Trials / Completed
CompletedNCT00528970
A Study Evaluating Intravenous (IV) MOA-728 for the Treatment of Postoperative Ileus (POI) in Participants After Ventral Hernia Repair
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Intravenous Methylnaltrexone (MOA-728) for the Treatment of Post Operative Ileus After Ventral Hernia Repair
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 374 (actual)
- Sponsor
- Bausch Health Americas, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety and efficacy of two different dose regimens (12 milligrams \[mg\] and 24 mg) of IV MOA-728 versus placebo in shortening the time to return of bowel function in participants receiving opioid analgesia administered via patient-controlled anesthesia (PCA), and who had undergone repair of large (greater than or equal to \[≥\]10 centimeters) ventral hernias with or without a mesh prosthesis via laparotomy or laparoscopy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MOA-728 | MOA-728 will be administered per the dose and schedule specified in the arm. |
| DRUG | Placebo | Placebo matching to MOA-728 will be administered per the schedule specified in the arm. |
Timeline
- Start date
- 2007-10-17
- Primary completion
- 2008-02-05
- Completion
- 2008-02-05
- First posted
- 2007-09-14
- Last updated
- 2019-09-04
- Results posted
- 2019-09-04
Locations
106 sites across 11 countries: United States, Australia, Belgium, Canada, Germany, Hungary, Italy, Netherlands, Poland, South Africa, South Korea
Source: ClinicalTrials.gov record NCT00528970. Inclusion in this directory is not an endorsement.