Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)

Condition(s) targeted: Ulcerative Colitis

Intervention: mesalamine (Drug); mesalamine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Procter and Gamble

Official(s) and/or principal investigator(s):
Jeffery Kralstein, MD, Study Director, Affiliation: Procter and Gamble

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

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

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

Primary outcome: the proportion of patients in each treatment group who improved from baseline at Week 6

Secondary outcome: 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.

Detailed description: 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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Research Site, Birmingham, Alabama, United States

Research Site, Anaheim, California, United States

Research Site, Sacramento, California, United States

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Research Facility, Poughkeepsie, New York, United States

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Starting date: February 2001
Ending date: February 2003
Last updated: February 11, 2008