Status:
COMPLETED
A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy
Lead Sponsor:
Shionogi
Conditions:
Opioid-induced Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine efficacy and safety of naldemedine for the treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving opioid therapy for ≥ 3...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 17 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2012
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT01443403
Start Date
August 17 2011
End Date
August 22 2012
Last Update
June 26 2017
Active Locations (49)
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1
Shionogi Research Site
Phoenix, Arizona, United States
2
Shionogi Research Site
Sun Lakes, Arizona, United States
3
Shionogi Research Site
Little Rock, Arkansas, United States
4
Shionogi Research Site
Anaheim, California, United States