Phase III study of HP-3150
- Conditions
- Cancer pain
- Registration Number
- JPRN-jRCT2080223595
- Lead Sponsor
- Hisamitsu Pharmaceutical Co., Inc.
- Brief Summary
The study consisted of a 2-week to 4-week open-label dose-titration phase and a 4-week double-blind phase. In the double-blind phase, patients were randomized to the HP-3150 or placebo group. In the FAS, time to insufficient analgesic response was significantly longer with HP-3150 than with placebo (P=0.0016). The HR for insufficient response for HP-3150 vs placebo was 0.459 (95%CI, 0.275-0.768). The incidence of AEs was 60.8% (73/120) in the HP-3150 group and 60.2% (71/118) in the placebo group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 341
Patients confirmed to have various types of cancer who were informed about their disease.
- Patients with abnormalities at the planned application site.
- Patients with a serious hematologic disorder, hepatic dysfunction, renal dysfunction, hypertension, or heart failure.
- Patients who have undergone an operation or nerve block, etc. that may affect assessment of pain.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Efficacy
- Secondary Outcome Measures
Name Time Method safety<br>Safety