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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

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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

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

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

    • Most Recent Events

    • 24 Oct 2018 Results presented at the 26th United European Gastroenterology Week
    • 17 Nov 2017 This trial has been completed in Germany.
    • 23 Sep 2017 This trial has been completed in Hungary
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