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NCT01367574 · ClinicalTrials.gov registry record · Phase 2

Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction

A Phase 2 study, sponsored by Bausch Health Americas.

Completed
Registry status
Phase 2
Development phase
39
Enrollment target

NCT01367574: Completed Phase 2 study, sponsored by Bausch Health Americas.

NCT01367574 is a Phase 2 study that has completed, run by Bausch Health Americas. The registered enrollment target is 39 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01367574, a Phase 2 study, has completed, sponsored by Bausch Health Americas.

COMPLETED
Registry status
Phase 2
Development phase
39 participants
Enrollment target

Study Summary

This is a double-blind, randomized, parallel group, dose ranging study of subcutaneous methylnaltrexone to be conducted in patients with advanced medical illness and poorly controlled opioid induced constipation. Patients will be randomized to one of three fixed dose levels of SC MNTX.

Primary Outcome

To access the efficacy of various fixed unit doses of MNTX SC in patients with advanced medical illnesses and poorly controlled opioid-induced constipation.

Interventions

  • DRUG SC MNTX

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2002-04
Est. Completion 2003-05
Phase Phase 2
Bausch Health Americas

168 total trials

What the finished NCT01367574 record still lists

NCT01367574 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).

The record links to 0 conditions, and to 1 intervention - of which SC MNTX is the first listed.

NCT01367574 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01367574 about?

NCT01367574 is a clinical study titled "Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction". This is a double-blind, randomized, parallel group, dose ranging study of subcutaneous methylnaltrexone to be conducted in patients with advanced medical illness and poorly controlled opioid induced constipation. Patients will be randomized to one of three fixed dose levels of SC MNTX.

What is the current status of trial NCT01367574?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2002-04. Estimated completion is 2003-05.

What interventions are being tested in trial NCT01367574?

The interventions under investigation include: SC MNTX (DRUG).

Who is sponsoring clinical trial NCT01367574?

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 NCT01367574's enrollment target sits among peer trials

39 1459th of 2000 higher than 534 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01367574, the US trial registry maintained by the National Library of Medicine. NCT01367574 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.