NCT00402038

Study of Methylnaltrexone (MNTX) for the Relief of Constipation

A Double-Blind, Phase 3, Two-Week, Placebo Controlled Study of Methylnaltrexone(MNTX) for the Relief of Constipation Due to Opioid Therapy in Advance Medical Illness.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in patients with advanced medical illness.

Detailed description

This is a multi-center, double-blind, randomized parallel group study conducted in patients with advanced medical illness and opioid-induced constipation. Eligible patients are randomly assigned to receive SC doses of either MNTX, dose 1 or placebo every other day for 2 weeks. At Day 8, eligible patients, if allowed, could be escalated to a a higher dose of MNTX.

Conditions

• Advance Illness Patients With OIC

Interventions

Type	Name	Description
DRUG	SC Methylnaltrexone	Dose 1
DRUG	SC Placebo

Timeline

• Start date: 2004-02-01
• Primary completion: 2005-10-01
• Completion: 2005-10-01
• First posted: 2006-11-22
• Last updated: 2019-11-25

Locations

1 site across 1 country: United States