Trials / Completed
CompletedNCT01382797
ALK37-005: A Study of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)
A Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose Study to Evaluate the Safety, Tolerability, and Efficacy of ALKS 37 in Subjects With Opioid-induced Constipation
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 157 (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, tolerability and efficacy of ALKS 37 when administered daily for 4 weeks to adults with Opioid-induced Constipation (OIC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALKS 37 | Capsules for oral administration |
| DRUG | Placebo | Capsules for oral administration |
Timeline
- Start date
- 2011-08-01
- Primary completion
- 2012-04-01
- Completion
- 2012-04-01
- First posted
- 2011-06-27
- Last updated
- 2012-06-13
Locations
20 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01382797. Inclusion in this directory is not an endorsement.