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

Dr. Falk Pharma GmbH2 sites in 2 countries186 target enrollmentMarch 2009

ConditionsOral Chronic Graft vs Host Disease

InterventionsBudesonide Placebo

DrugsBudesonide Placebo

Overview

Phase: Phase 3
Intervention: Budesonide
Conditions: Oral Chronic Graft vs Host Disease
Sponsor: Dr. Falk Pharma GmbH
Enrollment: 186
Locations: 2
Primary Endpoint: Rate of patients with objective response
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to compare the efficacy and tolerability of budesonide 3 mg effervescent tablet (9 mg/day) compared to placebo for the treatment of patients with resistant oral cGvHD.

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

October 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Dr. Falk Pharma GmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Karnofsky \>= 70
•Oral chronic GvHD after allogeneic haematopoietic stem cell transplantation
•Oral cGvHD of erosive and/or ulcerative type
•NIH scale \>= 3
•Resistant oral cGvHD with no oral response to conventional primary treatment

Exclusion Criteria

•Uncertain diagnosis of resistant oral cGvHD
•Symptomatic oral cGvHD of hyperkeratotic type solely
•Current active oral bacterial, viral, or fungal infection
•Unwilling to forego concurrent treatment for mucosal lesions and/or related oral pain
•Requiring addition of new systemic therapy including steroids, or radiation therapy
•Local intestinal infection
•Abnormal hepatic function or liver cirrhosis
•If careful medical monitoring is not ensured: tuberculosis, cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, infection
•Second line treatment of oral cGvHD with topical steroids

Arms & Interventions

A

Intervention: Budesonide

B

Intervention: Placebo

Outcomes

Primary Outcomes

Rate of patients with objective response

Time Frame: 12 weeks

Secondary Outcomes

Rate of complete/partial response, stable disease, progressive disease(12 weeks)
Time to initial objective response(x weeks)
Rate of subjective improvement(12 weeks)