Clinical trials: Methylnaltrexone
Opioid-Induced Constipation
Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness
This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness…
- Trial name
- NCT00672139
- Testing
- Methylnaltrexone bromide
- Where
- 46 sites in United States, Australia and 8 more
- Volunteers
- 156 people
- Sponsor
- Bausch Health Americas, Inc.
Healthy Subjects
Pharmacokinetics and Bioavailability of Single Subcutaneous Doses of Methylnaltrexone Versus Intravenous Dose
This is an open-label, Phase I study. Study treatments will entail a four-way crossover among three single, ascending, subcutaneous doses and one intravenous dose of MNTX in six healthy normal male volunteers.
- Trial name
- NCT01367496
- Testing
- SC Methylnaltrexone (MNTX), IV Methylnaltrexone (MNTX)
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Healthy Adult Subjects
Effect of Cimetidine on the Single-Dose PK of IV- Administered MNTX
This open-label study assesses the single-dose pharmacokinetics of intravenously-administered MNTX in healthy adult male and female subjects in the absence of, and in the presence of, orally-administered cimetidine.
- Trial name
- NCT01366378
- Testing
- methylnaltrexone
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Constipation
Study Evaluating the Efficacy and Safety of Subcutaneous Methylnaltrexone (MOA-728) for the Treatment of Opioid-Induced-Constipation
The primary purpose of this study is to evaluate the safety, efficacy, and tolerability of subcutaneous (injection beneath the skin) MOA-728 versus placebo in adult Asian subjects with opioid-induced constipation associated with…
- Trial name
- NCT00936884
- Testing
- Methylnaltrexone
- Where
- 6 sites in South Korea, Taiwan
- Volunteers
- 50 people
- Sponsor
- Bausch Health Americas, Inc.
Coronary Artery Disease
Effect of Methylnaltrexone on the PK/PD Profiles of Ticagrelor in Patients Treated With Morphine
Ticagrelor is associated with more prompt and potent antiplatelet effects compared with clopidogrel, leading to better clinical outcomes, including reduced cardiovascular mortality, across the spectrum of patients with acute…
- Trial name
- NCT02403830
- Testing
- Methylnaltrexone, Morphine, Ticagrelor
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Florida
Healthy Adults
Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan
This study is a single-center, randomized, open-label, active and placebo-controlled, parallel-group, conducted in healthy male volunteers who have been shown to be extensive metabolizers of dextromethorphan.
- Trial name
- NCT01367535
- Testing
- SC Methylnaltrexone (MNTX), IV Methylnaltrexone (MNTX), Oral Paroxetine
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Liver Dysfunction
Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone in Volunteers With Impaired Hepatic Function
This is a multicenter, non-randomized, single-dose, parallel-group study. Each subject will receive a subcutaneous dose of MNTX.
- Trial name
- NCT01367522
- Testing
- SC Methylnaltrexone (MNTX)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Opioid-induced Constipation
Methylnaltrexone for Treatment of Opiate-Induced Constipation in the Intensive Care Unit
The purpose of this study is to determine if there will be a significantly higher incidence of a bowel movement with methylnaltrexone vs.
- Trial name
- MOVE-IT (NCT01050595)
- Testing
- Methylnaltrexone Bromide
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- St. John Health System, Michigan
Post-Operative Ileus (POI)
Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)
To evaluate the safety and efficacy of MNTX in participants who have undergone segmental colectomy and to assess if the time between the end of surgery and the first bowel movement is significantly shorter in the MNTX regimen…
- Trial name
- NCT00401375
- Testing
- Methylnaltrexone
- Where
- United States
- Volunteers
- 524 people
- Sponsor
- Bausch Health Americas, Inc.
Constipation
Methylnaltrexone for Opioid Induced Constipation
Methylnaltrexone for the treatment of opioid-induced constipation in the setting of palliative or hospice care, is significantly more effective than placebo (1).
- Trial name
- RILAX (NCT01955213)
- Testing
- methylnaltrexone
- Where
- 6 sites in Netherlands
- Volunteers
- 7 people
- Sponsor
- Amsterdam UMC, location VUmc
Ileus
A Study Evaluating Intravenous (IV) MOA-728 for the Treatment of Postoperative Ileus (POI) in Participants After Ventral Hernia Repair
This study will evaluate the safety and efficacy of two different dose regimens (12 milligrams [mg] and 24 mg) of IV MOA-728 versus placebo in shortening the time to return of bowel function in participants receiving opioid…
- Trial name
- NCT00528970
- Testing
- MOA-728
- Where
- 106 sites in United States, Australia and 9 more
- Volunteers
- 374 people
- Sponsor
- Bausch Health Americas, Inc.
Opioid Use, Unspecified With Other Opioid-induced Disorder
Methylnaltrexone Pharmacokinetics in Neurointensive Care Patients
Assessment of pharmacokinetic parameters of once daily subcutaneously administered methylnaltrexone in 10 evaluable neurointensive care patients.
- Trial name
- RELZH12 (NCT01889290)
- Testing
- Methylnaltrexone
- Where
- Switzerland
- Volunteers
- 9 people
- Sponsor
- University of Zurich
Normal Healthy Volunteers
Tolerance and Pharmacokinetics Study of MNTX Tablets
This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy volunteers. Study treatment includes single doses of MNTX and placebo.
- Trial name
- NCT01366339
- Testing
- Oral methylnaltrexone
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Opioid-induced Constipation
Compassionate Use Study of Methylnaltrexone
This is an open label compassionate use study of subcutaneously administered methylnaltrexone (MNTX) in participants with advance medical illness and opioid-induced constipation.
- Trial name
- NCT01368562
- Testing
- Methylnaltrexone
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Bausch Health Americas, Inc.
Tube Feeding
Effect of Methylnaltrexone (Relistor) on Digestion and Tolerance to Tube Feeding in Patients Treated With Opiates
It is hypothesized that using methylnaltrexone in addition to pain killer narcotics (opiates) in patients will result in increased tube feeding rates with more frequent nutrition at goal calorie rate.
- Trial name
- NCT01360372
- Testing
- Methylnaltrexone, Saline injection
- Where
- 2 sites in United States
- Sponsor
- Drexel University
Postoperative Ileus
Subcutaneous Methylnaltrexone Versus Placebo for Postoperative Ileus Prevention
This randomized controlled trial will prospectively evaluate the clinical benefit for subcutaneous methylnaltrexone (MNTX) in counteracting the obstipatory (causing constipation) effects of spinal surgery without increasing…
- Trial name
- NCT03852524
- Testing
- Methylnaltrexone
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- Ohio State University
STEMI, Morphine
Methylnaltrexone as a Method to Improve Ticagrelor Uptake in Morphine Treated STEMI Patients
This study will examine the impact of the peripheral opioid antagonist methylnaltrexone on the onset of effect of ticagrelor in morphine treated patients with ST elevation myocardial infarction (STEMI).
- Conditions
- STEMI, Morphine, Ticagrelor, Methylnaltrexone
- Trial name
- MOVEMENT (NCT02942550)
- Testing
- Methylnaltrexone bromide (Relistor®)., Sodium Chloride 9mg/mL
- Where
- 2 sites in Sweden
- Volunteers
- 82 people
- Sponsor
- Karolinska University Hospital
Gastric Motility Disorder
Effect of Methylnaltrexone on GI Transit in Healthy Volunteers
This is a single-center, randomized, double blind, placebo-controlled study evaluating the effects of placebo, codeine, methylnaltrexone and codeine with methylnaltrexone on gastrointestinal motility and colonic transit of solids…
- Trial name
- NCT01055704
- Testing
- Methylnaltrexone only, Codeine only, Methylnaltrexone + codeine
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Advanced Cancer
Dasatinib, Bevacizumab, Paclitaxel in Patients With Advanced Malignancies
The goal of this clinical research study is to find the highest tolerable dose of the combination of dasatinib, bevacizumab, and paclitaxel with or without Methylnaltrexone that can be given to patients with advanced cancer.
- Trial name
- NCT01015222
- Testing
- Dasatinib, Bevacizumab, Paclitaxel
- Where
- United States
- Volunteers
- 122 people
- Sponsor
- M.D. Anderson Cancer Center
Intestinal Obstruction
Effects of 500 mg Immediate Release and Extended Release Methylnaltrexone on Loperamide-induced Delay of the Oro-cecal and Whole-gut Transit Time in Healthy Subjects
The purpose of this study is to describe the effects of methylnaltrexone in preventing loperamide-induced delay of the oro-cecal and whole-gut transit time and measure pharmacokinetics of methylnaltrexone after subcutaneous and…
- Trial name
- LOP-MNTX-2009 (NCT01596777)
- Testing
- Loperamide, Methylnaltrexone 12 mg sc., Methylnaltrexone IR capsule
- Where
- Germany
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- University Medicine Greifswald