A Multicentre, Randomised, Double-blind, Non-inferiority Trial Comparing the Efficacy and Safety of a New Modified Oral Extended Release Pentasa (Mesalamine) 500 mg Tablet to the Currently Marketed Pentasa (Mesalamine) 500 mg Tablet in Subjects With Active Mild to Moderate Ulcerative Colitis Treated With 4 g/Day for 8 Weeks and in Maintenance of Remission of Ulcerative Colitis in Subjects Treated With 2 g/Day for 24 Weeks

Trial Profile

A Multicentre, Randomised, Double-blind, Non-inferiority Trial Comparing the Efficacy and Safety of a New Modified Oral Extended Release Pentasa (Mesalamine) 500 mg Tablet to the Currently Marketed Pentasa (Mesalamine) 500 mg Tablet in Subjects With Active Mild to Moderate Ulcerative Colitis Treated With 4 g/Day for 8 Weeks and in Maintenance of Remission of Ulcerative Colitis in Subjects Treated With 2 g/Day for 24 Weeks

Completed
Phase of Trial: Phase III

Latest Information Update: 25 Apr 2016

At a glance

  • Drugs Mesalazine (Primary)
  • Indications Ulcerative colitis
  • Focus Therapeutic Use
  • Acronyms CAMMP
  • Sponsors Ferring Pharmaceuticals
  • Most Recent Events

    • 29 Jun 2011 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 13 Apr 2011 Planned number of patients changed from 394 to 343 as reported by ClinicalTrials.gov.
    • 13 Apr 2011 Planned End Date changed from 1 Apr 2011 to 1 Jun 2011 as reported by ClinicalTrials.gov.
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