A Randomised, Double-blind, Placebo-controlled, Three-way Cross-over Single Center Study to Characterize the Phenotype in Patients With Morton's Neuroma and to Explore the Effect of Local Administration of Xylocaine (Lidocaine)
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- The baseline phenotypic Quantitative sensory testing (QST) variables (e.g. heat, cold, touch and mechanical pain perception). Sensory tests will be performed to measure pain and skin sensitivity by use of different pressure (mN) and temperature ( C)
研究概览
简要总结
To characterize the phenotype in patients with Morton's neuroma and to explore the effect of local administration of Xylocaine (lidocaine)
详细描述
A randomised, double-blind, placebo-controlled, three-way cross-over single center study to characterize the phenotype in patients with Morton's Neuroma and to explore the effect of local administration of Xylocaine (lidocaine)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patients with a clinical diagnosis of Morton's neuroma with symptoms of at least 3 months duration in one foot (affected foot)
- •Visual analogue scale (VAS) pain-score of = 40 mm in the painful foot at daily activities during the previous week (visit 1)
排除标准
- •Allergy to lidocaine
- •Scars or other dermal conditions on the feet that may interfere with study procedures
研究组 & 干预措施
Xylocaine_1mg
1 injection of Xylocaine (1 mg/mL)
干预措施: Xylocaine (Drug)
Xylocaine_10mg
1 injection of Xylocaine (10 mg/mL)
干预措施: Xylocaine (Drug)
Placebo
1 injection of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The baseline phenotypic Quantitative sensory testing (QST) variables (e.g. heat, cold, touch and mechanical pain perception). Sensory tests will be performed to measure pain and skin sensitivity by use of different pressure (mN) and temperature ( C)
时间窗: Before and after drug injection at Day 28 (+/-18).
The effect of Xylocaine compared to placebo in QST variables. Sensory tests will be performed to measure pain and skin sensitivity by use of different pressure (mN) and temperature ( C)
时间窗: After drug injection at Day 28 (+/-18).
次要结局
- Frequency/severity of adverse events(Day 43 (+/-32))