Double-Blind, Randomised, Placebo-Controlled Multicentre Phase III Clinical Study Followed by Open-Label Phase on the Efficacy and Tolerability of Budesonide 3 mg Effervescent Tablet in Patients With Resistant Oral Chronic GvHD.

Trial Profile

Double-Blind, Randomised, Placebo-Controlled Multicentre Phase III Clinical Study Followed by Open-Label Phase on the Efficacy and Tolerability of Budesonide 3 mg Effervescent Tablet in Patients With Resistant Oral Chronic GvHD.

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Jul 2016

At a glance

  • Drugs Budesonide (Primary)
  • Indications Graft-versus-host disease
  • Focus Registrational; Therapeutic Use
  • Acronyms BUM-5
  • Sponsors Dr Falk Pharma
  • Most Recent Events

    • 20 Jan 2016 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
    • 09 Feb 2015 Planned End Date changed from 1 Dec 2014 to 1 Dec 2015 as reported by ClinicalTrials.gov.
    • 09 Feb 2015 Planned primary completion date changed from 1 Dec 2014 to 1 Dec 2015 as reported by ClinicalTrials.gov.
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