NCT00502515已完成2 期
A Multi-center, Randomized, Double-blind, Placebo Controlled Study of the Effect of SSR180575 at Two Doses for 24 Weeks Treatment on the Rate of Regeneration of Epidermal Nerve Fibers in Patients With Mild Diabetic Peripheral Neuropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 309
- 试验地点
- 1
- 主要终点
- Rate of epidermal nerve fiber regeneration
研究概览
简要总结
The primary objective of this sudy is to assess the effect of two doses of SSR180575 on the rate of regeneration of epidermal nerve fibers following denervation of the epidermal layer with capsaicin in patients with diabetes mellitus and mild peripheral neuropathy. Secondary objectives are to explore the efficacy of SSR180575 on clinical assessment, nerve function measures and to assess the tolerability and safety of SSR180575. The treatment period is 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Diabetes Mellitus, type I or II, treated or untreated
- •Diabetic neuropathy treated or untreated
排除标准
- •Patients with unstable glycemic control
- •Patients who have been hospitalized for a diabetes complication in the 3 months prior to randomization
- •Patients with peripheral neuropathy attributable to any cause other than diabetes
- •Non-measurable sural nerve sensory response on nerve conduction studies
- •Amputation of any part of lower extremity
- •Patients with a history of myocardial infarction or known coronary artery disease
- •Grade III or IV heart failure on New York Heart Association criteria
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
25 mg SSR180575
Experimental
orally once daily for 24 weeks
干预措施: SSR180575 (Drug)
100 mg SSR180575
Experimental
orally once daily for 24 weeks
干预措施: SSR180575 (Drug)
Placebo
Placebo Comparator
orally once daily for 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of epidermal nerve fiber regeneration
时间窗: 24 weeks
次要结局
- Efficacy: change between baseline and 24 weeks of peripheral neuropathy assessed with nerve conduction studies, clinical evaluation, Total Neuropathy Score(24 weeks)
- Safety: physical examination, clinical laboratories, adverse event reporting(24 weeks)
研究者
研究点 (1)
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