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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.

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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

FieldValue
Enrollment Target 91 participants
Start Date 2011-09
Est. Completion 2012-06
Phase Phase 2
Alkermes

66 total trials

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.

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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Source: ClinicalTrials.gov NCT01418092, the US trial registry maintained by the National Library of Medicine. NCT01418092 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.