DS-7113b phase III study
Phase 3
- Conditions
- Moderate to severe cancer pain
- Registration Number
- JPRN-jRCT2080222616
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Cancer pain patients meeting any of following
1) Patients on opioid analgesics (oral morphine, oral oxycodone, transdermal fentanyl, or tramadol) less than 240 mg in morphine equivalent and judged effective to be treated with strong opioid analgesics
2) Patients who have not been on opioid analgesics, whose VAS is 35 mm and over and judged necessary to be treated with strong opioid analgesics
3) Patients who prefer to take DS-7113b ER tablets after completion of the study treatment of DS7113-B-J303 trial
Exclusion Criteria
Patients with symptom(s)/finding(s) falling under the contraindications or relative contraindications stated in the package insert of oral oxycodone hydrochloride and morphine hydrochloride, etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy rate (post-switch improvement and analgesia improvement ) at each visit and early termination visit
- Secondary Outcome Measures
Name Time Method Pain Intensity (PI), efficacy and safety