Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine

Trial Profile

Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine

Discontinued
Phase of Trial: Phase III

Latest Information Update: 26 Sep 2017

At a glance

  • Drugs Phosphatidylcholine (Primary) ; Mesalazine
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms PROTECT-1
  • Sponsors Dr Falk Pharma
  • Most Recent Events

    • 23 Sep 2017 This trial has been completed in Hungary
    • 07 Feb 2017 Status changed from recruiting to discontinued due to IDMC recommendation.
    • 09 Dec 2016 This trial was discontinued in Poalnd (end date: 2016-10-13), according to European Clinical Trials Database.
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