Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)

Verified by: Warner Chilcott, September 2011
First Received: December 19, 2007 | Last Updated: September 14, 2011 | Phase: Phase 3 | Start Date: February 2001
Overall Status: Completed | Estimated Enrollment: 301
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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...

Brief Summary

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”

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

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: February 2003

Detailed Clinical Trial 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.

Intervention(s) in this Clinical Trial

  • Drug: mesalamine
    • mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
  • Drug: mesalamine
    • mesalamine 4.8 g/day (800 mg tablet) for 6 weeks

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
    • mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
  • Experimental: 2
    • mesalamine 4.8 g/day (800 mg tablet) for 6 weeks

Outcome Measures for this Clinical Trial

Primary Measures

  • Percentage of Patients Classified as Treatment Success at Week 6, ITT Population
    • Time Frame: 6 weeks
      Safety Issue?: Yes

Secondary Measures

  • Percentage of Patients Classified as Treatment Success at Week 3, ITT Population
    • Time Frame: 3 weeks
      Safety Issue?: Yes
  • Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 3, All Randomized Patients
    • Time Frame: Week 3
      Safety Issue?: No
  • Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 6, All Randomized Patients
    • Time Frame: Week 6
      Safety Issue?: No
  • Stool Frequency Improvement at Week 3, All Randomized Patients (Percentage)
    • Time Frame: Week 3
      Safety Issue?: No
  • Stool Frequency Improvement at Week 6, All Randomized Patients (Percentage)
    • Time Frame: Week 6
      Safety Issue?: No
  • Rectal Bleeding Improvement at Week 3, All Randomized Patients (Percentage)
    • Time Frame: Week 3
      Safety Issue?: No
  • Rectal Bleeding Improvement at Week 6, All Randomized Patients (Percentage)
    • Time Frame: Week 6
      Safety Issue?: No
  • Improvement in Patient's Functional Assessment (PFA) at Week 3, All Randomized Patients (Percentage)
    • Time Frame: Week 3
      Safety Issue?: No
  • Improvement in Patient's Functional Assessment (PFA) at Week 6, All Randomized Patients (Percentage)
    • Time Frame: Week 6
      Safety Issue?: No
  • Improvement in Patient's Sigmoidoscopy Assessment Score at Week 3, All Randomized Patients (Percentage)
    • Time Frame: Week 3
      Safety Issue?: No
  • Improvement in Patient's Sigmoidoscopy Assessment Score at Week 6, All Randomized Patients (Percentage)
    • Time Frame: Week 6
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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 resection

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Warner Chilcott Industry

Overall Clinical Trial Officials and Contacts

Jeffery Kralstein, MD Study Director Procter and Gamble  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00577473

Study ID Number: 2000083

ClinicalTrials.gov Identifier: NCT00577473

Health Authority: United States: Food and Drug Administration

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