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

Information source: Warner Chilcott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ulcerative Colitis

Intervention: mesalamine (Drug); mesalamine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Warner Chilcott

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Percentage of Patients Classified as Treatment Success at Week 6, ITT Population

Secondary outcome:

Percentage of Patients Classified as Treatment Success at Week 3, ITT Population

Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 3, All Randomized Patients

Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 6, All Randomized Patients

Stool Frequency Improvement at Week 3, All Randomized Patients (Percentage)

Stool Frequency Improvement at Week 6, All Randomized Patients (Percentage)

Rectal Bleeding Improvement at Week 3, All Randomized Patients (Percentage)

Rectal Bleeding Improvement at Week 6, All Randomized Patients (Percentage)

Improvement in Patient's Functional Assessment (PFA) at Week 3, All Randomized Patients (Percentage)

Improvement in Patient's Functional Assessment (PFA) at Week 6, All Randomized Patients (Percentage)

Improvement in Patient's Sigmoidoscopy Assessment Score at Week 3, All Randomized Patients (Percentage)

Improvement in Patient's Sigmoidoscopy Assessment Score at Week 6, All Randomized Patients (Percentage)

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 resection

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, Ft Myers, Florida, United States

Research Site, Hollywood, Florida, United States

Research Site, Jupiter, Florida, United States

Research Site, Miami, Florida, United States

Research Facility, Atlanta, Georgia, United States

Research Facility, Decatur, Georgia, United States

Research Site, Arlington Heights, Illinois, United States

Research Site, Moline, Illinois, United States

Research Site, Rockford, Illinois, United States

Research Site, Wichita, Kansas, United States

Research Site, Metairie, Louisiana, United States

Research Site, Baltimore, Maryland, United States

Research Site, Laurel, 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 Site, Great Neck, New York, United States

Research Site, Pomona, New York, United States

Research Facility, Poughkeepsie, 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, Memphis, Tennessee, United States

Research Facility, Nashville, Tennessee, United States

Research Site, Ft Worth, Texas, United States

Research Site, Houston, Texas, United States

Research Site, San Antonio, Texas, United States

Research Site, Burlington, Vermont, United States

Research Site, Charlottesville, Virginia, United States

Research Facility, Falls Church, Virginia, United States

Research Site, Norfolk, Virginia, United States

Research Site, Tacoma, Washington, United States

Research Site, Milwaukee, Wisconsin, United States

Additional Information

Starting date: February 2001
Last updated: September 14, 2011

Page last updated: August 23, 2015

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