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NCT00529087 · ClinicalTrials.gov registry record · Phase 3

Study Evaluating Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation (OIC) in Subjects With Chronic Non-Malignant Pain

A Phase 3 study, sponsored by Bausch Health Americas.

Completed
Registry status
Phase 3
Development phase
460
Enrollment target

NCT00529087: Completed Phase 3 study, sponsored by Bausch Health Americas.

NCT00529087 is a Phase 3 study that has completed, run by Bausch Health Americas. The registered enrollment target is 460 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00529087, a Phase 3 study, has completed, sponsored by Bausch Health Americas.

COMPLETED
Registry status
Phase 3
Development phase
460 participants
Enrollment target

Study Summary

The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of subcutaneous MOA-728 versus placebo in subjects with chronic non-malignant pain who have Opioid-Induced Constipation (OIC).

Primary Outcome

A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS).

Interventions

  • OTHER placebo
  • DRUG N-methylnaltrexone bromide (MOA-728)

Trial Details

FieldValue
Enrollment Target 460 participants
Start Date 2007-08
Est. Completion 2008-12
Phase Phase 3
Bausch Health Americas

168 total trials

What the finished NCT00529087 record still lists

NCT00529087 is an interventional study that assigns participants to a tested intervention. The registered 460 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 (40% lower).

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT00529087 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00529087 about?

NCT00529087 is a clinical study titled "Study Evaluating Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation (OIC) in Subjects With Chronic Non-Malignant Pain". The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of subcutaneous MOA-728 versus placebo in subjects with chronic non-malignant pain who have Opioid-Induced Constipation (OIC).

What is the current status of trial NCT00529087?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 460 participants. The study started on 2007-08. Estimated completion is 2008-12.

What interventions are being tested in trial NCT00529087?

The interventions under investigation include: placebo (OTHER), N-methylnaltrexone bromide (MOA-728) (DRUG).

Who is sponsoring clinical trial NCT00529087?

This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00529087's enrollment target sits among peer trials

460 823rd of 2000 higher than 1,174 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 NCT00529087, the US trial registry maintained by the National Library of Medicine. NCT00529087 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.