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

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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.


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
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Auburndale, Florida 33823
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Albuquerque, New Mexico 87108
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American Fork, Utah 84003
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Aurora, Colorado 80045
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Austin, Texas 78757
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Cleveland, Ohio 44119
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Darlinghurst, New South Wales 2010
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Flat Rock, North Carolina 28731
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Houston, Texas 77030
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Hudson, Florida 34667
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Laguna Hills, California 92637
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Lakeland, Florida 33805
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Lancaster, California 93534
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Madison, Wisconsin 53792
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Miami Springs, Florida 33166
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Mobile, Alabama 36604
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Mobile, AL
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Orange, New Jersey 07018
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Orem, Utah 84058
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Philadelphia, Pennsylvania 19111
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Provo, Utah 84604
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Ruskin, Florida 33573
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Salt Lake City, Utah 84132
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Sebring, Florida 33870
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Tampa, Florida 33619
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Temple Terrace, Florida 33617
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West Palm Beach, Florida 33407
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Winston-Salem, North Carolina 27103
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