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NCT00401375 · ClinicalTrials.gov registry record · Phase 3
Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)
A Phase 3 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 3
- Development phase
- 524
- Enrollment target
NCT00401375: Completed Phase 3 study, sponsored by Bausch Health Americas.
NCT00401375 is a Phase 3 study that has completed, run by Bausch Health Americas. The registered enrollment target is 524 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00401375, a Phase 3 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 524 participants
- Enrollment target
Study Summary
To evaluate the safety and efficacy of MNTX in participants who have undergone segmental colectomy and to assess if the time between the end of surgery and the first bowel movement is significantly shorter in the MNTX regimen than the equivalent assessment using a placebo regimen.
Primary Outcome
Time to first bowel movement was measured from the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). Time of the first bowel movement was recorded on the electronic case report form (eCRF). The first bowel movement was defined as a normal stool for a postoperative participant based on the clinical judgment of the investigator or designee. Analysis was performed by Kaplan-Meier estimate. Participants who had a bowel movement but were readmitte
Interventions
- DRUG Placebo
- DRUG Methylnaltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 524 participants |
| Start Date | 2006-10-31 |
| Est. Completion | 2008-02-29 |
| Phase | Phase 3 |
What the finished NCT00401375 record still lists
NCT00401375 is an interventional study that assigns participants to a tested intervention. The registered 524 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 (32% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00401375 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00401375 about?
NCT00401375 is a clinical study titled "Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)". To evaluate the safety and efficacy of MNTX in participants who have undergone segmental colectomy and to assess if the time between the end of surgery and the first bowel movement is significantly shorter in the MNTX regimen than the equivalent assessment using a placebo regimen.
What is the current status of trial NCT00401375?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 524 participants. The study started on 2006-10-31. Estimated completion is 2008-02-29.
What interventions are being tested in trial NCT00401375?
The interventions under investigation include: Placebo (DRUG), Methylnaltrexone (DRUG).
Who is sponsoring clinical trial NCT00401375?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00401375's enrollment target sits among peer trials
524 716th of 2000 higher than 1,285 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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