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

Primary Purpose

Opioid-induced Constipation

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Methylnaltrexone bromide
Placebo
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-induced Constipation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Progenics Pharmaceuticals, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MNTX

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants With Laxation Response Within 2 Hours of the First Dose
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.
Percentage of Participants With Laxation Response Within 4 Hours of the First Dose
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.

Secondary Outcome Measures

Time to First Rescue-Free Bowel Movement (Laxation)
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.

Full Information

First Posted
March 18, 2008
Last Updated
August 12, 2019
Sponsor
Bausch Health Americas, Inc.
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00640146
Brief Title
Study of Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 19, 2007 (Actual)
Primary Completion Date
January 21, 2009 (Actual)
Study Completion Date
January 21, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-induced Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MNTX
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Methylnaltrexone bromide
Intervention Description
Methylnaltrexone will be administered as per the dose and schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching to methylnaltrexone will be administered as per the dose and schedule specified in the respective arm.
Primary Outcome Measure Information:
Title
Percentage of Participants With Laxation Response Within 2 Hours of the First Dose
Description
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.
Time Frame
2 hours
Title
Percentage of Participants With Laxation Response Within 4 Hours of the First Dose
Description
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.
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Time to First Rescue-Free Bowel Movement (Laxation)
Description
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.
Time Frame
Baseline (Day 1) up to Day 4 or 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female participants greater than or equal to (>=) 18 years of age. 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). 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. Participants must be acutely constipated following their orthopedic procedure. Participants must receive all doses of study drug in either hospitals or rehabilitation facilities. Participants must sign an informed consent form. Females of childbearing potential must have a negative pregnancy test and use appropriate birth control throughout the study. Body weight within range of 40 kilograms (kg) - 150 kg (88 - 330 pounds [lbs]). Exclusion Criteria: Participants with known hypersensitivity to methylnaltrexone, naltrexone, or naloxone. Participants who received any investigational new drug (experimental) in the previous 30 days. Participants who have received a laxative (for example, lactulose) or an enema within 48 hours prior to the first dose. Participants with constipation not attributed to post procedure opioids. Participants with a history of alcohol or prescription or non-prescription drug abuse within the past 2 years. Female participants who are pregnant or lactating. Participants with a known history of chronic active hepatitis B or hepatitis C virus or human immunodeficiency virus (HIV) infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsey Mathew
Organizational Affiliation
Bausch Health Americas, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Progenics Pharmaceuticals, Inc
City
Tarrytown
State/Province
New York
ZIP/Postal Code
10591
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21998076
Citation
Anissian L, Schwartz HW, Vincent K, Vincent HK, Carpenito J, Stambler N, Ramakrishna T. Subcutaneous methylnaltrexone for treatment of acute opioid-induced constipation: phase 2 study in rehabilitation after orthopedic surgery. J Hosp Med. 2012 Feb;7(2):67-72. doi: 10.1002/jhm.943. Epub 2011 Oct 13.
Results Reference
derived
Links:
URL
http://www.progenics.com
Description
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Study of Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures

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