drugset / Trial / NCT00528970
A Study Evaluating Intravenous (IV) MOA-728 for the Treatment of Postoperative Ileus (POI) in Participants After Ventral Hernia Repair
Phase 3
Completed
374 enrolled
Bausch Health Americas, Inc.
Progenics Pharmaceuticals, Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2007-10-17
- Primary completion
- 2008-02-05
- Completion
- 2008-02-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylnaltrexone | Other / unclassified | 12 mg | Intravenous |
| Subject | Methylnaltrexone | Other / unclassified | 24 mg | Intravenous |