JPRN-jRCT2080223595已完成3 期
Phase III study of HP-3150 in patients with cancer pain
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 341
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable(—)
- 性别
- All
入选标准
- •Patients confirmed to have various types of cancer who were informed about their disease.
排除标准
- •- 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.
研究者
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