A Double-Blind, Randomized, 6-Week, Parallel-Group Design Clinical Trial to Assess Safety and Efficacy of Asacol 4.8 g/Day (800 mg Tablet) Versus Asacol 2.4 g/Day (400 mg Tablet) for the Treatment of Moderately Active Ulcerative Colitis

Date de début de l'étude : 1 septembre 2000

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.