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

Completed · Phase 3 · Has a placebo group

Conditions studied: Ileus

In brief

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.

Key facts

Study ID

NCT00528970

Run by

Bausch Health Americas, Inc.

People needed

374

Starts

2007-10-17

Expected to finish

2008-02-05

Last updated by the study team

2019-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 (</=) 50 milliliters/minute (mL/min).

Where it is running

• Study site — Colton, California, United States
• Study site — Laguna Hills, California, United States
• Study site — Loma Linda, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Orange, California, United States
• Study site — San Jose, California, United States
• Study site — Santa Barbara, California, United States
• Study site — Denver, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Inverness, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Melbourne, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Naples, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Pensacola, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Peoria, Illinois, United States
• Study site — Des Moines, Iowa, United States
• Study site — Kansas City, Kansas, United States
• Study site — Lexington, Kentucky, United States
• Study site — Benton, Arkansas, United States

Full record on ClinicalTrials.gov

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