Trials / Completed
CompletedNCT00887263
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 186 (actual)
- Sponsor
- Dr. Falk Pharma GmbH · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Budesonide | 3 mg TID |
| DRUG | Placebo | 0 mg TID |
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2015-10-01
- Completion
- 2015-10-01
- First posted
- 2009-04-23
- Last updated
- 2016-01-21
Locations
2 sites across 2 countries: Germany, Israel
Source: ClinicalTrials.gov record NCT00887263. Inclusion in this directory is not an endorsement.