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NCT01382797 · ClinicalTrials.gov registry record · Phase 2
ALK37-005: A Study of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)
A Phase 2 study, sponsored by Alkermes.
- Completed
- Registry status
- Phase 2
- Development phase
- 157
- Enrollment target
NCT01382797: Completed Phase 2 study, sponsored by Alkermes.
NCT01382797 is a Phase 2 study that has completed, run by Alkermes. The registered enrollment target is 157 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (18% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01382797, a Phase 2 study, has completed, sponsored by Alkermes.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 157 participants
- Enrollment target
Study 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).
Primary Outcome
Overall response will be defined using an algorithm that takes into consideration number of complete spontaneous bowel movements, improvement from baseline, and durability of response.
Interventions
- DRUG Placebo
- DRUG ALKS 37
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 157 participants |
| Start Date | 2011-08 |
| Est. Completion | 2012-04 |
| Phase | Phase 2 |
What the finished NCT01382797 record still lists
NCT01382797 is an interventional study that assigns participants to a tested intervention. The registered 157 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (18% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01382797 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01382797 about?
NCT01382797 is a clinical study titled "ALK37-005: A Study of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)". 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).
What is the current status of trial NCT01382797?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 157 participants. The study started on 2011-08. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01382797?
The interventions under investigation include: Placebo (DRUG), ALKS 37 (DRUG).
Who is sponsoring clinical trial NCT01382797?
This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01382797's enrollment target sits among peer trials
157 443rd of 2000 higher than 1,556 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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