Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I) - Full Text View

Sponsor:	Procter and Gamble
Information provided by:	Procter and Gamble
ClinicalTrials.gov Identifier:	NCT00577473

Purpose

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

Condition	Intervention	Phase
Ulcerative Colitis	Drug: mesalamine	Phase III

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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Mesalamine

U.S. FDA Resources

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:

the proportion of patients in each treatment group who improved from baseline at Week 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Enrollment:	308
Study Start Date:	February 2001
Study Completion Date:	February 2003
Primary Completion Date:	February 2003 (Final data collection date for primary outcome measure)

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

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577473

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Locations

United States, Alabama
Research Site
Birmingham, Alabama, United States
United States, California
Research Site
Anaheim, California, United States
Research Site
Sacramento, California, United States
Research Site
San Francisco, California, United States
United States, Colorado
Research Site
Denver, Colorado, United States
Research Facility
Golden, Colorado, United States
United States, Connecticut
Research Site
Bridgeport, Connecticut, United States
United States, Florida
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
United States, Georgia
Research Facility
Decatur, Georgia, United States
Research Facility
Atlanta, Georgia, United States
United States, Illinois
Research Site
Arlington Heights, Illinois, United States
Research Site
Rockford, Illinois, United States
Research Site
Moline, Illinois, United States
United States, Kansas
Research Site
Wichita, Kansas, United States
United States, Louisiana
Research Site
Metairie, Louisiana, United States
United States, Maryland
Research Site
Laurel, Maryland, United States
Research Site
Baltimore, Maryland, United States
United States, Michigan
Research Site
Detroit, Michigan, United States
United States, New Jersey
Research Site
New Brunswick, New Jersey, United States
Research Site
Somerville, New Jersey, United States
United States, New York
Research Facility
Poughkeepsie, New York, United States
Research Site
Great Neck, New York, United States
Research Site
Pomona, New York, United States
United States, North Carolina
Research Site
Raleigh, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
United States, Ohio
Research Site
Cincinnati, Ohio, United States
United States, Oklahoma
Research Site
Tulsa, Oklahoma, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Research Site
Charleston, South Carolina, United States
United States, Tennessee
Research Facility
Nashville, Tennessee, United States
Research Facility
Memphis, Tennessee, United States
United States, Texas
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Ft Worth, Texas, United States
United States, Vermont
Research Site
Burlington, Vermont, United States
United States, Virginia
Research Site
Charlottesville, Virginia, United States
Research Site
Norfolk, Virginia, United States
Research Facility
Falls Church, Virginia, United States
United States, Washington
Research Site
Tacoma, Washington, United States
United States, Wisconsin
Research Site
Milwaukee, Wisconsin, United States

Sponsors and Collaborators

Procter and Gamble

Investigators

Study Director:

Jeffery Kralstein, MD

Procter and Gamble

More Information

No publications provided

Responsible Party:	Procter and Gamble ( Piotr Krzeski, MD )
Study ID Numbers:	2000083
Study First Received:	December 19, 2007
Last Updated:	February 11, 2008
ClinicalTrials.gov Identifier:	NCT00577473 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Gastrointestinal Diseases
Mesalamine
Ulcer
Physiological Effects of Drugs
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Pharmacologic Actions
Digestive System Diseases

Pathologic Processes
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Gastroenteritis
Central Nervous System Agents
Colitis

ClinicalTrials.gov processed this record on November 25, 2009