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A a Single Dose Efficacy Study in Inducing Laxation in Advance Illness Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Double-Blind Placebo-Controlled Study of Methylnaltrexone (MNTX) for the Relief of Constipation Due to Chronic Opioid Therapy in Patients With Advanced Medical Illness

NCT00401362•Bausch Health Americas, Inc.

View on ClinicalTrials.gov

Summary

To test the effectiveness of MNTX in advanced illness subjects.

Detailed Description

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

February 1, 2003

Primary Completion Date

February 1, 2005

Completion Date

February 1, 2005

Last Updated

November 25, 2019

Enrollment

154

ACTUAL participants

Conditions

Advanced Illness Patients With Opioid Induced Constipation

Interventions

SC Methylnaltrexone

DRUG

SC Placebo

DRUG

SC Methylnaltrexone

DRUG