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

Information source: Procter and Gamble
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

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

Summary

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

Clinical Details

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.

Eligibility

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

Locations and Contacts

Research Site, Birmingham, Alabama, United States

Research Site, Anaheim, California, United States

Research Site, Sacramento, California, United States

Research Site, San Francisco, California, United States

Research Site, Denver, Colorado, United States

Research Facility, Golden, Colorado, United States

Research Site, Bridgeport, Connecticut, United States

Research Site, Miami, Florida, United States

Research Site, Hollywood, Florida, United States

Research Site, Ft Myers, Florida, United States

Research Site, Jupiter, Florida, United States

Research Facility, Decatur, Georgia, United States

Research Facility, Atlanta, Georgia, United States

Research Site, Arlington Heights, Illinois, United States

Research Site, Rockford, Illinois, United States

Research Site, Moline, Illinois, United States

Research Site, Wichita, Kansas, United States

Research Site, Metairie, Louisiana, United States

Research Site, Laurel, Maryland, United States

Research Site, Baltimore, Maryland, United States

Research Site, Detroit, Michigan, United States

Research Site, New Brunswick, New Jersey, United States

Research Site, Somerville, New Jersey, United States

Research Facility, Poughkeepsie, New York, United States

Research Site, Great Neck, New York, United States

Research Site, Pomona, New York, United States

Research Site, Raleigh, North Carolina, United States

Research Site, Winston-Salem, North Carolina, United States

Research Site, Cincinnati, Ohio, United States

Research Site, Tulsa, Oklahoma, United States

Research Site, Philadelphia, Pennsylvania, United States

Research Site, Pittsburgh, Pennsylvania, United States

Research Site, Charleston, South Carolina, United States

Research Facility, Nashville, Tennessee, United States

Research Facility, Memphis, Tennessee, United States

Research Site, Houston, Texas, United States

Research Site, San Antonio, Texas, United States

Research Site, Ft Worth, Texas, United States

Research Site, Burlington, Vermont, United States

Research Site, Charlottesville, Virginia, United States

Research Site, Norfolk, Virginia, United States

Research Facility, Falls Church, Virginia, United States

Research Site, Tacoma, Washington, United States

Research Site, Milwaukee, Wisconsin, United States

Additional Information

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

Page last updated: June 20, 2008

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