DS-7113b phase III study
Phase 3
- Conditions
- Moderate to severe cancer pain
- Registration Number
- JPRN-jRCT2080222289
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Patients receiving non-opioid analgesics for cancer pain, who have not been receiving opioid analgesics
- Patients whose VAS is >= 35 mm and judged necessary to be treated with strong opioid analgesics
- Patients with an ECOG Performance Status (PS) is =<3, etc.
Exclusion Criteria
Patients with symptom(s)/finding(s) falling under the contraindications or relative contraindications stated in the package insert for oxycodone hydrochloride powder and morphine hydrochloride preparations, etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of VAS between pre-treatment and end of treatment
- Secondary Outcome Measures
Name Time Method Response rate at end of treatment (analgesia improvement rate), efficacy and safety
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie DS-7113b's analgesic effects compared to IR oxycodone in cancer pain?
How does DS-7113b's efficacy in pain intensity reduction compare to IR oxycodone in phase III trials for opioid-naive patients?
Which biomarkers correlate with improved analgesic response to DS-7113b in moderate to severe cancer pain populations?
What are the safety profiles and adverse event management strategies for DS-7113b versus IR oxycodone in opioid-naive individuals?
Are there other extended-release opioid formulations or non-opioid analgesics being evaluated for cancer pain alongside DS-7113b by Daiichi Sankyo?