Phase 2
N=37
Study of Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures
Opioid-induced Constipation
Bottom Line
View on ClinicalTrials.gov: NCT00640146 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Percentage of Participants With Laxation Response Within 2 Hours of the First Dose — 33.33; 0 percentage of participants — p=0.0213
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Methylnaltrexone bromide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Laxation Response Within 2 Hours of the First Dose |
33.33; 0 | 0.0213 sig |
| PRIMARY Percentage of Participants With Laxation Response Within 4 Hours of the First Dose |
38.89; 6.67 | 0.0463 sig |
| SECONDARY Time to First Rescue-Free Bowel Movement (Laxation) |
23.8; 46.7 | — |
Summary
The purpose of this study is to examine the safety and activity of MNTX in relieving opioid-induced constipation following orthopedic procedures.
Eligibility Criteria
Inclusion Criteria
- Male and female participants greater than or equal to (>=) 18 years of age.
- Participants must have undergone an orthopedic procedure (that is, total knee or hip replacement, spinal fusion, or reduction of fracture(s) with or without surgical fixation post trauma).
- Participants must be receiving opioid analgesics (a mu agonist only-not to include agents with mixed mechanisms of action such as tramadol or buprenorphine) after the procedures and be expected to require daily opioid analgesics for at least 7 days post randomization.
- Participants must be acutely constipated following their orthopedic procedure.
- Participants must receive all doses of study drug in either hospitals or rehabilitation facilities.
- Participants must sign an informed consent form.
- Females of childbearing potential must have a negative pregnancy test and use appropriate birth control throughout the study.
- Body weight within range of 40 kilograms (kg) - 150 kg (88 - 330 pounds [lbs]).
Exclusion Criteria
- Participants with known hypersensitivity to methylnaltrexone, naltrexone, or naloxone.
- Participants who received any investigational new drug (experimental) in the previous 30 days.
- Participants who have received a laxative (for example, lactulose) or an enema within 48 hours prior to the first dose.
- Participants with constipation not attributed to post procedure opioids.
- Participants with a history of alcohol or prescription or non-prescription drug abuse within the past 2 years.
- Female participants who are pregnant or lactating.
- Participants with a known history of chronic active hepatitis B or hepatitis C virus or human immunodeficiency virus (HIV) infection.
Data sourced from ClinicalTrials.gov (NCT00640146). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.