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Trial record 1 of 1 for:    NCT00640146
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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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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.

Tracking Information
First Submitted Date  ICMJE March 18, 2008
First Posted Date  ICMJE March 21, 2008
Results First Submitted Date  ICMJE August 12, 2019
Results First Posted Date  ICMJE September 4, 2019
Last Update Posted Date September 4, 2019
Actual Study Start Date  ICMJE October 19, 2007
Actual Primary Completion Date January 21, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 18, 2008)
The effect of the interventional treatment will be measured by bowel movements. [ Time Frame: 1 Year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2019)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures
Official Title  ICMJE 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
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".
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Opioid-induced Constipation
Intervention  ICMJE
  • Drug: Methylnaltrexone bromide
    Methylnaltrexone will be administered as per the dose and schedule specified in the respective arm.
  • Drug: Placebo
    Placebo matching to methylnaltrexone will be administered as per the dose and schedule specified in the respective arm.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Methylnaltrexone bromide
  • 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.
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 12, 2019)
37
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2008)
260
Actual Study Completion Date  ICMJE January 21, 2009
Actual Primary Completion Date January 21, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00640146
Other Study ID Numbers  ICMJE MNTX2101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bausch Health Americas, Inc.
Study Sponsor  ICMJE Bausch Health Americas, Inc.
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Study Director: Lindsey Mathew Bausch Health Americas, Inc.
PRS Account Bausch Health Americas, Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP