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”

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.

Intervention(s) in this Clinical Trial

• Drug: Asacol 800 mg (mesalamine)
  • tablets, 4.8 g/day for 6 weeks, 2 - 800 mg Asacol tablets and 2 placebo tablets 3 times daily
• Drug: Asacol 400 mg (mesalamine)
  • tablets, 2.4 g/day for 6 weeks, 2 - 400 mg Asacol tablets and 2 placebo tablets 3 times daily

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Asacol 2.4 g/day
  • Asacol (2.4 g/day)
• Experimental: Asacol 4.8 g/day
  • Asacol (4.8 g/day)

Primary Measures

• Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population
  • Time Frame: 6 Weeks
    Safety Issue?: No

Secondary Measures

• Change From Baseline in Ulcerative Colitis Disease Activity Index (UCDAI) at Week 6, ITT Population
  • Time Frame: 6 weeks
    Safety Issue?: No
• Percentage of Participants Whose Rectal Bleeding & Sigmoidoscopy Score Both Improved From Baseline to Week 6, ITT Population
  • Time Frame: 6 Weeks
    Safety Issue?: No
• Percentage of Patients Whose Sigmoidoscopy Score Improved From Baseline to Week 6, ITT Population
  • Time Frame: 6 Weeks
    Safety Issue?: No
• Percentage of Patients With an Improvement in Stool Frequency, ITT Population, Week 6
  • Time Frame: 6 Weeks
    Safety Issue?: No
• Percentage of Patients With Improvement in Rectal Bleeding, ITT Population, Week 6
  • Time Frame: 6 Weeks
    Safety Issue?: No
• Percentage of Patients With Improvement in Patient's Functional Assessment (PFA), ITT Population, Week 6
  • Time Frame: 6 Weeks
    Safety Issue?: No
• Percentage of Patients With Improvement in Physician Global Assessment (PGA)Score, ITT Population, Week 6
  • Time Frame: 6 Weeks
    Safety Issue?: No
• Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 3, All Randomized Patients
  • Time Frame: 3 Weeks
    Safety Issue?: No
• Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 6, All Randomized Patients
  • Time Frame: 6 Weeks
    Safety Issue?: No
• Percentage of Patients With Moderate, Left-Sided Disease at Baseline Classified as Treatment Success at Week 6, All Randomized Patients
  • Time Frame: 6 Weeks
    Safety Issue?: No
• Percentage of Treatment Success Patients at Week 3, ITT Population
  • Time Frame: 3 Weeks
    Safety Issue?: No

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Warner Chilcott Industry

Overall Clinical Trial Officials and Contacts

Piotr Krzeski, MD Study Director Procter and Gamble  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00073021

Study ID Number: 2000082

ClinicalTrials.gov Identifier: NCT00073021

Health Authority: United States: Food and Drug Administration