Official Title: “Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2003

Intervention(s) in this Clinical Trial

• Drug: Asacol (mesalamine)
  • tablets, 4.8 g/day for 6 weeks
• Drug: asacol 400 mg (mesalamine)
  • tablets, 2.4 g/day for 6 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Asacol (2.4 g/day)
• Experimental: 2
  • Asacol (800 mg/day)

Primary Measures

• patients who at the end of 6 weeks were classified as a success
  • Time Frame: 6 weeks
    Safety Issue?: No

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 pregancy test, or lactating.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Procter and Gamble

Overall Clinical Trial Officials and Contacts

Piotr Krzeski, MD Study Director Procter and Gamble  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00073021

Study ID Number: 200082

ClinicalTrials.gov Identifier: NCT00073021

Health Authority: United States: Food and Drug Administration