Confirmatory study of TA-8317 in patients with cancer breakthrough pain Open-label, crossover, comparative study using a comparator, morphine used as rescue medicatio
Phase 3
- Conditions
- Cancer breakthrough pain
- Registration Number
- JPRN-jRCT2080220301
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
(Inclusion criteria)
Patients who are 20 years old or older.
Patients who are diagnosed and notified to have cancer.
Patients who are treated for persistent cancer pain with opioid analgesics and whose breakthrough pain is controlled with rescue morphine administration , etc.
(Exclusion criteria)
Patients with pain that is difficult to control with opioid analgesics.
Patient's performance status scale (PS) is grade 4.
Patients with moderate to severe stomatitis , etc.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy (Pain relief score etc) and Safety
- Secondary Outcome Measures
Name Time Method