Trials / Completed
CompletedNCT02267525
The Diabetic and Idiopathic Gastroparesis Efficacy, Safety, and Tolerability (DIGEST) Study
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy, Safety, and Tolerability of Velusetrag for the Treatment of Diabetic or Idiopathic Gastroparesis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 233 (actual)
- Sponsor
- Theravance Biopharma · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Study 0099 explores the efficacy and safety of multiple doses of velusetrag in the treatment of symptoms in subjects with diabetic or idiopathic gastroparesis. Three dose levels of velusetrag will be evaluated and compared to placebo for approximately 12 weeks of therapy. In addition, the study will be used to evaluate the psychometric properties of the Gastroparesis Rating Scale (GRS), a daily patient-reported outcome (PRO) measure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Velusetrag | |
| DRUG | Placebo |
Timeline
- Start date
- 2014-12-01
- Primary completion
- 2017-06-01
- Completion
- 2017-06-01
- First posted
- 2014-10-17
- Last updated
- 2018-04-17
Source: ClinicalTrials.gov record NCT02267525. Inclusion in this directory is not an endorsement.