Clinical trial NCT00073021: Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis
Official title: A Double-Blind, Randomized, 6-Week, Parallel-Group Design Clinical Trial to Assess Safety and Efficacy of Asacol 4.8 g/Day (800 mg Tablet) Versus Asacol 2.4 g/Day (400 mg Tablet) for the Treatment of Moderately Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2003-11-17
Enrollment: 386
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a prospective clinical study to evaluate the safety and efficacy of two different doses of Asacol for the treatment of moderately active ulcerative colitis. In addition, a new tablet formulation will be evaluated at one of the two doses.


Eligibility criteria: Inclusion Criteria:

* male or female between 18 and 75 years of age;
* have a confirmed diagnosis of ulcerative colitis with the extent varying from proctitis to pancolitis;
* currently demonstrating moderately active disease

Exclusion Criteria:

Patients will be excluded from admission to the study if they have/are:

* a history of allergy or hypersensitivity to salicylates or aminosalicylates;
* a history of extensive small bowel resection (\>1/2 the length of the small intestine) causing short bowel syndrome;
* current renal or hepatic disease;
* participated in any drug or device clinical study within 30 days of entry;
* currently enrolled in any other clinical study;
* received any oral, intravenous, intramuscular, or rectally administered corticosteroids within 1 month prior to the Baseline Visit;
* received any other topical rectal therapy during the week prior to the Screening Visit;
* received immunomodulatory therapy including, but not limited to, 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate within 3 months prior to the Baseline Visit;
* received a dose of mesalamine-containing compound by any route from which more than 1.6 g/day of mesalamine was available within 1 week prior to the Screening Visit (NOTE: 4 g/day of sulfasalazine and 4.5 g/day of balsalazide are equivalent to 1.6 g/day of mesalamine);
* received antibiotics, other than topical antibiotics, within 1 week prior to the Screening Visit;
* received aspirin (except for cardioprotective reasons up to a maximum dose of 325 mg/day) or NSAIDs within 1 week prior to the Baseline Visit;
* if female, positive pregnancy test, or lactating.

Primary outcomes:
measure: Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population
timeFrame: 6 Weeks
Secondary outcomes:
measure: Change From Baseline in Ulcerative Colitis Disease Activity Index (UCDAI) at Week 6, ITT Population
timeFrame: 6 weeks
measure: Percentage of Participants Whose Rectal Bleeding & Sigmoidoscopy Score Both Improved From Baseline to Week 6, ITT Population
timeFrame: 6 Weeks
measure: Percentage of Patients Whose Sigmoidoscopy Score Improved From Baseline to Week 6, ITT Population
timeFrame: 6 Weeks
measure: Percentage of Patients With an Improvement in Stool Frequency, ITT Population, Week 6
timeFrame: 6 Weeks
measure: Percentage of Patients With Improvement in Rectal Bleeding, ITT Population, Week 6
timeFrame: 6 Weeks
measure: Percentage of Patients With Improvement in Patient's Functional Assessment (PFA), ITT Population, Week 6
timeFrame: 6 Weeks
measure: Percentage of Patients With Improvement in Physician Global Assessment (PGA)Score, ITT Population, Week 6
timeFrame: 6 Weeks
measure: Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 3, All Randomized Patients
timeFrame: 3 Weeks
measure: Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 6, All Randomized Patients
timeFrame: 6 Weeks
measure: Percentage of Patients With Moderate, Left-Sided Disease at Baseline Classified as Treatment Success at Week 6, All Randomized Patients
timeFrame: 6 Weeks
measure: Percentage of Treatment Success Patients at Week 3, ITT Population
timeFrame: 3 Weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Scottsdale
state: Arizona
city: Anaheim
country: United States
facility: AGMG Clinical Research
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Community Clinical Trials
state: California
city: Orange
country: United States
facility: AGMG Clinical Research
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy Medical Group
state: California
city: Arvada
country: United States
facility: Research Site
state: Colorado
city: Englewood
country: United States
facility: Research Site
state: Colorado
city: Manchester
country: United States
facility: Center for Medical Research, LLC
state: Connecticut
city: Hollywood
country: United States
facility: Center for GI Disorders
state: Florida
city: Maitland
country: United States
facility: Research Site
state: Florida
city: Palm Harbor
country: United States
facility: Advanced Gastroenterology Associates
state: Florida
city: Zephyrhills
country: United States
facility: Research Site
state: Florida
city: Marietta
country: United States
facility: Southeast Research Associates
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Metairie
country: United States
facility: GI Research
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center
state: Louisiana
city: Annapolis
country: United States
facility: Digestive Disorders Associates
state: Maryland
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Baltimore
country: United States
facility: Digestive Disease Associates
state: Maryland
city: Chevy Chase
country: United States
facility: Metropolitan Gastroenterology Group
state: Maryland
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Hillsborough
country: United States
facility: PharmaTrials, Inc.
state: New Jersey
city: Forest Hills
country: United States
facility: Research Site
state: New York
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Charlotte
country: United States
facility: Carolinas Digestive Health Associates
state: North Carolina
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Statesville
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: GI & Liver Consultants
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Tulsa
country: United States
facility: Research Site
state: Oklahoma
city: Portland
country: United States
facility: West Hills Gastroenterology Group
state: Oregon
city: Altoona
country: United States
facility: Research Site
state: Pennsylvania
city: Hanover
country: United States
facility: Research Site
state: Pennsylvania
city: Jackson
country: United States
facility: Regional Research Institute
state: Tennessee
city: Austin
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Houston Medical Research Associates
state: Texas
city: Temple
country: United States
facility: Research Site
state: Texas
city: Ogden
country: United States
facility: Research Site
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Fairfax
country: United States
facility: Research Site
state: Virginia
city: Fredricksburg
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Richmond GI Research
state: Virginia
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research
state: Wisconsin
city: Richmond
country: Canada
facility: Research Site
state: British Columbia
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico, School of Medicine
Study officials:
affiliation: Procter and Gamble
name: Piotr Krzeski, MD
role: STUDY_DIRECTOR
References:
citation: Orchard TR, van der Geest SA, Travis SP. Randomised clinical trial: early assessment after 2 weeks of high-dose mesalazine for moderately active ulcerative colitis - new light on a familiar question. Aliment Pharmacol Ther. 2011 May;33(9):1028-35. doi: 10.1111/j.1365-2036.2011.04620.x. Epub 2011 Mar 8.
citation: Lichtenstein GR, Ramsey D, Rubin DT. Randomised clinical trial: delayed-release oral mesalazine 4.8 g/day vs. 2.4 g/day in endoscopic mucosal healing--ASCEND I and II combined analysis. Aliment Pharmacol Ther. 2011 Mar;33(6):672-8. doi: 10.1111/j.1365-2036.2010.04575.x. Epub 2011 Jan 23.