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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00640146
Recruitment Status : Completed
First Posted : March 21, 2008
Results First Posted : September 4, 2019
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

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

Condition or disease Intervention/treatment Phase
Opioid-induced Constipation Drug: Methylnaltrexone bromide Drug: Placebo Phase 2

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".

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 19, 2007
Actual Primary Completion Date : January 21, 2009
Actual Study Completion Date : January 21, 2009

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00640146


Locations
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United States, New York
Progenics Pharmaceuticals, Inc
Tarrytown, New York, United States, 10591
Sponsors and Collaborators
Bausch Health Americas, Inc.
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Lindsey Mathew Bausch Health Americas, Inc.
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT00640146    
Other Study ID Numbers: MNTX2101
First Posted: March 21, 2008    Key Record Dates
Results First Posted: September 4, 2019
Last Update Posted: September 4, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Bromides
Methylnaltrexone
Anticonvulsants
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents