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

November 21, 2019 updated by: Bausch Health Americas, Inc.

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

To test the effectiveness of MNTX in advanced illness subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Tarrytown, New York, United States, 10591
        • Progenics Pharmaceuticals, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: SC Methylnaltrexone
Dose 1
Drug: SC Methylnaltrexone
Dose 2
Experimental: Arm 2
Drug: SC Methylnaltrexone
Dose 1
Drug: SC Methylnaltrexone
Dose 2
Placebo Comparator: Arm 3
Drug: SC Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of SC MNTX compared with placebo in inducing laxation
Time Frame: 29 days
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.
29 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

February 1, 2005

Study Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

November 16, 2006

First Submitted That Met QC Criteria

November 17, 2006

First Posted (Estimate)

November 20, 2006

Study Record Updates

Last Update Posted (Actual)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MNTX 301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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