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

Sponsored by:	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

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Mesalamine

U.S. FDA Resources

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

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

Show 44 Study Locations

Sponsors and Collaborators

Procter and Gamble

Investigators

Study Director:

Jeffery Kralstein, MD

Procter and Gamble

More Information

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
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Digestive System Diseases
Mesalamine
Gastrointestinal Diseases
Ulcer
Colonic Diseases

Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Colitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Pathologic Processes
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs

Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009