Study of Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures

August 12, 2019 updated by: Bausch Health Americas, Inc.

A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled Phase 2 Study of Once-Daily Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures

The purpose of this study is to examine the safety and activity of MNTX in relieving opioid-induced constipation following orthopedic procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a double-blind, randomized, parallel-group, placebo- controlled Phase 2 study to evaluate the safety and activity of subcutaneous (SC) MNTX versus SC placebo in participants who have undergone orthopedic procedures and who are expected to require opioids for 1 week after randomization. Participants will sign an informed consent form and be screened between Days 4-10 after their orthopedic procedure. Those participants who meet all eligibility requirements will be enrolled in the study. Treatment with study medication will be continued until either the participant no longer requires opioid medication for pain relief or the maximum number of doses is reached. Originally, participants were receiving treatment for up to 7 days. Then after Protocol Amendment 1 (12 March 2008), the duration of treatment changed from "up to 7 days" to "up to 4 days".

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2

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. Male and female participants greater than or equal to (>=) 18 years of age.
  2. Participants must have undergone an orthopedic procedure (that is, total knee or hip replacement, spinal fusion, or reduction of fracture(s) with or without surgical fixation post trauma).
  3. Participants must be receiving opioid analgesics (a mu agonist only-not to include agents with mixed mechanisms of action such as tramadol or buprenorphine) after the procedures and be expected to require daily opioid analgesics for at least 7 days post randomization.
  4. Participants must be acutely constipated following their orthopedic procedure.
  5. Participants must receive all doses of study drug in either hospitals or rehabilitation facilities.
  6. Participants must sign an informed consent form.
  7. Females of childbearing potential must have a negative pregnancy test and use appropriate birth control throughout the study.
  8. Body weight within range of 40 kilograms (kg) - 150 kg (88 - 330 pounds [lbs]).

Exclusion Criteria:

  1. Participants with known hypersensitivity to methylnaltrexone, naltrexone, or naloxone.
  2. Participants who received any investigational new drug (experimental) in the previous 30 days.
  3. Participants who have received a laxative (for example, lactulose) or an enema within 48 hours prior to the first dose.
  4. Participants with constipation not attributed to post procedure opioids.
  5. Participants with a history of alcohol or prescription or non-prescription drug abuse within the past 2 years.
  6. Female participants who are pregnant or lactating.
  7. Participants with a known history of chronic active hepatitis B or hepatitis C virus or human immunodeficiency virus (HIV) infection.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MNTX
Participants will receive methylnaltrexone (MNTX) 12 milligrams (mg) subcutaneously (SC) once daily for up to 4 or 7 days, depending upon the protocol version under which each participant is enrolled.
Drug: Methylnaltrexone bromide
Methylnaltrexone will be administered as per the dose and schedule specified in the respective arm.
Placebo Comparator: Placebo
Participants will receive placebo matching to MNTX SC once daily for up to 4 or 7 days, depending upon the protocol version under which each participant is enrolled.
Drug: Placebo
Placebo matching to methylnaltrexone will be administered as per the dose and schedule specified in the respective arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Laxation Response Within 2 Hours of the First Dose
Time Frame: 2 hours
Percentage of participants who had a laxation (that is, bowel movement) within 2 hours after the first dose of study drug, were reported. Participants taking stool softeners within 24 hours of study drug dosing and participants taking rescue laxative medications within 48 hours of study drug dosing were assessed as treatment failures.
2 hours
Percentage of Participants With Laxation Response Within 4 Hours of the First Dose
Time Frame: 4 hours
Percentage of participants who had a laxation (that is, bowel movement) within 4 hours after the first dose of study drug, were reported. Participants taking stool softeners within 24 hours of study drug dosing and participants taking rescue laxative medications within 48 hours of study drug dosing were assessed as treatment failures.
4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Rescue-Free Bowel Movement (Laxation)
Time Frame: Baseline (Day 1) up to Day 4 or 7
A rescue-free laxation was defined as a laxation without use of any rescue medication or rescue procedures. Time to first rescue-free bowel movement following the first dose of study drug was reported.
Baseline (Day 1) up to Day 4 or 7

Collaborators and Investigators

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

Sponsor

Bausch Health Americas, Inc.

Collaborators

Wyeth is now a wholly owned subsidiary of 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

Helpful Links

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 (Actual)

October 19, 2007

Primary Completion (Actual)

January 21, 2009

Study Completion (Actual)

January 21, 2009

Study Registration Dates

First Submitted

March 18, 2008

First Submitted That Met QC Criteria

March 18, 2008

First Posted (Estimate)

March 21, 2008

Study Record Updates

Last Update Posted (Actual)

September 4, 2019

Last Update Submitted That Met QC Criteria

August 12, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MNTX2101

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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