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
Austin, Texas
517
mi
from
Austin, TX
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Altoona, Pennsylvania
1055
mi
from
Altoona, PA
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Anaheim, California
1155
mi
from
Anaheim, CA
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Atlanta, Georgia
801
mi
from
Atlanta, GA
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Berlin, New Jersey
1237
mi
from
Berlin, NJ
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Brandon, Florida
1123
mi
from
Brandon, FL
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Columbus, Ohio
810
mi
from
Columbus, OH
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Eugene, Oregon
1382
mi
from
Eugene, OR
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Evansville, Indiana
559
mi
from
Evansville, IN
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Greer, South Carolina
889
mi
from
Greer, SC
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Las Vegas, Nevada
960
mi
from
Las Vegas, NV
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Lexington, Kentucky
725
mi
from
Lexington, KY
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New York, New York
1286
mi
from
New York, NY
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764
mi
from
Orem, UT
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Owings Mills, Maryland
1139
mi
from
Owings Mills, MD
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Shreveport, Louisiana
428
mi
from
Shreveport, LA
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Traverse City, Michigan
796
mi
from
Traverse City, MI
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Watertown, Massachusetts
1437
mi
from
Watertown, MA
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Winston-Salen, North Carolina
976
mi
from
Winston-Salen, NC
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