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

NCT00640146 | Completed Phase 2 Results

• 1 other identifier: MNTX2101
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Opioid-induced Constipation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Time to First Rescue-Free Bowel Movement (Laxation)

  Baseline (Day 1) up to Day 4 or 7

Study Arms (2)

MNTX

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Methylnaltrexone bromide DRUG

Methylnaltrexone will be administered as per the dose and schedule specified in the respective arm.

MNTX

Placebo DRUG

Placebo matching to methylnaltrexone will be administered as per the dose and schedule specified in the respective arm.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

Progenics Pharmaceuticals, Inc

Tarrytown, New York, 10591, United States

Location

Related Publications (1)

• 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.

  PMID: 21998076 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Opioid-Induced Constipation

Interventions

methylnaltrexone

Condition Hierarchy (Ancestors)

Constipation; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Bausch Health Americas, Inc

Lindsey.Mathew@bauschhealth.com

Study Officials

• Lindsey Mathew

  Bausch Health Americas, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2008
• First Posted: March 21, 2008
• Study Start: October 19, 2007
• Primary Completion: January 21, 2009
• Study Completion: January 21, 2009
• Last Updated: September 4, 2019
• Results First Posted: September 4, 2019

Record last verified: 2019-08

Locations

US (1)