DS-7113b injection phase II/III study (intravenous administration)
Phase 2
- Conditions
- Moderate to severe cancer pain
- Registration Number
- JPRN-jRCT2080222684
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1) Patients who can be hospitalized during a dosage period, and secure a route to carry out intravenous administration
2) Patients receiving analgesics for cancer pain
3) 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 oral oxycodone hydrochloride and morphine hydrochloride, etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate by Day 7 (analgesia improvement rate)
- Secondary Outcome Measures
Name Time Method Change of pain intensity (PI) and VAS, efficacy and safety