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NCT00387309 · ClinicalTrials.gov registry record · Phase 3

Study Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus

A Phase 3 study of Post Operative Bowel Dysfunction, sponsored by Bausch Health Americas.

Completed
Registry status
Phase 3
Development phase
495
Enrollment target
20
Study locations

NCT00387309: Completed Phase 3 study of Post Operative Bowel Dysfunction, sponsored by Bausch Health Americas.

NCT00387309 is a Phase 3 study of Post Operative Bowel Dysfunction that has completed, run by Bausch Health Americas. The registered enrollment target is 495 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00387309, a Phase 3 study of Post Operative Bowel Dysfunction, has completed, sponsored by Bausch Health Americas.

COMPLETED
Registry status
Phase 3
Development phase
495 participants
Enrollment target
20
Study locations

Study Summary

Primary Objective: In subjects who have undergone segmental colectomy, the time between the end of surgery and first bowel movement is significantly shorter with the investigational MOA-728 regimen than with a placebo regimen.

Interventions

  • DRUG Methylnaltrexone (MOA-728)

Study Locations (20)

California

  • - Chula Vista
  • - Colton
  • - Los Angeles
  • - Oceanside
  • - Palo Alto
  • - San Jose
  • - Torrance

Florida

  • - Bay Minette
  • - Jacksonville
  • - Melbourne
  • - Naples
  • - St. Petersburg
  • - Vero Beach
  • - Weston

Georgia

  • - Atlanta
  • - Atlanta

Alabama

  • - Mobile

Arkansas

  • - Fort Smith

Colorado

  • - Denver

District of Columbia

  • - Washington D.C.

Trial Details

FieldValue
Enrollment Target 495 participants
Start Date 2006-12
Est. Completion 2007-11
Phase Phase 3
Bausch Health Americas

168 total trials

What the finished NCT00387309 record still lists

NCT00387309 is an interventional study that assigns participants to a tested intervention. The registered 495 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 (36% lower).

The record links to 1 condition, with Post Operative Bowel Dysfunction appearing as the primary indexed condition, and to 1 intervention - of which Methylnaltrexone (MOA-728) is the first listed.

NCT00387309 names 20 study sites across 7 states, led by California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT00387309 about?

NCT00387309 is a clinical study titled "Study Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus". Primary Objective: In subjects who have undergone segmental colectomy, the time between the end of surgery and first bowel movement is significantly shorter with the investigational MOA-728 regimen than with a placebo regimen.

What is the current status of trial NCT00387309?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 495 participants. The study started on 2006-12. Estimated completion is 2007-11.

What conditions does trial NCT00387309 study?

This clinical trial studies the following conditions: Post Operative Bowel Dysfunction.

What interventions are being tested in trial NCT00387309?

The interventions under investigation include: Methylnaltrexone (MOA-728) (DRUG).

Who is sponsoring clinical trial NCT00387309?

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

Where is trial NCT00387309 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT00387309's enrollment target sits among peer trials

495 778th of 2000 higher than 1,222 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 NCT00387309, the US trial registry maintained by the National Library of Medicine. NCT00387309 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.