A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Intravenous Methylnaltrexone (MOA-728) for the Treatment of Post Operative Ileus.

NCT00387309 Phase 3 COMPLETED

Primary Objective: In subjects who have undergone segmental colectomy, the time between the end of surgery and first bowel movement is significantly shorter with the investigational MOA-728 regimen than with a placebo regimen.

Details

Lead sponsor	Bausch Health Americas, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	495
Start date	2006-12
Completion	2007-11

Conditions

• Post Operative Bowel Dysfunction

Interventions

• Methylnaltrexone (MOA-728)

Primary outcomes

• Primary Objective: In subjects who have undergone segmental colectomy, the time between the end of surgery and first bowel movement is significantly shorter with the MOA-728 regimen than with a placebo regimen.

Countries

United States, Australia, Germany, Hungary, Italy, Poland, Romania, Serbia and Montenegro, South Africa, South Korea