NCT00640146

Study of Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures

A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled Phase 2 Study of Once-Daily Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the safety and activity of MNTX in relieving opioid-induced constipation following orthopedic procedures.

Detailed description

This is a double-blind, randomized, parallel-group, placebo- controlled Phase 2 study to evaluate the safety and activity of subcutaneous (SC) MNTX versus SC placebo in participants who have undergone orthopedic procedures and who are expected to require opioids for 1 week after randomization. Participants will sign an informed consent form and be screened between Days 4-10 after their orthopedic procedure. Those participants who meet all eligibility requirements will be enrolled in the study. Treatment with study medication will be continued until either the participant no longer requires opioid medication for pain relief or the maximum number of doses is reached. Originally, participants were receiving treatment for up to 7 days. Then after Protocol Amendment 1 (12 March 2008), the duration of treatment changed from "up to 7 days" to "up to 4 days".

Conditions

• Opioid-induced Constipation

Interventions

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

Timeline

• Start date: 2007-10-19
• Primary completion: 2009-01-21
• Completion: 2009-01-21
• First posted: 2008-03-21
• Last updated: 2019-09-04
• Results posted: 2019-09-04

Locations

1 site across 1 country: United States