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

Completed · Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID: NCT00073021
Run by: Warner Chilcott
People needed: 386
Starts: 2000-09-01
Expected to finish: 2003-09-01
Last updated by the study team: 2015-06-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

AGMG Clinical Research — Anaheim, California, United States
Research Site — Los Angeles, California, United States
Community Clinical Trials — Orange, California, United States
AGMG Clinical Research — Orange, California, United States
Research Site — Sacramento, California, United States
Sharp Rees-Stealy Medical Group — San Diego, California, United States
Research Site — Arvada, Colorado, United States
Research Site — Englewood, Colorado, United States
Center for Medical Research, LLC — Manchester, Connecticut, United States
Center for GI Disorders — Hollywood, Florida, United States
Research Site — Maitland, Florida, United States
Advanced Gastroenterology Associates — Palm Harbor, Florida, United States
Research Site — Zephyrhills, Florida, United States
Southeast Research Associates — Marietta, Georgia, United States
University of Chicago Medical Center — Chicago, Illinois, United States
GI Research — Metairie, Louisiana, United States
Louisiana Research Center — Shreveport, Louisiana, United States
Digestive Disorders Associates — Annapolis, Maryland, United States
Research Site — Baltimore, Maryland, United States
Digestive Disease Associates — Baltimore, Maryland, United States
Metropolitan Gastroenterology Group — Chevy Chase, Maryland, United States
Brigham & Women's Hospital — Boston, Massachusetts, United States
Henry Ford Hospital — Detroit, Michigan, United States
Mayo Clinic — Rochester, Minnesota, United States
Mayo Clinic Scottsdale — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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