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

Phase 3 Completed 804 enrolled Bausch Health Americas, Inc. Progenics Pharmaceuticals, Inc. · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2010-09-01
Primary completion: 2011-09-08
Completion: 2011-09-08

Outcome

Met primary endpoint

registry analysis (superiority test); MNTX 300 mg vs Placebo; p = 0.0016; LS mean difference 6.51 (95% CI 2.47 to 10.55); ANCOVA; NCT01186770 ↗

registry analysis (superiority test); MNTX 450 mg vs Placebo; p < 0.0001; LS mean difference 9.13 (95% CI 5.09 to 13.18); ANCOVA; NCT01186770 ↗

Publications

Liao SS, Slatkin NE, Stambler N. The Influence of Age on Central Effects of Methylnaltrexone in Patients with Opioid-Induced Constipation. Drugs Aging. 2021 Jun;38(6):503-511. doi: 10.1007/s40266-021-00850-w. Epub 2021 Mar 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methylnaltrexone	Other / unclassified	150 mg	Oral
Subject	Methylnaltrexone	Other / unclassified	300 mg	Oral
Subject	Methylnaltrexone	Other / unclassified	450 mg	Oral