JPRN-jRCT2031230412招募中2 期
A multicenter randomized, double-blind, placebo-controlled Phase 2 study to evaluate efficacy, safety, tolerability, pharmacokinetics and target engagement of GSK3858279 in adult participants with chronic Diabetic Peripheral Neuropathic Pain (DPNP) / NEPTUNE-17
Okawa Yasutoshi0 个研究点目标入组 240 人开始时间: 2023年10月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •Participant must be 18-75 years of age inclusive, at the time of signing the informed consent.
- •-Type I or Type II diabetes with painful, distal, symmetrical, sensory motor neuropathy attributed to diabetes, of at least 6 months duration.
- •-A pain score >-4 and less than or equal to (<-) 9 by the 11-point NRS (0-10) for average daily pain intensity over the past 24 hours at the screening visit.
- •-Body mass index (BMI) within the range 18-40 kilogram per meter square (kg/m^2)(inclusive)
- •-Capable of giving signed informed consent.
排除标准
- •-History or presence of cardiovascular, renal, gastrointestinal, lymphatic disorders which in the opinion of the investigator would interfere with the study procedures and/or assessments.
- •-Participant has current painful peripheral neuropathy due to a cause other than diabetes (e.g. pernicious anemia, hypothyroidism, post-herpetic neuralgia).
- •-History of significant allergies to monoclonal antibodies.
- •-Current enrolment or past participation in a clinical study of an investigational medicinal product intervention within the last 30 days or 5 half-lives (whichever is longer) of signing consent.
- •-Participants who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits, inability to complete the eDiary daily etc.) and/or otherwise considered by the Investigator to be unlikely to complete the study.
研究者
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