TK-FT Phase 2 Study (Efficacy and Safety Study)
Phase 2
- Conditions
- Breakthrough cancer pain
- Registration Number
- JPRN-jRCT2080220503
- Lead Sponsor
- TEIKOKU SEIYAKU CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
1)Patients who were diagnosed with cancer
2)Patients who are 20-74 years old at the time of informed consent
3)Patients who are managed with opioid maintenance therapy for persistent cancer pain
4)Patients who are managed with rescue opioid for breakthrough cancer pain
etc.
Exclusion Criteria
1)Patients with uncontrolled or rapidly increasing cancer pain
2)Patients with organic encephalopathies such as intracranial hypertension, consciousness disturbed, coma or brain tumour
3)Patients with history of convulsive seizure
4)Patients with asthma
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy and Safety
- Secondary Outcome Measures
Name Time Method