NCT02957851已完成2 期
Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) for the Treatment of Peripheral Neuropathic Pain: A Randomises, International, Multicentre, Placebo-Controlled, Phenotype-stratified Phase IIa Study
Air Liquide Santé International22 个研究点 分布在 2 个国家目标入组 287 人开始时间: 2016年11月最近更新:
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
- 入组人数
- 287
- 试验地点
- 22
- 主要终点
- Pain intensity
研究概览
简要总结
To assess the effect of 3 consecutive days of one-hour administration of Nitrous Oxide/Oxygen 50%/50% (EMONO) versus placebo as Oxygen/Nitrogen 22%/78% (synthetic medical air), in add-on therapy to chronic analgesic treatments, on average pain intensity in patients with chronic peripheral neuropathic pain. A total of 250 randomised patients to be included in all the participating centres, i.e., 125 randomised patients in each of the 2 study groups treatments
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a mean pain intensity from 4 to 9 as assessed daily with a Numerating Rating Scale during the 7 day period preceding inclusion in spite of administration of usual pain treatments.
- •Neuropathic pain lasting for more than 3 months but less than 10 years
- •Definite or probable peripheral neuropathy
排除标准
- •legal incapacity
- •patient with another concomitant chronic pain
- •ongoing major depression
- •Chemotherapy-induced peripheral neuropathic pain
研究组 & 干预措施
Oxygen/Nitrogen (22%/78%)
Placebo Comparator
Medical Air
干预措施: Medical Air (Drug)
Nitrous Oxide/Oxygen (50%/50%)
Active Comparator
EMONO
干预措施: EMONO (Drug)
结局指标
主要结局
Pain intensity
时间窗: 7 days after the last administration of treatment
Numeric Rating Scale (NRS)
次要结局
- Pain intensity(28 days after the last administration of treatment)
- Pain characteristic(28 days after the last administration of treatment)
- Quality of life questionnaire(28 days after the last administration of treatment)
- Number of patients with adverse events(through study duration, up to 31 days)
研究者
研究点 (22)
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