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

Opioid-induced Constipation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00640146
• Other study ID #: MNTX2101
• Status: Completed
• Phase: Phase 2
• Start date: October 19, 2007
• Est. completion date: January 21, 2009

Study information

• Verified date: August 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 21, 2009
• Est. primary completion date: January 21, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Opioid-induced Constipation

Intervention

Drug:
• Methylnaltrexone bromide
Methylnaltrexone will be administered as per the dose and schedule specified in the respective arm.
• Placebo
Placebo matching to methylnaltrexone will be administered as per the dose and schedule specified in the respective arm.

Locations

Country	Name	City	State
United States	Progenics Pharmaceuticals, Inc	Tarrytown	New York

Sponsors (2)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.	Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 hours
Primary	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.	4 hours
Secondary	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.	Baseline (Day 1) up to Day 4 or 7

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