Phase 4
Completed N=230
Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness
Opioid-Induced Constipation
Source: ClinicalTrials.gov NCT00672477 ↗
Enrolled (actual)
230
Serious AEs
16.5%
Results posted
Mar 2018
Primary outcomePrimary: 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
◆ Published Evidence
Established
94citations · ~9 / year
Treatment with methylnaltrexone is associated with increased survival in patients with advanced cancer.
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.
Linked Publications (2)
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Treatment with methylnaltrexone is associated with increased survival in patients with advanced cancer.
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The Influence of Age on Central Effects of Methylnaltrexone in Patients with Opioid-Induced Constipation.
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 |
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) and the linked publication. 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. Informational only — not medical advice.