Status:
COMPLETED
Study of Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures
Lead Sponsor:
Bausch Health Americas, Inc.
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Opioid-induced Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 19 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2009
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00640146
Start Date
October 19 2007
End Date
January 21 2009
Last Update
September 4 2019
Active Locations (1)
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1
Progenics Pharmaceuticals, Inc
Tarrytown, New York, United States, 10591