Phase III study of HFT-290
Phase 3
Completed
- Conditions
- Cancer pain
- Registration Number
- JPRN-jRCT2080223661
- Lead Sponsor
- Hisamitsu Pharmaceutical Co., Inc.
- Brief Summary
HFT-290 was administered to 208 of 209 enrolled patients. In the FAS, the response rate (95% confidence interval) was 87.0 (81.7-91.3)%. The lower limit of the 95% confidence interval of the response rate was higher than the threshold response rate, indicating the efficacy of HFT-290. Following dose escalation to 4 mg, respiratory depression occurred in one patient; however, this was considered a mild adverse event.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 209
Inclusion Criteria
Patients confirmed to have various types of cancer who were informed about their disease.
Exclusion Criteria
- Patients with abnormalities at the planned application site.
- Patients with serious cardiac, hepatic, or renal dysfunction, serious respiratory disorders, serious respiratory depression.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method