A a Single Dose Efficacy Study in Inducing Laxation in Advance Illness Patients

Phase 3CompletedNCT00401362

Bausch Health Americas, Inc.154 enrolled

Overview

To test the effectiveness of MNTX in advanced illness subjects.

To determine the efficacy of MNTX compared to placebo to induce laxation in patients receiving opioids.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

154

Conditions

Advanced Illness Patients With Opioid Induced Constipation

Interventions

SC MethylnaltrexoneDRUG

Dose 1

SC PlaceboDRUG

SC MethylnaltrexoneDRUG

Dose 2

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Advanced medical illness with a life expectancy of 1 to 6 months 2. No clinically significant laxation within 48 hours prior to the first dose of study drug 3. On stable opioid and laxative regimen for a least 3 days prior to treatment 4. Age greater than 18years 5. Females of child-bearing age must have a negative pregnancy test. Exclusion Criteria: 1. Females who are pregnant or nursing. 2. Previous treatment with MNTX or prior treatment with naltrexone or naloxone for treatment of OIC 3. Any disease process suggestive of gastrointestinal obstruction 4. Fecal ostomy.

Locations (1)

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, United States

Outcomes

Primary Outcomes

Efficacy of SC MNTX compared with placebo in inducing laxation

The primary objective is to determine the efficacy of SC MNTX administered as a single dose, dose 1 and dose 2 compared with placebo in inducing laxation in 4 hours in patients with advanced medical illness and OIC who are poorly responsive to laxatives.

Time frame: 29 days

Data from ClinicalTrials.gov

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