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

Completed · Phase 2 · Has a placebo group

Conditions studied: Opioid-induced Constipation

In brief

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

Key facts

Study ID

NCT00640146

Run by

Bausch Health Americas, Inc.

People needed

37

Starts

2007-10-19

Expected to finish

2009-01-21

Last updated by the study team

2019-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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]).

You may not qualify if…

• 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.

Where it is running

• Progenics Pharmaceuticals, Inc — Tarrytown, New York, United States

Full record on ClinicalTrials.gov

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