Efficacy and Safety Study of Budesonide to Treat Oral Chronic Graft vs Host Disease (cGvHD)

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00887263

Enrollment

186

Registered

2009-04-23

Start date

2009-03-31

Completion date

2015-10-31

Last updated

2016-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Chronic Graft vs Host Disease

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.

Interventions

DRUGBudesonide

3 mg TID

DRUGPlacebo

0 mg TID

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Rate of patients with objective response	12 weeks

Secondary

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

Countries

Germany, Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026