A Randomized, Double-blind, Placebo-controlled, Multi-centre, Superiority Study Investigating the Efficacy and Safety of PENTASA Enema Compared With Placebo Enema for 4-Week Treatment in Chinese Patients With Left-sided Active Ulcerative Colitis (UC) Followed by a Maximal 28-Week Open-Label Extension Phase of PENTASA Enema and/or PENTASA Tablets

Trial Profile

A Randomized, Double-blind, Placebo-controlled, Multi-centre, Superiority Study Investigating the Efficacy and Safety of PENTASA Enema Compared With Placebo Enema for 4-Week Treatment in Chinese Patients With Left-sided Active Ulcerative Colitis (UC) Followed by a Maximal 28-Week Open-Label Extension Phase of PENTASA Enema and/or PENTASA Tablets

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 02 Feb 2017

At a glance

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

    • 17 Jan 2017 Planned End Date changed from 1 Apr 2017 to 1 Jul 2017.
    • 17 Jan 2017 Planned primary completion date changed from 1 Dec 2016 to 1 Jan 2017.
    • 17 Jan 2017 Status changed from recruiting to active, no longer recruiting.
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