A phase 3, multicenter, open-label study of naldemedine in cancer patients with opioid-induced constipation - extension study
Phase 3
- Conditions
- Cancer patients with opioid-induced constipation (OIC)
- Registration Number
- JPRN-jRCT2080222293
- Lead Sponsor
- SHIONOGI & CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Patients who participated in the phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of naldemedine in cancer patients with opioid-induced constipation and completed the treatment period, etc.
Exclusion Criteria
Patients with constipation potentially attributable to causes other than opioid analgesics
Patients with hepatic or renal disorders, etc
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety (Adverse events)
- Secondary Outcome Measures
Name Time Method Efficacy (Assessments of Constipation Symptoms and QOL)