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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 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. The trial reports 20 study locations across 7 states.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 495 participants |
| Start Date | 2006-12 |
| Est. Completion | 2007-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00387309
The ClinicalTrials.gov registry entry for NCT00387309 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 495 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 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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.