Trials / Terminated
TerminatedNCT01925950
Study of orBec® as Monotherapy in the Treatment of Patients With Upper GI Symptoms Caused by Chronic Graft Versus Host Disease (GVHD)
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of orBec® (Oral Beclomethasone 17,21-Dipropionate) Administered as Monotherapy in the Treatment of Upper Gastrointestinal (GI) Symptoms Caused by GVHD in Patients With Chronic GI GVHD
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 2 (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 may control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | orBec | |
| DRUG | Placebo |
Timeline
- Start date
- 2013-12-01
- Primary completion
- 2015-05-01
- Completion
- 2015-05-01
- First posted
- 2013-08-20
- Last updated
- 2018-11-01
- Results posted
- 2018-10-04
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01925950. Inclusion in this directory is not an endorsement.