Study of Methylnaltrexone (MNTX) for the Relief of Constipation

Phase 3CompletedNCT00402038

Bausch Health Americas, Inc.134 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

134

Conditions

Advance Illness Patients With OIC

Interventions

SC MethylnaltrexoneDRUG

Dose 1

SC PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years of age and older * Negative pregnancy test (serum or urine) at screening for all women of childbearing potential * Advanced Medical Illness (i.e., terminal illness, such as incurable cancer or end of stage AIDS) with life expectancy of ≥ 1 month * patient must sign ICF Exclusion Criteria: * Women who are pregnant and/or nursing * Previous treatment with MNTX * Participation in any other studies involving investigational products within 30 days prior to screening

Locations (1)

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, United States

Outcomes

Primary Outcomes

Laxation within four hours of a single dose of SC MNTX and efficacy of SC MNTX every other day over a 1 week period.

To determine the efficacy of a single dose of SC MNTX compared with placebo in inducing laxation within 4 hours. To determine the efficacy of SC MNTX every other day over a 1-week treatment period in relieving OIC in patients with AMI.

Time frame: 2 weeks

Data from ClinicalTrials.gov

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