A Study Evaluating Intravenous (IV) MOA-728 for the Treatment of Postoperative Ileus (POI) in Participants After Ventral Hernia Repair
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
Outcome
Missed primary endpoint
registry analysis (other test); MOA-728 12 mg vs Placebo; p = 0.944; Mean Difference (Final Values) 2.0; Log Rank; note: Threshold for significance at 0.05 level. NCT00528970 ↗
registry analysis (other test); MOA-728 24 mg vs Placebo; p = 0.208; Mean Difference (Final Values) 9.1; Log Rank; note: Threshold for significance at 0.05 level. NCT00528970 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylnaltrexone | Other / unclassified | 12 mg | Intravenous |
| Subject | Methylnaltrexone | Other / unclassified | 24 mg | Intravenous |