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Double-blind, double-dummy, randomised, placebo-controlled, multi-centre phase III study on the efficacy and tolerability of a 8-week treatment with 9 mg budesonide vs. 3 g mesalazine vs. placebo in patients with lymphocytic colitis

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Trial Profile

Double-blind, double-dummy, randomised, placebo-controlled, multi-centre phase III study on the efficacy and tolerability of a 8-week treatment with 9 mg budesonide vs. 3 g mesalazine vs. placebo in patients with lymphocytic colitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2018

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At a glance

  • Drugs Budesonide (Primary) ; Mesalazine (Primary)
  • Indications Microscopic colitis
  • Focus Registrational; Therapeutic Use
  • Sponsors Dr Falk Pharma

Most Recent Events

  • 06 Sep 2018 Primary endpoint (Clinical remission at week 8 / EOT comparison between Salofalk granules and placebo.) has not been met, according to results published in the Gastroenterology.
  • 06 Sep 2018 Primary endpoint (Clinical remission at week 8 / EOT comparison between Budenofalk granules placebo.) has been met, according to results published in the Gastroenterology.
  • 06 Sep 2018 Results published in the Gastroenterology

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