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

Warner Chilcott

Status and phase

Completed

Phase 3

Conditions

Ulcerative Colitis

Treatments

Drug: Asacol 800 mg (mesalamine)

Drug: Asacol 400 mg (mesalamine)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00073021

2000082

Details and patient eligibility

About

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.

Enrollment

386 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.