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

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.