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临床试验/JPRN-jRCT2080223595
JPRN-jRCT2080223595已完成3 期

Phase III study of HP-3150 in patients with cancer pain

Hisamitsu Pharmaceutical Co., Inc.0 个研究点目标入组 341 人开始时间: 2017年7月20日最近更新:
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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