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NCT00402038 · ClinicalTrials.gov registry record · Phase 3

Study of Methylnaltrexone (MNTX) for the Relief of Constipation

A Phase 3 study, sponsored by Bausch Health Americas.

Completed
Registry status
Phase 3
Development phase
134
Enrollment target

NCT00402038: Completed Phase 3 study, sponsored by Bausch Health Americas.

NCT00402038 is a Phase 3 study that has completed, run by Bausch Health Americas. The registered enrollment target is 134 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00402038, a Phase 3 study, has completed, sponsored by Bausch Health Americas.

COMPLETED
Registry status
Phase 3
Development phase
134 participants
Enrollment target

Study Summary

To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in patients with advanced medical illness.

Primary Outcome

To determine the efficacy of a single dose of SC MNTX compared with placebo in inducing laxation within 4 hours. To determine the efficacy of SC MNTX every other day over a 1-week treatment period in relieving OIC in patients with AMI.

Interventions

  • DRUG SC Placebo
  • DRUG SC Methylnaltrexone

Trial Details

FieldValue
Enrollment Target 134 participants
Start Date 2004-02
Est. Completion 2005-10
Phase Phase 3
Bausch Health Americas

168 total trials

What the finished NCT00402038 record still lists

NCT00402038 is an interventional study that assigns participants to a tested intervention. The registered 134 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 (83% lower).

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

NCT00402038 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00402038 about?

NCT00402038 is a clinical study titled "Study of Methylnaltrexone (MNTX) for the Relief of Constipation". To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in patients with advanced medical illness.

What is the current status of trial NCT00402038?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 134 participants. The study started on 2004-02. Estimated completion is 2005-10.

What interventions are being tested in trial NCT00402038?

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

Who is sponsoring clinical trial NCT00402038?

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 NCT00402038's enrollment target sits among peer trials

134 1585th of 2000 higher than 413 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 NCT00402038, the US trial registry maintained by the National Library of Medicine. NCT00402038 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.