Clinical trials: Methylnaltrexone
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.
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.
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
Bowel Dysfunction
Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction
This is a double-blind, randomized, parallel group, dose ranging study of subcutaneous methylnaltrexone to be conducted in patients with advanced medical illness and poorly controlled opioid induced constipation.
- Trial name
- NCT01367574
- Testing
- SC MNTX
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Bausch Health Americas, Inc.
Healthy Adult Subjects
Evaluate the Pharmacokinetics (PK) of Methylnaltrexone (MNTX) in Healthy Adult Subjects
MNTX 1109 is a single center, open label study, composed of normal healthy adult subjects to evaluate the PK of MNTX and its metabolites administered once daily as a subcutaneous (SC) injection for a period of seven days.
- Trial name
- NCT01366326
- Testing
- Methylnaltrexone bromide
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
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
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.
Endogenous and Esophageal Sensitivity
The Effect of Naloxone and Methylnaltrexone on Esophageal Sensitivity in Health
The aim of this study was to investigate the effect of naloxone (IV or IM administration) and methylnaltrexone (subcutaneous administration) on esophageal sensitivity, in a group of healthy volunteers in order to evaluate the…
- Trial name
- NCT03014843
- Testing
- Naloxone, Methylnaltrexone Bromide
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Postoperative Ileus
Intravenous (IV) Methylnaltrexone (MNTX) in the Prevention of Post-Operative Ileus
A double-blind, randomized, parallel-group study designed to evaluate the safety and activity of IV MNTX in the treatment of Post-Operative Ileus (POI) in patients who underwent segmental colectomies via laparotomy.
- Trial name
- NCT01367548
- Testing
- IV Methylnaltrexone (MNTX)
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Bausch Health Americas, Inc.
Constipation
Methylnaltrexone Use for Opioid-induced Postoperative Constipation
The purpose of this study is to determine whether the routine use of methylnaltrexone in the post-operative pediatric spinal fusion patient will decrease the incidence of constipation.
- Trial name
- NCT01773096
- Testing
- Methylnaltrexone, Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Shriners Hospitals for Children
Healthy Males
Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function
This is a double-blind, randomized, study at a single clinical site investigating the effect of methylnaltrexone and naloxone versus placebo in healthy males who have received a short-acting opioid, remifentanil.
- Trial name
- NCT01367561
- Testing
- Naloxone, IV Methylnaltrexone (MNTX)
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Opioid-Induced Constipation
Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects
This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids.
- Trial name
- NCT00858754
- Testing
- methylnaltrexone
- Where
- 8 sites in United States, Canada and 2 more
- Sponsor
- Bausch Health Americas, Inc.
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
Opioid-Induced Constipation
A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain
MNTX 3201 is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral MNTX for the treatment of opioid induced constipation in…
- Trial name
- NCT01186770
- Testing
- Methylnaltrexone
- Where
- 2 sites in United States
- Volunteers
- 804 people
- Sponsor
- Bausch Health Americas, Inc.
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
Opioid-induced Constipation
Study of Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures
The purpose of this study is to examine the safety and activity of MNTX in relieving opioid-induced constipation following orthopedic procedures.
- Trial name
- NCT00640146
- Testing
- Methylnaltrexone bromide
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Bausch Health Americas, Inc.
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.
Post Operative Bowel Dysfunction
Study Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus
Primary Objective: In subjects who have undergone segmental colectomy, the time between the end of surgery and first bowel movement is significantly shorter with the investigational MOA-728 regimen than with a placebo regimen.
- Trial name
- NCT00387309
- Testing
- Methylnaltrexone (MOA-728)
- Where
- 92 sites in United States, Australia and 8 more
- Volunteers
- 495 people
- Sponsor
- Bausch Health Americas, Inc.
Intestinal Obstruction
Effects of Methylnaltrexone in Comparison to Naloxone on Loperamide-induced Delay of the Oro-cecal, Whole-gut and Colon Transit Time.
The purpose of this study is to describe the effects of repeated-dose methylnaltrexone in preventing loperamide-induced delay of whole-gut, oro-cecal and colon transit time and to measure pharmacokinetics of methylnaltrexone and…
- Trial name
- NCT01596764
- Testing
- Loperamide, Colon Transit, Sulfasalazine
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- University Medicine Greifswald