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NCT01418092 · ClinicalTrials.gov registry record · Phase 2
ALK37-007: Evaluation of Safety and Efficacy of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)
A Phase 2 study of OIC, sponsored by Alkermes.
- Completed
- Registry status
- Phase 2
- Development phase
- 91
- Enrollment target
- 13
- Study locations
NCT01418092: Completed Phase 2 study of OIC, sponsored by Alkermes.
NCT01418092 is a Phase 2 study of OIC that has completed, run by Alkermes. The registered enrollment target is 91 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). The trial reports 13 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01418092, a Phase 2 study of OIC, has completed, sponsored by Alkermes.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 91 participants
- Enrollment target
- 13
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and efficacy of ALKS 37 when administered daily to adults with OIC.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ALKS 37
Study Locations (13)
California
- Alkermes Investigational Site - Anaheim
- Alkermes Investigational Site - Orange
Florida
- Alkermes Investigational Site - Daytona Beach
- Alkermes Investigational Site - Plantation
Texas
- Alkermes Investigational Site - Austin
- Alkermes Investigational Site - Houston
Georgia
- Alkermes Investigational Site - Marietta
Indiana
- Alkermes Investigational Site - Indianapolis
Nevada
- Alkermes Investigational Site - Las Vegas
New Jersey
- Alkermes Investigational Site - Willingboro
North Carolina
- Alkermes Investigational Site - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-06 |
| Phase | Phase 2 |
What the finished NCT01418092 record still lists
NCT01418092 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 1 condition, with OIC appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01418092 lists 13 locations in 10 states (California, Florida, Texas).
Frequently Asked Questions
What is clinical trial NCT01418092 about?
NCT01418092 is a clinical study titled "ALK37-007: Evaluation of Safety and Efficacy of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)". The purpose of this study is to evaluate the safety and efficacy of ALKS 37 when administered daily to adults with OIC.
What is the current status of trial NCT01418092?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2011-09. Estimated completion is 2012-06.
What conditions does trial NCT01418092 study?
This clinical trial studies the following conditions: OIC.
What interventions are being tested in trial NCT01418092?
The interventions under investigation include: Placebo (DRUG), ALKS 37 (DRUG).
Who is sponsoring clinical trial NCT01418092?
This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01418092 being conducted?
This trial has 13 study locations across California, Florida, Georgia, Indiana, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01418092's enrollment target sits among peer trials
91 771st of 2000 higher than 1,229 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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