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Health Condition(s) or Problem
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Opioid-Induced Constipation
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Lay Summary
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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.
(from ClinicalTrials.gov)
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Who can enter the trial
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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.
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Who cannot enter the trial
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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.
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What will happen
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Drug; Methylnaltrexone bromide; Methylnatrexone (either 0.2ml, 0.4ml or 0.6ml) subcutaneously every other day for 14 days (ie, 7 doses); Methylnaltrexone bromide; MOA-728; Drug; Placebo; Placebo (either 0.2ml, 0.4ml or 0.6ml) subcutaneously every other day for 14 days (ie, 7 doses); Placebo; Control
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Primary aim
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The proportion of subjects who have a rescue-free laxation response within 4 hours after at least 2 of the first 4 doses
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Secondary Aim
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Time to first recue-free laxation; 2 days; No; Proportion of subjects with rescue-free laxation within 4 hours after the first dose of study drug; 1 day; No; Proportion of subjects with rescue-free laxation within 4 or 24 hours after each dose; 14 days; No; Proportion of subjects with rescue-free laxation within 4 hours after at least 4 of the maximum 7 doses; 14 days; No; Number of laxations per week; 14 days; No; Number of rescue-free laxations per week; 14 days; No; Time to first rescue-free laxation within 4 hours; 1 day; No; Time to first rescue-free laxation within 24 hours; 1 day; No; Time to first rescue-free laxation after each dose; 14 days; No; Proportion of subjects using rescue laxatives during the double-blind period; 14 days; No; Proportion of subjects using enemas during the double-blind period; 14 days; No; Proportion of subjects having manual disimpaction procedures performed during the double-blind period; 14 days; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3200K1-4000&StudyName=Study%20Evaluating%20Subcutaneous%20Methylnaltrexone%20For%20Treatment%20Of%20Opioid-Induced%20Constipation%20In%20Patients%20With%20Advanced%20Illness
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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Cheltenham
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