Trials / Completed
CompletedNCT01418092
ALK37-007: Evaluation of Safety and Efficacy of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)
A Phase 2b Randomized, Double-blind, Placebo-controlled, 12-week Study to Evaluate the Safety and Efficacy of ALKS 37 in Subjects With Opioid-induced Constipation
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 91 (actual)
- Sponsor
- Alkermes, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and efficacy of ALKS 37 when administered daily to adults with OIC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALKS 37 | Capsules for oral administration |
| DRUG | Placebo | Capsules for oral administration |
Timeline
- Start date
- 2011-09-01
- Primary completion
- 2012-06-01
- Completion
- 2012-06-01
- First posted
- 2011-08-16
- Last updated
- 2012-08-07
Locations
13 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01418092. Inclusion in this directory is not an endorsement.