Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness

February 7, 2018 updated by: Bausch Health Americas, Inc.

A Randomized, Double-Blind, Placebo-Controlled Study Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Adults With Advanced Illness And Opioid-Induced Constipation: Efficacy, Safety, And Additional Health Outcomes

This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

237

Phase

  • Phase 4

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

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Salix Investigational Site
    • Victoria
      • Coburg, Victoria, Australia, 3058
        • Salix Investigational Site
      • East Melbourne, Victoria, Australia, 3002
        • Salix Investigational Site
  • Belgium
      • Leuven, Belgium, B-3000
        • Salix Investigational Site
  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 01508-010
        • Salix Investigational Site
    • Sao Paulo
      • Liberdade, Sao Paulo, Brazil, 01509-900
        • Salix Investigational Site
  • Canada
      • Quebec, Canada, G1R 3S1
        • Salix Investigational Site
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Salix Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • Salix Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8M 1W9
        • Salix Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Salix Investigational Site
      • Montreal, Quebec, Canada, H3T 1E2
        • Salix Investigational Site
  • France
      • Besancon, France, 25030
        • Salix Investigational Site
      • Bordeaux, France, 33075
        • Salix Investigational Site
      • Bordeaux, France, 33604
        • Salix Investigational Site
      • Grenoble, France, 38043
        • Salix Investigational Site
      • Montpellier, France, 34295
        • Salix Investigational Site
      • Villejuif, France, 94804
        • Salix Investigational Site
  • Germany
      • Aachen, Germany, 52074
        • Salix Investigational Site
      • Berlin, Germany, 14089
        • Salix Investigational Site
      • Muenchen, Germany, 80336
        • Salix Investigational Site
  • Italy
      • L'Aquila, Italy, 67100
        • Salix Investigational Site
      • Milan, Italy, 20020
        • Salix Investigational Site
      • Milano, Italy, 20133
        • Salix Investigational Site
  • Mexico
      • Mexico City DF, Mexico, 03600
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • Salix Investigational Site
      • L'Hospitalet De Llobregat, Spain, 8097
        • Salix Investigational Site
      • Sevilla, Spain, 41013
        • Salix Investigational Site
  • Sweden
      • Kungsbacka, Sweden, 434 80
        • Salix Investigational Site
      • Norrköping, Sweden, 60185
        • Salix Investigational Site
  • United Kingdom
    • Gloucestershire
      • Cheltenham, Gloucestershire, United Kingdom, GL53 0Qj
        • Salix Investigational Site
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
        • Salix Investigational Site
    • California
      • Laguna Hills, California, United States, 92637
        • Salix Investigational Site
      • Lancaster, California, United States, 93534
        • Salix Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Salix Investigational Site
    • Florida
      • Auburndale, Florida, United States, 33823
        • Salix Investigational Site
      • Hudson, Florida, United States, 34667
        • Salix Investigational Site
      • Lakeland, Florida, United States, 33805
        • Salix Investigational Site
      • Lakeland, Florida, United States, 33815
        • Salix Investigational Site
      • Miami Springs, Florida, United States, 33166
        • Salix Investigational Site
      • Ruskin, Florida, United States, 33573
        • Salix Investigational Site
      • Sebring, Florida, United States, 33870
        • Salix Investigational Site
      • Tampa, Florida, United States, 33609
        • Salix Investigational Site
      • Tampa, Florida, United States, 33612-9416
        • Salix Investigational Site
      • Tampa, Florida, United States, 33619
        • Salix Investigational Site
      • Temple Terrace, Florida, United States, 33617
        • Salix Investigational Site
      • West Palm Beach, Florida, United States, 33407
        • Salix Investigational Site
    • New Jersey
      • Orange, New Jersey, United States, 07018
        • Salix Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Salix Investigational Site
    • North Carolina
      • Flat Rock, North Carolina, United States, 28731
        • Salix Investigational Site
      • Winston-Salem, North Carolina, United States, 27103-5766
        • Salix Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44119
        • Salix Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Salix Investigational Site
    • Texas
      • Austin, Texas, United States, 78757
        • Salix Investigational Site
      • Houston, Texas, United States, 77030
        • Salix Investigational Site
    • Utah
      • American Fork, Utah, United States, 84003
        • Salix Investigational Site
      • Orem, Utah, United States, 84058
        • Salix Investigational Site
      • Provo, Utah, United States, 84604
        • Salix Investigational Site
      • Salt Lake City, Utah, United States, 84112
        • Salix Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Salix Investigational Site

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:

  • Is an adult 18 years of age or older
  • Has a diagnosis of advanced illness (ie, a terminal illness such as incurable cancer or other end-stage disease)
  • Has a life expectancy of at least 1 month.
  • Is receiving opioids on a regular schedule (not just as-needed or rescue doses) for the control of pain or discomfort for at least 2 weeks before the first dose of study drug.
  • Has constipation that is caused by opioid medications.

Exclusion Criteria:

  • Has a known or suspected allergy to methylnaltrexone or other similar compounds (e.g. naltrexone or naloxone).
  • Has a known or suspected mechanical gastrointestinal obstruction.
  • Has any potential nonopioid cause of bowel dysfunction that might be a major contributor to the constipation.
  • Has any other clinically important abnormalities as determined by the investigator that may interfere with his or her participation in or compliance with the study.
  • Receiving opioid antagonist or partial antagonist products.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methylnaltrexone
Methylnaltrexone subcutaneously every other day for 14 days (ie, 7 doses). Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; or 0.4 mL (8 mg) every other day if weight between 38 and <62 kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information.
Drug: Methylnaltrexone
Other Names:
  • Relistor
  • MOA-728
Placebo Comparator: Placebo
Placebo subcutaneously every other day for 14 days (ie, 7 doses). Subjects received 0.6 mL every other day if weight ≥ 62kg; or 0.4 mL every other day if weight between 38 and < 62 kg. Subjects with impaired kidney function received reduced volumes of placebo solution to match the volumes used in the experimental group.
Drug: Placebo
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Proportion of Subjects Who Have a Rescue-free Laxation Response Within 4 Hours After at Least 2 of the First 4 Doses
Time Frame: 7 days
This outcome measures the proportion of subjects who had a rescue-free laxation (ie, bowel movement) within 4 hours after at least 2 of the first 4 doses of study drug. A "rescue free" laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Rescue-free Laxation (Following the First Dose of Study Drug).
Time Frame: 14 days
This outcome measures the time from first dose of study drug to the first rescue-free laxation (ie, bowel movement). A "rescue free" laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation.
14 days

Collaborators and Investigators

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

Sponsor

Bausch Health Americas, Inc.

Collaborators

Progenics Pharmaceuticals, Inc.

Investigators

  • Study Director: Enoch Bortey, Bausch Health Americas, Inc.

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

June 1, 2008

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

May 2, 2008

First Submitted That Met QC Criteria

May 5, 2008

First Posted (Estimate)

May 6, 2008

Study Record Updates

Last Update Posted (Actual)

March 8, 2018

Last Update Submitted That Met QC Criteria

February 7, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3200K1-4000
  • B2541005

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.

Clinical Trials on Opioid-Induced Constipation

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe