Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis

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

Sponsors

Lead Sponsor: Warner Chilcott

Source Warner Chilcott
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.

Overall Status Completed
Start Date September 2000
Completion Date September 2003
Primary Completion Date September 2003
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population 6 Weeks
Secondary Outcome
Measure Time Frame
Change From Baseline in Ulcerative Colitis Disease Activity Index (UCDAI) at Week 6, ITT Population 6 weeks
Percentage of Participants Whose Rectal Bleeding & Sigmoidoscopy Score Both Improved From Baseline to Week 6, ITT Population 6 Weeks
Percentage of Patients Whose Sigmoidoscopy Score Improved From Baseline to Week 6, ITT Population 6 Weeks
Percentage of Patients With an Improvement in Stool Frequency, ITT Population, Week 6 6 Weeks
Percentage of Patients With Improvement in Rectal Bleeding, ITT Population, Week 6 6 Weeks
Percentage of Patients With Improvement in Patient's Functional Assessment (PFA), ITT Population, Week 6 6 Weeks
Percentage of Patients With Improvement in Physician Global Assessment (PGA)Score, ITT Population, Week 6 6 Weeks
Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 3, All Randomized Patients 3 Weeks
Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 6, All Randomized Patients 6 Weeks
Percentage of Patients With Moderate, Left-Sided Disease at Baseline Classified as Treatment Success at Week 6, All Randomized Patients 6 Weeks
Percentage of Treatment Success Patients at Week 3, ITT Population 3 Weeks
Enrollment 386
Condition
Intervention

Intervention Type: Drug

Intervention Name: Asacol 800 mg (mesalamine)

Description: tablets, 4.8 g/day for 6 weeks, 2 - 800 mg Asacol tablets and 2 placebo tablets 3 times daily

Arm Group Label: Asacol 4.8 g/day

Intervention Type: Drug

Intervention Name: Asacol 400 mg (mesalamine)

Description: tablets, 2.4 g/day for 6 weeks, 2 - 400 mg Asacol tablets and 2 placebo tablets 3 times daily

Arm Group Label: Asacol 2.4 g/day

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Piotr Krzeski, MD Study Director Procter and Gamble
Location
Facility:
Mayo Clinic Scottsdale | Scottsdale, Arizona, 85259, United States
AGMG Clinical Research | Anaheim, California, 92801, United States
Research Site | Los Angeles, California, 90067, United States
Community Clinical Trials | Orange, California, 38305, United States
AGMG Clinical Research | Orange, California, 92869, United States
Research Site | Sacramento, California, 95825, United States
Sharp Rees-Stealy Medical Group | San Diego, California, 92123, United States
Research Site | Arvada, Colorado, 80002, United States
Research Site | Englewood, Colorado, 80110, United States
Center for Medical Research, LLC | Manchester, Connecticut, 06040, United States
Center for GI Disorders | Hollywood, Florida, 33021, United States
Research Site | Maitland, Florida, 32789, United States
Advanced Gastroenterology Associates | Palm Harbor, Florida, 34684, United States
Research Site | Zephyrhills, Florida, 33540, United States
Southeast Research Associates | Marietta, Georgia, 30067, United States
University of Chicago Medical Center | Chicago, Illinois, 60637, United States
GI Research | Metairie, Louisiana, 70001, United States
Louisiana Research Center | Shreveport, Louisiana, 71103, United States
Digestive Disorders Associates | Annapolis, Maryland, 21401, United States
Research Site | Baltimore, Maryland, 21215, United States
Digestive Disease Associates | Baltimore, Maryland, 21229, United States
Metropolitan Gastroenterology Group | Chevy Chase, Maryland, 20815, United States
Brigham & Women's Hospital | Boston, Massachusetts, 02115, United States
Henry Ford Hospital | Detroit, Michigan, 48202, United States
Mayo Clinic | Rochester, Minnesota, 55905, United States
PharmaTrials, Inc. | Hillsborough, New Jersey, 08844, United States
Research Site | Forest Hills, New York, 11375, United States
Long Island Clinical Research Associates | Great Neck, New York, 11021, United States
Research Site | New York, New York, 10128, United States
Carolinas Digestive Health Associates | Charlotte, North Carolina, 28262, United States
Research Site | Raleigh, North Carolina, 27612, United States
Research Site | Statesville, North Carolina, 28677, United States
Consultants for Clinical Research | Cincinnati, Ohio, 45219, United States
Research Site | Cincinnati, Ohio, 45267, United States
Research Site | Columbus, Ohio, 43215, United States
GI & Liver Consultants | Dayton, Ohio, 45440, United States
Research Site | Oklahoma City, Oklahoma, 73190, United States
Research Site | Tulsa, Oklahoma, 74135, United States
West Hills Gastroenterology Group | Portland, Oregon, 97225, United States
Research Site | Altoona, Pennsylvania, 16602, United States
Research Site | Hanover, Pennsylvania, 17331, United States
Regional Research Institute | Jackson, Tennessee, 38305, United States
Research Site | Austin, Texas, 78705, United States
Research Site | Dallas, Texas, 75246, United States
Research Site | Houston, Texas, 77030, United States
Houston Medical Research Associates | Houston, Texas, 77090, United States
Research Site | Temple, Texas, 76508, United States
Research Site | Ogden, Utah, 84405, United States
Charlottesville Medical Research | Charlottesville, Virginia, 22902, United States
Research Site | Fairfax, Virginia, 22031, United States
Research Site | Fredricksburg, Virginia, 22401, United States
Richmond GI Research | Richmond, Virginia, 23226, United States
Research Site | Spokane, Washington, 99207, United States
Wisconsin Center for Advanced Research | Milwaukee, Wisconsin, 53207, United States
Research Site | Richmond, British Columbia, V7C 5L9, Canada
Research Site | Toronto, Ontario, M5B 1W8, Canada
University of Puerto Rico, School of Medicine | San Juan, 00935, Puerto Rico
Location Countries

Canada

Puerto Rico

United States

Verification Date

June 2015

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Asacol 2.4 g/day

Type: Active Comparator

Description: Asacol (2.4 g/day)

Label: Asacol 4.8 g/day

Type: Experimental

Description: Asacol (4.8 g/day)

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov