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
Brandon, Florida
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Altoona, Pennsylvania
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Altoona, PA
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Anaheim, California
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Anaheim, CA
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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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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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Orem, UT
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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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