Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness
Opioid-Induced Constipation
About this trial
This is an interventional treatment trial for Opioid-Induced Constipation focused on measuring opioid-induced constipation
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.
Sites / Locations
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
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- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Pfizer Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
- Salix Investigational Site
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Methylnaltrexone
Placebo
Methylnaltrexone subcutaneously every other day for 14 days (ie, 7 doses). Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; or 0.4 mL (8 mg) every other day if weight between 38 and <62 kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information.
Placebo subcutaneously every other day for 14 days (ie, 7 doses). Subjects received 0.6 mL every other day if weight ≥ 62kg; or 0.4 mL every other day if weight between 38 and < 62 kg. Subjects with impaired kidney function received reduced volumes of placebo solution to match the volumes used in the experimental group.