Official Title: “A Double-Blind, Randomized, 6 Week, Parallel-Group Design Clinical Trial in Patients With Mildly to Moderately Active Ulcerative Colitis to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day”

The purpose of this study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) versus Asacol 2.4 g/day (400 mg tablet

Study Type: Interventional

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

Study Primary Completion Date: February 2003

This study is designed to evaluate the safety and efficacy of 4.8 g/day using 800 mg Asacol tablets as compared to 2.4g/day using 400 mg Asacol tablets in newly- and previously-diagnosed patients who are experiencing a flare-up of mildly to moderately active ulcerative colitis.

Intervention(s) in this Clinical Trial

• Drug: mesalamine
  • mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
• Drug: mesalamine
  • mesalamine 4.8 g/day (800 mg tablet) for 6 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
• Experimental: 2
  • mesalamine 4.8 g/day (800 mg tablet) for 6 weeks

Primary Measures

• the proportion of patients in each treatment group who improved from baseline at Week 6
  • Time Frame: 6 weeks
    Safety Issue?: Yes

Secondary Measures

• patient improvement at Week 3, sigmoidoscopic and clinical improvement (stool frequency, rectal bleeding, PGA, and PFA), and quality of life (Inflammatory Bowel Disease Questionnaire) at Weeks 3 and 6.
  • Time Frame: 3 and 6 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• confirmed diagnosis of ulcerative colitis

Exclusion Criteria:

• a history of allergy or hypersensitivity to salicylates or aminosalicylates;
• a history of extensive small bowel resectio

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Procter and Gamble

Overall Clinical Trial Officials and Contacts

Jeffery Kralstein, MD Study Director Procter and Gamble  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00577473

Study ID Number: 2000083

ClinicalTrials.gov Identifier: NCT00577473

Health Authority: United States: Food and Drug Administration