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NCT00256932 · ClinicalTrials.gov registry record · Phase 3

Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

A Phase 3 study of Constipation and Bowel Dysfunction, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

Completed
Registry status
Phase 3
Development phase
518
Enrollment target
20
Study locations

NCT00256932 is a Phase 3 study of Constipation and Bowel Dysfunction that has completed, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 518 participants, above the 196-participant average among 54 other Constipation trials with a reported enrollment target (164% higher). The trial reports 20 study locations across 4 states.

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The verdict

NCT00256932, a Phase 3 study of Constipation and Bowel Dysfunction, has completed, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

COMPLETED
Registry status
Phase 3
Development phase
518 participants
Enrollment target
20
Study locations

Study Summary

Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.

Conditions Studied

Constipation Bowel Dysfunction

Interventions

  • DRUG Placebo
  • DRUG alvimopan

Study Locations (20)

California

  • GSK Investigational Site - Anaheim
  • GSK Investigational Site - Anaheim
  • GSK Investigational Site - Beuna Park
  • GSK Investigational Site - Burbank
  • GSK Investigational Site - Duarte
  • GSK Investigational Site - Fountain Valley
  • GSK Investigational Site - Huntington Beach

Arizona

  • GSK Investigational Site - Glendale
  • GSK Investigational Site - Phoenix
  • GSK Investigational Site - Phoenix
  • GSK Investigational Site - Sun City
  • GSK Investigational Site - Tucson
  • GSK Investigational Site - Tucson

Alabama

  • GSK Investigational Site - Birmingham
  • GSK Investigational Site - Birmingham
  • GSK Investigational Site - Calera
  • GSK Investigational Site - Muscle Shoals
  • GSK Investigational Site - Tallassee

Arkansas

  • GSK Investigational Site - Hot Springs
  • GSK Investigational Site - Little Rock

Trial Details

FieldValue
Enrollment Target 518 participants
Start Date 2005-08
Est. Completion 2006-05
Phase Phase 3

Sponsor

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

42 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00256932

The ClinicalTrials.gov registry entry for NCT00256932 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 518 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 196-participant average among 54 other Constipation trials with a reported enrollment target (164% higher). The listed sponsor is Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 42 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Constipation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00256932 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Arizona, Alabama.

Frequently Asked Questions

What is clinical trial NCT00256932 about?

NCT00256932 is a clinical study titled "Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain". Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy ...

What is the current status of trial NCT00256932?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 518 participants. The study started on 2005-08. Estimated completion is 2006-05.

What conditions does trial NCT00256932 study?

This clinical trial studies the following conditions: Constipation, Bowel Dysfunction.

What interventions are being tested in trial NCT00256932?

The interventions under investigation include: Placebo (DRUG), alvimopan (DRUG).

Who is sponsoring clinical trial NCT00256932?

This trial is sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 42 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00256932 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.