerative colitis by endoscopic or radiologic evaluation at least 4 weeks prior to randomization

• Active ulcerative colitis at time of screening (UCAI > 4 <12)

• Receiving stable doses of medications at least 4 weeks prior to receiving the first dose of study drug

• Agree to use of an adequate form of contraception throughout the study period for sexually active males and females of child-bearing potential

• Able to comply with protocol requirements

• Subjects may not be on any form of corticosteroids, immunosuppressives or anti-tumor necrosis factor (TNF) therapy

Exclusion Criteria:

• Critically ill

• Risk factors for toxicity to Asacol, including pre-existing hepatic disease (biopsy-proven cirrhosis, chronic active hepatitis, or serum aspartate aminotransferase, bilirubin, or alkaline phosphatase concentrations at least twice the upper limit of normal except for patients with the diagnosis of primary sclerosing cholangitis, a liver disease which occurs in patients with ulcerative colitis), renal dysfunction (serum creatinine concentration greater than 1.7 mg per deciliter [150mmol per liter]). Patients with primary sclerosing cholangitis (PSC), a liver disease that is often associated with ulcerative colitis, will be allowed to participate in the study if their liver function tests have been stable for at least 4 weeks. Previous studies have not shown any detrimental effects of Asacol on PSC.

• Systemic infections

• Pregnancy or a desire to become pregnant

• High alcohol consumption (more than seven drinks per week)

• Known hypersensitivity to Asacol

• Estimated survival of less than one year

• Unwilling to comply with the protocol