Trials / Terminated
TerminatedNCT00926575
Study of orBec® With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of orBec® (Oral Beclomethasone 17,21-Dipropionate)in Conjunction With Ten Days of High-Dose Prednisone Therapy in the Treatment of Patients With Gastrointestinal GVHD
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 140 (actual)
- Sponsor
- Soligenix · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Use of an oral topically-active glucocorticoid with limited side effects will control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | oral beclomethasone 17,21-dipropionate | Two tablets QID for 50 days |
| DRUG | Placebo | Two tablets QID for 50 days |
Timeline
- Start date
- 2009-10-01
- Primary completion
- 2011-12-01
- Completion
- 2012-05-01
- First posted
- 2009-06-23
- Last updated
- 2013-12-06
- Results posted
- 2013-12-06
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00926575. Inclusion in this directory is not an endorsement.