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 |
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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