Safety of Subcutaneous Methylnaltrexone for 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:July 2008
End Date:May 2013

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Open-Label Extension Study To Assess The Safety Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Subjects With Advanced Illness And Opioid-Induced Constipation

This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the
safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will
be tested in late stage, advanced illness patients who have constipation caused by opioid
pain relievers. This study will last 3 months.


Inclusion Criteria:

- Has completed study 3200K1-4000-WW, including 2 weeks of therapy and completion of all
post baseline efficacy, safety, and health outcomes assessments.

- Is receiving opioids on a regular schedule, not just as needed to control pain.

- Likely to continue to need treatment of OIC for the duration of participation in the
study.

Exclusion Criteria:

- Has a suspected mechanical gastrointestinal obstruction, fecal impaction, or
clinically important active diverticular disease as determined by the investigator.

- Currently using an opioid antagonist or partial antagonist.

- Has any other clinically important abnormalities such that risk to patient of
participation outweighs the potential benefit of therapy as determined by the
investigator
We found this trial at
27
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Mobile, Alabama 36604
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American Fork, Utah 84003
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Auburndale, Florida 33823
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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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Coburg, Victoria 3058
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Flat Rock, North Carolina 28731
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Houston, Texas 77030
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Houston, TX
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Hudson, Florida 34667
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Hudson, FL
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Laguna Hills, California 92637
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Lakeland, Florida 33805
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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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Miami Springs, FL
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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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Sebring, Florida 33870
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Tampa, Florida 33619
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Tampa, Florida 33619
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Tampa, Florida 33619
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Temple Terrace, Florida 33617
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Winston-Salem, North Carolina 27103
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Winston-Salem, NC
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