MedPath

Methylnaltrexone

Generic Name
Methylnaltrexone
Brand Names
Relistor
Drug Type
Small Molecule
Chemical Formula
C21H26NO4
CAS Number
916055-93-1
Unique Ingredient Identifier
0RK7M7IABE
Background

Methylnaltrexone is a pheriphally-acting μ-opioid antagonist that acts on the gastrointestinal tract to decrease opioid-induced constipation without producing analgesic effects or withdrawal symptoms. It is also a weak CYP2D6 inhibitor. FDA approved in 2008.

Indication

Treatment of opioids induced constipation in palliative patients that are inadequately responding to laxative therapy.

Associated Conditions
Opioid Induced Constipation (OIC)

Methylnaltrexone for Treatment of Opiate-Induced Constipation in the Intensive Care Unit

Phase 3
Conditions
Opioid-induced Constipation
Interventions
Drug: Placebo-Normal Saline
First Posted Date
2010-01-15
Last Posted Date
2010-01-15
Lead Sponsor
St. John Health System, Michigan
Target Recruit Count
80
Registration Number
NCT01050595
Locations
🇺🇸

Providence Hospital and Medical Center, Southfield, Michigan, United States

Opioids and Esophageal Function

Phase 4
Completed
Conditions
Pharyngeal Dysfunction
Esophageal Dysfunction
Interventions
First Posted Date
2009-11-13
Last Posted Date
2011-12-09
Lead Sponsor
Region Örebro County
Target Recruit Count
13
Registration Number
NCT01012960
Locations
🇸🇪

Department of Anaesthesiology, University Hospital Örebro, Örebro, Sweden

🇸🇪

University Hospital Örebro, Örebro, Sweden

Methylnaltrexone for Opioid-induced Constipation in Cancer Patients

Phase 2
Completed
Conditions
Neoplasms
Opioid-Related Disorders
Constipation
Interventions
First Posted Date
2009-10-29
Last Posted Date
2016-02-02
Lead Sponsor
University of Vermont
Target Recruit Count
12
Registration Number
NCT01004393
Locations
🇺🇸

Fletcher Allen Health Care, Burlington, Vermont, United States

Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department?

Phase 4
Withdrawn
Conditions
Colonic Inertia
Interventions
First Posted Date
2009-07-30
Last Posted Date
2015-10-14
Lead Sponsor
Beth Israel Medical Center
Registration Number
NCT00949377

Study Evaluating the Efficacy and Safety of Subcutaneous Methylnaltrexone (MOA-728) for the Treatment of Opioid-Induced-Constipation

Phase 3
Completed
Conditions
Constipation
Interventions
First Posted Date
2009-07-10
Last Posted Date
2020-01-02
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
50
Registration Number
NCT00936884

Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects

Phase 4
Withdrawn
Conditions
Opioid-Induced Constipation
Interventions
First Posted Date
2009-03-10
Last Posted Date
2019-11-29
Lead Sponsor
Bausch Health Americas, Inc.
Registration Number
NCT00858754
Locations

Pfizer Investigational Site

Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness

Phase 4
Completed
Conditions
Opioid-Induced Constipation
Interventions
First Posted Date
2008-05-06
Last Posted Date
2018-03-07
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
156
Registration Number
NCT00672139
Locations
🇬🇧

Salix Investigational Site, Cheltenham, Gloucestershire, United Kingdom

🇲🇽

Pfizer Investigational Site, Mexico City DF, Mexico

Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness

Phase 4
Completed
Conditions
Opioid-Induced Constipation
Interventions
First Posted Date
2008-05-06
Last Posted Date
2018-03-08
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
237
Registration Number
NCT00672477
Locations
🇬🇧

Salix Investigational Site, Cheltenham, Gloucestershire, United Kingdom

🇲🇽

Pfizer Investigational Site, Mexico City DF, Mexico

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

Phase 2
Completed
Conditions
Opioid-induced Constipation
Interventions
First Posted Date
2008-03-21
Last Posted Date
2019-09-04
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
37
Registration Number
NCT00640146
Locations
🇺🇸

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

Study Evaluating MOA-728 Oral for the Treatment of OIBD in Subjects With Chronic Non-Malignant Pain

Phase 2
Completed
Conditions
Constipation
Interventions
Drug: Placebo
First Posted Date
2008-01-31
Last Posted Date
2020-08-20
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
128
Registration Number
NCT00605644
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