Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction

Bausch Health Americas, Inc.39 enrolled

Overview

This is a double-blind, randomized, parallel group, dose ranging study of subcutaneous methylnaltrexone to be conducted in patients with advanced medical illness and poorly controlled opioid induced constipation. Patients will be randomized to one of three fixed dose levels of SC MNTX.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bowel Dysfunction

Interventions

SC MNTXDRUG

Dose 1

SC MNTXDRUG

Dose 2

SC MNTXDRUG

Dose 3

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Must have advanced medical illness (cancer, HIV, etc) and be receiving palliative care 2. Must be on opioid medication for at least 2 weeks with no expectation of significant change in regimen 3. Must have constipation 4. Must be 18 yrs or older Exclusion Criteria: 1. Concurrent use of medications other than opioids which might interfere with gastrointestinal motility 2. Patients who received any experimental drug in the last 30 days 3. Patients with active peritoneal cancer (ovarian, etc.) 4. Patients with active diverticulitis or diverticulosis

Locations (1)

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, United States

Outcomes

Primary Outcomes

Number of subjects who have a bowel movement within four hours of dosing

To access the efficacy of various fixed unit doses of MNTX SC in patients with advanced medical illnesses and poorly controlled opioid-induced constipation.

Time frame: Up to 4 weeks

Secondary Outcomes

Number of subject with Adverse Events

To access the tolerability of various fixed unit doses of MNTX SC in patients with advanced medical illnesses and poorly controlled opioid-induced constipation.

Time frame: Up to 4 weeks

Data from ClinicalTrials.gov

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