A Randomised Three Week Double-blind Crossover Study to Compare the Efficacy and Safety of CNV2197944 75 mg Tid Versus Placebo in the Treatment of Neuropathic Pain in Patients With Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Pain Intensity Numerical Rating Scale
研究概览
简要总结
To investigate the effect of repeat oral dosing of CNV2197944 75 mg tid on the pain experienced in diabetic peripheral neuropathy (DPN) as measured by changes in PI-NRS after three weeks of treatment compared to the baseline period.
详细描述
A 3 week randomised crossover study to investigate the effect of repeat oral dosing of CNV2197944 75 mg tid versus placebo for on the pain experienced in diabetic peripheral neuropathy (DPN). Each 3 week treatment period is seperated by a 2 week washout period. The primary outcome measure is the change from baseline in the PI-NRS after three weeks of treatment. Secondary outcome measures include pain responder rates, clinical and patient global impressions of pain, and the Neuropathic Pain Symptom Inventory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between 18 and 85 years of age inclusive, at the time of signing the informed consent
- •Diabetes Mellitus (Type I or II)with HbA1c <9%
- •Evidence of symmetrical bilateral pain in lower limbs with evidence of decreased sensation or impaired reflexes and a Michigan Neuropathy Screening -Instrument score of >3 on physical examination
- •Patients with diabetic peripheral neuropathy (DPN) with pain at screening present for more than 6 months. The maximum duration of DPN will be no longer than 5 years
排除标准
- •Patients having other severe pain, which may impair the self-assessment of the pain due to DPN
- •Patients who have received nerve blocks for neuropathic pain within 4 weeks -Patients on other concomitant medications used to relieve the pain of DPN
- •Patients with a documented failure to respond to a maximally tolerated dose regimen of gabapentin or pregabalin
研究组 & 干预措施
CNV2197944
CNV2197944 75mg tid 21 days
干预措施: CNV2197944 (Drug)
Placebo
Placebo 1 cap tid 21 days
干预措施: Placebo (Drug)
结局指标
主要结局
Pain Intensity Numerical Rating Scale
时间窗: 21 days
次要结局
- Neuropathic Pain Symptom Inventory(21 days)
- Pain Responder rates(21 days)