Methylnaltrexone

Generic Name: Methylnaltrexone

Brand Names: Relistor

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₂₆NO_₄

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: -

Clinical Trials

Methylnatrexone In Resectable Head and Neck Squamous Cell Carcinoma (MINK). A "Window of Opportunity" Pilot Study.

Phase 4

Recruiting

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Methylnaltrexone

First Posted Date: 2023-12-08

Last Posted Date: 2024-07-19

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 25

Registration Number: NCT06162377

Locations: 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States

A Study of Methylnaltrexone Bromide (MNTX) in Participants With Advanced Pancreatic Cancer

Phase 2

Withdrawn

Conditions: Pancreatic Cancer

Interventions: Drug: Placebo
Drug: Methylnaltrexone bromide

First Posted Date: 2019-09-10

Last Posted Date: 2021-05-07

Lead Sponsor: Bausch Health Americas, Inc.

Registration Number: NCT04083651

Locations: 🇺🇸
Bausch Site 001, Omaha, Nebraska, United States

Subcutaneous Methylnaltrexone Versus Placebo for Postoperative Ileus Prevention

Phase 2

Completed

Conditions: Postoperative Ileus

Interventions: Other: Placebo
Drug: Methylnaltrexone

First Posted Date: 2019-02-25

Last Posted Date: 2021-10-27

Lead Sponsor: Ohio State University

Target Recruit Count: 82

Registration Number: NCT03852524

Locations: 🇺🇸
Ohio State University, Columbus, Ohio, United States

The Effect of Naloxone and Methylnaltrexone on Esophageal Sensitivity in Health

Not Applicable

Completed

Conditions: Endogenous and Esophageal Sensitivity

Interventions: Other: Placebo
Drug: Naloxone
Drug: Methylnaltrexone Bromide

First Posted Date: 2017-01-09

Last Posted Date: 2017-01-09

Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Target Recruit Count: 12

Registration Number: NCT03014843

Naloxegol to Prevent Lower Gastrointestinal Paralysis in Critically Ill Adults Administered Opioids

Phase 4

Terminated

Conditions: Constipation

Interventions: Drug: Placebo Oral Tablet
Drug: Naloxegol Oral Tablet
Drug: Docusate Sodium 100 Mg oral capsule [Colace]
Drug: Senna 217 Mg Oral Tablet
Drug: Polyethylene Glycols
Drug: Bisacodyl 10 mg Suppository
Drug: Magnesium Citrate Oral Liquid Product
Drug: Methylnaltrexone

First Posted Date: 2016-11-30

Last Posted Date: 2023-02-16

Lead Sponsor: Tufts Medical Center

Target Recruit Count: 12

Registration Number: NCT02977286

Locations: 🇺🇸
Tufts Medical Center, Boston, Massachusetts, United States

Effect of Methylnaltrexone on the PK/PD Profiles of Ticagrelor in Patients Treated With Morphine

Phase 4

Completed

Conditions: Coronary Artery Disease

Interventions: Other: Placebo
Drug: Methylnaltrexone
Drug: Morphine
Drug: Ticagrelor

First Posted Date: 2015-03-31

Last Posted Date: 2017-05-30

Lead Sponsor: University of Florida

Target Recruit Count: 30

Registration Number: NCT02403830

Locations: 🇺🇸
University of Florida, Jacksonville, Florida, United States

Methylnaltrexone for Opioid Induced Constipation

Terminated

Conditions: Constipation

Interventions: Drug: methylnaltrexone

First Posted Date: 2013-10-07

Last Posted Date: 2019-08-05

Lead Sponsor: Amsterdam UMC, location VUmc

Target Recruit Count: 7

Registration Number: NCT01955213

Locations: 🇳🇱
VU University Medical Center, Amsterdam, Netherlands
🇳🇱
Hospice Demeter, De Bilt, Netherlands
🇳🇱
Medical Center Alkmaar, Alkmaar, Netherlands

and more 3 locations

Methylnaltrexone Pharmacokinetics in Neurointensive Care Patients

Phase 1

Completed

Conditions: Opioid Use, Unspecified With Other Opioid-induced Disorder

Interventions: Drug: Methylnaltrexone

First Posted Date: 2013-06-28

Last Posted Date: 2016-10-26

Lead Sponsor: University of Zurich

Target Recruit Count: 9

Registration Number: NCT01889290

Locations: 🇨🇭
Neurointensive Care Unit, Zurich, Switzerland

Methylnaltrexone Use for Opioid-induced Postoperative Constipation

Phase 4

Completed

Conditions: Constipation

Interventions: Drug: Methylnaltrexone
Drug: Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax

First Posted Date: 2013-01-23

Last Posted Date: 2015-05-19

Lead Sponsor: Shriners Hospitals for Children

Target Recruit Count: 60

Registration Number: NCT01773096

Locations: 🇺🇸
Shriners Hospitals for Children- Spokane, Spokane, Washington, United States

Effects of Methylnaltrexone in Comparison to Naloxone on Loperamide-induced Delay of the Oro-cecal, Whole-gut and Colon Transit Time.

Phase 1

Completed

Conditions: Intestinal Obstruction

Interventions: Drug: Loperamide placebo
Drug: Loperamide
Device: Colon Transit
Drug: Sulfasalazine
Drug: Placebo of MNTX and NLX
Drug: Methylnaltrexone
Drug: Naloxone

First Posted Date: 2012-05-11

Last Posted Date: 2012-05-11

Lead Sponsor: University Medicine Greifswald

Target Recruit Count: 16

Registration Number: NCT01596764

Locations: 🇩🇪
Department of Clinical Pharmacology, Ernst-Moritz-Arndt-University Greifswald, Greifswald, Mecklenburg-Vorpommern, Germany

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