NCT00401375

Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)

A Phase 3, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 524 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of MNTX in participants who have undergone segmental colectomy and to assess if the time between the end of surgery and the first bowel movement is significantly shorter in the MNTX regimen than the equivalent assessment using a placebo regimen.

Conditions

• Post-Operative Ileus (POI)

Interventions

Type	Name	Description
DRUG	Methylnaltrexone	Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms.
DRUG	Placebo	Placebo matching to methylnaltrexone will be administered as per the schedule specified in the respective arm.

Timeline

• Start date: 2006-10-31
• Primary completion: 2008-02-29
• Completion: 2008-02-29
• First posted: 2006-11-20
• Last updated: 2019-09-04
• Results posted: 2019-09-04

Locations

1 site across 1 country: United States