A Study of S-297995 for the Treatment of Opioid-Induced Constipation in Subjects With Non-Malignant Chronic Pain Receiving Opioid Therapy



Status:Completed
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:August 2011
End Date:October 2012
Contact:Shionogi Clinical Trials Administrator Clinical Support Help Line
Email:shionogiclintrialsadmin@shionogi.com
Phone:800-849-9707

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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of S-297995 for the Treatment of Opioid-Induced Constipation in Subjects With Non-Malignant Chronic Pain Receiving Opioid Therapy


The purpose of this study is to determine efficacy and safety of S-297995 for the treatment
of opioid-induced constipation in subjects with non-malignant chronic pain receiving opioid
therapy for ≥3 months


Inclusion Criteria:

- Subjects aged 18 years or older at time of informed consent with non-malignant
chronic pain experiencing opioid-induced constipation

- Subjects with <3 spontaneous bowel movements a week and experiencing bowel symptoms

- Subjects receiving chronic opioid therapy due to non-malignant pain for ≥3 months

Exclusion Criteria:

- Evidence of clinically significant gastrointestinal disease

- History of chronic constipation prior to starting analgesic medication or any
potential non-opioid cause of bowel dysfunction that may be a major contributor to
the constipation

- Severe constipation that has not been appropriately managed such that the subject is
at immediate risk of developing serious complications of constipation
We found this trial at
19
sites
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Orem, UT
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Altoona, Pennsylvania
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Anaheim, California
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Atlanta, Georgia
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Atlanta, GA
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Austin, Texas
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Austin, TX
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Berlin, New Jersey
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Berlin, NJ
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Brandon, Florida
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Brandon, FL
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Columbus, Ohio
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Columbus, OH
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Eugene, Oregon
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Eugene, OR
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Evansville, Indiana
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Evansville, IN
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Greer, South Carolina
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Greer, SC
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Las Vegas, Nevada
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Las Vegas, NV
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Lexington, Kentucky
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Lexington, KY
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New York, New York
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New York, NY
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Owings Mills, Maryland
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Owings Mills, MD
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Shreveport, Louisiana
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Shreveport, LA
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Traverse City, Michigan
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Traverse City, MI
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Watertown, Massachusetts
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Watertown, MA
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Winston-Salen, North Carolina
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Winston-Salen, NC
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