Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation

Exclusion Criteria

• •1. Evidence of significant structural abnormalities of the gastrointestinal (GI) tract
• •2. Evidence of active medical diseases affecting bowel transit
• •3. History or presence of pelvic disorders that may be a cause of constipation
• •4. Surgery (except for minor procedures) within 60 days of Screening
• •5. 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 (e.g., mechanical GI obstruction)
• •6. Subjects who have never taken laxatives for the treatment of OIC
• •7. History of active treatment for cancer within the last 2 years (except for basal cell or squamous cell carcinoma of the skin that have been successfully resected) or tamoxifen \[Nolvadex®\] and raloxifene \[Evista®\] when being used for prevention of breast cancer
• •8. Current use of any prohibited medication including opioid antagonists, partial agonists or mixed agonists/antagonists