JPRN-jRCT2080222691已完成3 期
An Asian, phase 3, multicenter, randomized, double-blind, placebo-controlled 14-week study of DS-5565 in patients with post-herpetic neuralgia followed by a 52-week open-label extension
DAIICHISANKYO Co.,Ltd.0 个研究点目标入组 765 人开始时间: 2014年12月11日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 765
研究概览
简要总结
In this study, DS-5565 was administered at doses of 15 mg QD, 10 mg BID, or 15 mg BID for 14 weeks, including the titration period, to evaluate the efficacy and safety of DS-5565 in Asian patients with PHN. The mean changes from baseline in ADPS at Week 14 were greater as the daily dose of DS-5565 was increased, and the differences versus placebo were statistically significant in all DS-5565 treatment group. DS-5565 at a dose of 15 mg BID or below is considered safe and well tolerated.
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
- •Post-herpetic neuralgia defined as pain present for more than 3 months after herpes zoster skin rash
- •- Average daily pain score >= 4
排除标准
- •- Previous use of neurolytic block (eg, chemical neurolytic block using phenol or ethyl alcohol, radiofrequency thermocoagulation) or neurosurgical therapy for current post-herpetic neuralgia
- •- Other severe pain at screening or randomization, unrelated to post-herpetic neuralgia, that may confound the assessment of post-herpetic neuralgia
- •- Neurologic disorders at screening or randomization, unrelated to post-herpetic neuralgia, that may confound the assessment of post-herpetic neuralgia
研究者
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