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NCT00259922 · ClinicalTrials.gov registry record · Phase 3

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

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

Completed
Registry status
Phase 3
Development phase
485
Enrollment target

NCT00259922: Completed Phase 3 study, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

NCT00259922 is a Phase 3 study that has completed, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 485 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00259922, a Phase 3 study, has completed, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

COMPLETED
Registry status
Phase 3
Development phase
485 participants
Enrollment target

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 of 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.

Interventions

  • DRUG Placebo
  • DRUG Alvimopan
  • DRUG Alviompan

Trial Details

FieldValue
Enrollment Target 485 participants
Start Date 2005-08
Phase Phase 3

What the finished NCT00259922 record still lists

NCT00259922 is an interventional study that assigns participants to a tested intervention. The registered 485 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00259922 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00259922 about?

NCT00259922 is a clinical study titled "Alvimopan For The 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 of 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for effica...

What is the current status of trial NCT00259922?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 485 participants. The study started on 2005-08.

What interventions are being tested in trial NCT00259922?

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

Who is sponsoring clinical trial NCT00259922?

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.

How this trial's enrollment target compares

Where NCT00259922's enrollment target sits among peer trials

485 790th of 2000 higher than 1,210 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00259922, the US trial registry maintained by the National Library of Medicine. NCT00259922 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.