NCT01186770

A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Oral Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Chronic, Non-Malignant Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 804 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

MNTX 3201 is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral MNTX for the treatment of opioid induced constipation in participants with chronic, non-malignant pain.

Conditions

• Opioid-Induced Constipation

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 arms.

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-09-08
• Completion: 2011-09-08
• First posted: 2010-08-23
• Last updated: 2019-09-06
• Results posted: 2019-09-06

Locations

2 sites across 1 country: United States