A Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission With Endoscopic Response at 16 Weeks Followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects With Active Moderate Crohn's Disease

Trial Profile

A Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission With Endoscopic Response at 16 Weeks Followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects With Active Moderate Crohn's Disease

Recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Jul 2017

At a glance

  • Drugs Rifaximin (Primary)
  • Indications Crohn's disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Salix Pharmaceuticals; Valeant Pharmaceuticals International
  • Most Recent Events

    • 26 Apr 2017 Planned End Date changed from 1 Nov 2017 to 1 Jul 2020.
    • 26 Apr 2017 Planned primary completion date changed from 1 Nov 2017 to 1 May 2020.
    • 09 May 2013 Salix is discussing trial endpoints with the US FDA and anticipates trial initiation during the second half of 2013, according to a Salix media release.
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