Assessment of efficacy and safety in relieving opioid-induced constipation in patients with cancer-related pain

Inclusion Criteria

• - Provision of written informed consent prior to any study-specific procedures.
• - Men and women aged 18 or older.
• - Histologically or cytologically confirmed neoplasm causing pain and requiring management with opioids.
• - Self-reported active symptoms of OIC at screening (<3 RFBMs/week and experiencing >1 reported symptom of hard/lumpy stools, straining, or sensation of incomplete evacuation/anorectal obstruction in at least 25% of BMs over the previous 4 weeks); and Documented confirmed OIC (<3 RFBMs/week on average aver the 2-week OIC confirmation period.
• - Receiving a stable maintenance opioid regimen consisting of a total daily dose of >30 mg of oral morphine, or equianalgesic amount(s) of 1 or more opioid therapies for a minimum of 4 weeks prior to screening for cancer-related pain with no anticipated change in opioid dose requirement over the proposed study period as a result of disease progression.