A Study Evaluating Intravenous (IV) MOA-728 for the Treatment of Postoperative Ileus (POI) in Participants After Ventral Hernia Repair

• Status: Completed
• Trial end date: 2008-02-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Collaborator: Progenics Pharmaceuticals, Inc.
• Treatments: Methylnaltrexone

Criteria

Inclusion Criteria:

• Males and females, ages 18 and older.

• Scheduled for ventral wall hernia repair with general anesthesia.

• Meets the American Society of Anesthesiologists physical status I, II, or III.

Exclusion Criteria:

• Received investigational drug or procedure within 30 days of randomization.

• Women who are pregnant or lactating.

• Calculated creatinine clearance (Cockcroft-Gault glomerular filtration rate [GFR] formula) less than or equal to (