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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 is a Phase 2 study of OIC that has completed, run by Alkermes. The registered enrollment target is 91 participants. The trial reports 13 study locations across 10 states.

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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

Sponsor

Alkermes

66 total trials

What the Registry Record Tells You About NCT01418092

The ClinicalTrials.gov registry entry for NCT01418092 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 91 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alkermes, which has 66 total studies on file at ClinicalTrials.gov.

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 reports 13 study locations spanning 10 distinct geographic areas - top geographies include 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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.