Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis

• Status: Completed
• Trial end date: 2003-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a prospective clinical study to evaluate the safety and efficacy of two different doses of Asacol for the treatment of moderately active ulcerative colitis. In addition, a new tablet formulation will be evaluated at one of the two doses.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Warner Chilcott
• Treatments: Mesalamine

Criteria

Inclusion Criteria:

• male or female between 18 and 75 years of age;

• have a confirmed diagnosis of ulcerative colitis with the extent varying from proctitis to pancolitis;

• currently demonstrating moderately active disease

Exclusion Criteria:

Patients will be excluded from admission to the study if they have/are:

• a history of allergy or hypersensitivity to salicylates or aminosalicylates;

• a history of extensive small bowel resection (>1/2 the length of the small intestine) causing short bowel syndrome;

• current renal or hepatic disease;

• participated in any drug or device clinical study within 30 days of entry;

• currently enrolled in any other clinical study;

• received any oral, intravenous, intramuscular, or rectally administered corticosteroids within 1 month prior to the Baseline Visit;

• received any other topical rectal therapy during the week prior to the Screening Visit;

• received immunomodulatory therapy including, but not limited to, 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate within 3 months prior to the Baseline Visit;

• received a dose of mesalamine-containing compound by any route from which more than 1.6 g/day of mesalamine was available within 1 week prior to the Screening Visit (NOTE: 4 g/day of sulfasalazine and 4.5 g/day of balsalazide are equivalent to 1.6 g/day of mesalamine);

• received antibiotics, other than topical antibiotics, within 1 week prior to the Screening Visit;

• received aspirin (except for cardioprotective reasons up to a maximum dose of 325 mg/day) or NSAIDs within 1 week prior to the Baseline Visit;

• if female, positive pregnancy test, or lactating.