Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness
Status: | Completed |
---|---|
Conditions: | Constipation |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/17/2018 |
Start Date: | June 2008 |
End Date: | February 2013 |
A Randomized, Double-Blind, Placebo-Controlled Study Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Adults With Advanced Illness And Opioid-Induced Constipation: Efficacy, Safety, And Additional Health Outcomes
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.
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.
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.
We found this trial at
27
sites
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