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)
Associated Therapies
-

Compassionate Use Study of Methylnaltrexone

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2011-06-08
Last Posted Date
2019-09-04
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
26
Registration Number
NCT01368562
Locations
🇺🇸

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

Evaluate the Pharmacokinetics (PK) of Methylnaltrexone (MNTX) in Healthy Adult Subjects

Phase 1
Completed
Conditions
Interventions
First Posted Date
2011-06-06
Last Posted Date
2019-11-29
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
20
Registration Number
NCT01366326
Locations
🇺🇸

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

Study of Pharmacokinetics, Safety and Tolerability of Intravenous Methylnaltrexone Bromide

Phase 1
Completed
Conditions
Interventions
First Posted Date
2011-06-06
Last Posted Date
2019-11-27
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
28
Registration Number
NCT01366365
Locations
🇺🇸

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

Effect of Cimetidine on the Single-Dose PK of IV- Administered MNTX

Phase 1
Completed
Conditions
Interventions
First Posted Date
2011-06-06
Last Posted Date
2019-11-27
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
18
Registration Number
NCT01366378
Locations
🇺🇸

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

Effect of Methylnaltrexone (Relistor) on Digestion and Tolerance to Tube Feeding in Patients Treated With Opiates

Phase 3
Withdrawn
Conditions
Interventions
First Posted Date
2011-05-25
Last Posted Date
2015-03-17
Lead Sponsor
Drexel University
Registration Number
NCT01360372
Locations
🇺🇸

Cancer Treatment Center of America, Philadelphia, Pennsylvania, United States

🇺🇸

Hahnemann University Hospital, Philadelphia, Pennsylvania, United States

A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain

First Posted Date
2010-08-23
Last Posted Date
2019-09-06
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
804
Registration Number
NCT01186770
Locations
🇺🇸

PRA International, Raleigh, North Carolina, United States

🇺🇸

PRA, Intl., Raleigh, North Carolina, United States

Methylnaltrexone vs Erythromycin for Facilitating Gastric Emptying Time in Critically Ill Patients

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2010-05-05
Last Posted Date
2011-03-31
Lead Sponsor
Shiraz University of Medical Sciences
Target Recruit Count
42
Registration Number
NCT01117376
Locations
🇮🇷

Nemazee Hospital, Shiraz, Fars, Iran, Islamic Republic of

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

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

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

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

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