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

Warner Chilcott30 sites in 3 countries386 target enrollmentSeptember 2000

ConditionsUlcerative Colitis

InterventionsAsacol 400 mg (mesalamine)Asacol 800 mg (mesalamine)

DrugsAsacol 800 mg (mesalamine)Asacol 400 mg (mesalamine)

Overview

Phase: Phase 3
Intervention: Asacol 400 mg (mesalamine)
Conditions: Ulcerative Colitis
Sponsor: Warner Chilcott
Enrollment: 386
Locations: 30
Primary Endpoint: Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2000

End Date

September 2003

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Warner Chilcott

Responsible Party

Sponsor

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);

Arms & Interventions

Asacol 2.4 g/day

Asacol (2.4 g/day)

Intervention: Asacol 400 mg (mesalamine)

Asacol 4.8 g/day

Asacol (4.8 g/day)

Intervention: Asacol 800 mg (mesalamine)

Outcomes

Primary Outcomes

Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population

Time Frame: 6 Weeks

Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment \[stool frequency, rectal bleeding, PFA, sigmoidoscopy\] and no worsening in any other clinical assessments)

Secondary Outcomes

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)