JPRN-jRCT2080223005已完成3 期
A Japanese, phase 3, open-label, 14-week study of DS-5565 in patients with pain associated with diabetic peripheral neuropathy (DPNP) with renal impairment or post-herpetic neuralgia (PHN) with renal impairment
DAIICHISANKYO Co.,Ltd.0 个研究点目标入组 35 人开始时间: 2015年11月6日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
研究概览
简要总结
DS-5565 was safe and well tolerated in subjects with DPNP or PHN when used for 14 weeks, including 2-weeks' titration period, at a fixed dose of 7.5 mg BID for subjects with moderate RI and at a fixed dose of 7.5 mg QD for subjects with severe RI. DS-5565 reduced pain from baseline to Week 14 in subjects with DPNP or PHN and with moderate or severe RI.
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 with DPNP and patients with PHN:
- •-Average daily pain score >= 4
- •-Creatinine clearance (using Cockcroft-Gault equation): 15-59 mL/min at screening
- •Patients with DPNP only:
- •-Type 1 or Type 2 diabetes mellitus
- •-Painful distal symmetric polyneuropathy
- •Patients with PHN only:
- •-Post-herpetic neuralgia defined as pain present for more than 3 months after herpes zoster skin rash
排除标准
- •For patients with DPNP only:
- •-HbA1c > 10.0%
- •-Uncontrolled blood glucose at screening at initiation of study treatment that may require changes in diabetes treatment (non-insulin drug therapy, exercise therapy, diet therapy) during the study
- •-Other severe pain at screening or initiation of study treatment, unrelated to diabetic peripheral neuropathy (DPN), that may confound the assessment of DPNP
- •-Neurologic disorders at screening or initiation of study treatment, unrelated to DPN, that may confound the assessment of DPNP
- •For patients with PHN only:
- •-Previous use of neurolytic block (eg, chemical neurolytic block using phenol or ethyl alcohol, radiofrequency thermocoagulation) or neurosurgical therapy for current PHN
- •-Other severe pain at screening or initiation of study treatment, unrelated to PHN, that may confound the assessment of PHN
- •-Neurologic disorders at screening or initiation of study treatment, unrelated to PHN, that may confound the assessment of PH
研究者
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