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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 is a Phase 3 study that has completed, run by Bausch Health Americas. The registered enrollment target is 524 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00401375
The ClinicalTrials.gov registry entry for NCT00401375 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 524 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00401375 reports 0 study locations.
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.
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