Trials / Completed
CompletedNCT01100151
ALK37-003: A Study of RDC-1036 (ALKS 37) in Adults With Opioid-induced Constipation (OIC)
A Phase 2 Study of the Effects of RDC-1036 Administered to Subjects With Opioid-induced Constipation During Treatment With Opioids for Chronic Pain
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Alkermes, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the safety and tolerability of RDC-1036 (ALKS 37) in adults with opioid-induced constipation (OIC) following repeat dose administration
Detailed description
Approximately 60 subjects will be enrolled in 1 of 2 cohorts. Following a review of Cohort 1 safety and tolerability data, subjects will then be enrolled into Cohort 2, to explore additional doses. Dose escalation will occur in both cohorts. There will be 18 visits over a 6-week period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RDC-1036 (ALKS 37) | Capsules for oral administration |
| DRUG | Placebo | Capsules for oral administration |
Timeline
- Start date
- 2010-04-01
- Primary completion
- 2010-12-01
- Completion
- 2010-12-01
- First posted
- 2010-04-08
- Last updated
- 2011-08-23
Locations
11 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01100151. Inclusion in this directory is not an endorsement.