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Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine

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Trial Profile

Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Sep 2023

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At a glance

  • Drugs Budesonide (Primary)
  • Indications Ulcerative colitis
  • Focus Therapeutic Use
  • Acronyms TOPICAL-2
  • Sponsors Dr Falk Pharma

Most Recent Events

  • 30 Nov 2022 This trial has been competed in Poland (Global end date 03 Oct 2022), according to European Clinical Trials Database record.
  • 13 Oct 2022 This trial has been competed in Germany(Global end date 03 Oct 2022), according to European Clinical Trials Database record.
  • 26 Aug 2022 This trial has been discontinued in Slovakia, according to European Clinical Trials Database record.

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