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NCT01367548 · ClinicalTrials.gov registry record · Phase 2

Intravenous (IV) Methylnaltrexone (MNTX) in the Prevention of Post-Operative Ileus

A Phase 2 study, sponsored by Bausch Health Americas.

Completed
Registry status
Phase 2
Development phase
65
Enrollment target

NCT01367548: Completed Phase 2 study, sponsored by Bausch Health Americas.

NCT01367548 is a Phase 2 study that has completed, run by Bausch Health Americas. The registered enrollment target is 65 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01367548, a Phase 2 study, has completed, sponsored by Bausch Health Americas.

COMPLETED
Registry status
Phase 2
Development phase
65 participants
Enrollment target

Study Summary

A double-blind, randomized, parallel-group study designed to evaluate the safety and activity of IV MNTX in the treatment of Post-Operative Ileus (POI) in patients who underwent segmental colectomies via laparotomy.

Primary Outcome

To assess the activity of parenterally administered MNTX compared with placebo in shortening the duration of or preventing post-operative ileus in patients who have undergone segmental colectomies.

Interventions

  • DRUG Placebo
  • DRUG IV Methylnaltrexone (MNTX)

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2003-07
Est. Completion 2004-12
Phase Phase 2
Bausch Health Americas

168 total trials

What the finished NCT01367548 record still lists

NCT01367548 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower).

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

NCT01367548 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01367548 about?

NCT01367548 is a clinical study titled "Intravenous (IV) Methylnaltrexone (MNTX) in the Prevention of Post-Operative Ileus". A double-blind, randomized, parallel-group study designed to evaluate the safety and activity of IV MNTX in the treatment of Post-Operative Ileus (POI) in patients who underwent segmental colectomies via laparotomy.

What is the current status of trial NCT01367548?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2003-07. Estimated completion is 2004-12.

What interventions are being tested in trial NCT01367548?

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

Who is sponsoring clinical trial NCT01367548?

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 NCT01367548's enrollment target sits among peer trials

65 987th of 2000 higher than 1,005 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 NCT01367548, the US trial registry maintained by the National Library of Medicine. NCT01367548 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.