Phase 4
N=230
Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness
Opioid-Induced Constipation
Bottom Line
View on ClinicalTrials.gov: NCT00672477 ↗Enrolled (actual)
230
Serious AEs
16.5%
Results posted
Mar 2018
Primary outcome: Primary: The Proportion of Subjects Who Have a Rescue-free Laxation Response Within 4 Hours After at Least 2 of the First 4 Doses — 62.9; 9.6 percentage of participants — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Methylnaltrexone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Subjects Who Have a Rescue-free Laxation Response Within 4 Hours After at Least 2 of the First 4 Doses |
62.9; 9.6 | < 0.0001 sig |
| SECONDARY Time to First Rescue-free Laxation (Following the First Dose of Study Drug). |
0.79; 23.58 | < 0.0001 sig |
Summary
This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these subjects.
Eligibility Criteria
Inclusion Criteria
- Is an adult 18 years of age or older
- Has a diagnosis of advanced illness (ie, a terminal illness such as incurable cancer or other end-stage disease)
- Has a life expectancy of at least 1 month.
- Is receiving opioids on a regular schedule (not just as-needed or rescue doses) for the control of pain or discomfort for at least 2 weeks before the first dose of study drug.
- Has constipation that is caused by opioid medications.
Exclusion Criteria
- Has a known or suspected allergy to methylnaltrexone or other similar compounds (e.g. naltrexone or naloxone).
- Has a known or suspected mechanical gastrointestinal obstruction.
- Has any potential nonopioid cause of bowel dysfunction that might be a major contributor to the constipation.
- Has any other clinically important abnormalities as determined by the investigator that may interfere with his or her participation in or compliance with the study.
- Receiving opioid antagonist or partial antagonist products.
Data sourced from ClinicalTrials.gov (NCT00672477). 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.