Efficacy and Safety of Oral Ataciguat (HMR1766) 200 mg Administered Once Daily for 28 Days on Pain Reduction in Patients With Neuropathic Pain. A Randomized, Double-blind, Placebo-controlled, Cross-over Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Change in average daily pain intensity
研究概览
简要总结
The primary objective of this study is to assess the efficacy of ataciguat versus placebo in reducing pain intensity in patients with neuropathic pain.
The secondary objective is to assess the safety and tolerability of ataciguat versus placebo.
详细描述
This study consists of two consecutive 28 day treatment periods which are separated by a 2 week medication free period and a safety follow-up period of 2 weeks after the second treatment period.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic neuropathic pain due to diabetic polyneuropathy or a nerve lesion following surgery. The pain must be present for more than 3 months.
排除标准
- •Presence or history of cancer within the past five years
- •Patients with a history of HIV infection
- •Patients with active hepatitis B or C
- •Patients with any pain other than the neuropathic pain of greater or equal severity
- •Patients with a diabetes mellitus for less than 6 months
- •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
1
First period: Ataciguat - Second period: Placebo
干预措施: ataciguat (HMR1766) (Drug)
1
First period: Ataciguat - Second period: Placebo
干预措施: placebo (Drug)
2
First period: Placebo - Second period: Ataciguat
干预措施: ataciguat (HMR1766) (Drug)
2
First period: Placebo - Second period: Ataciguat
干预措施: placebo (Drug)
结局指标
主要结局
Change in average daily pain intensity
时间窗: after 28-days treatment
次要结局
- Responder rate(after 28-days treatment)
- Rescue medication intake(during 28-days treatment)
- Change in Neuropathic Pain Symptom Inventory (NPSI)(after 28-days treatment)