NCT01090622已完成1 期
Phase 2a, Double-blind, Placebo-controlled, 2-period, Crossover Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Oral Doses of XPF-001 in Patients With Inherited Erythromelalgia.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Pain intensity difference (PID) in each treatment period based on an 11-point Pain Intensity-NRS (where 0 = No pain and 10 = worst pain you can imagine)
研究概览
简要总结
The purpose of this study is to determine whether XPF-001 is safe and effective in the treatment of pain caused by Inherited Erythromelalgia (IEM).
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
- •The study requires you to:
- •Be18-75 years old
- •Have inherited erythromelalgia
- •Be experiencing pain caused by erythromelalgia (Moderate pain score 4/10)
- •Be generally healthy (apart from your pain)
- •Stop taking your usual pain medications for 9 days
- •Not be pregnant or breast-feeding
- •Your role in the study includes:
- •An out-patient screening visit
- •9-days/8 nights-in-patient treatment visit at Nijmegen Medical Center (where you will be closely monitored)
- •A follow up phone call (after your return home)
- •Taking the investigational medication daily
- •Recording your pain levels daily during stay at the Medical Center.
排除标准
- •Coexistent source of pain from other conditions
- •Receiving professional psychological support for dealing with IEM
- •Treatment for significant depression within 6 months of screening
- •Active HIV, Hepatitis B or C
- •Use of prescription or OTC medication between check-in and discharge
- •Women who are pregnant, or lactating
- •Not currently using adequate contraception
- •Alcoholism or alcohol or substance abuse
- •Presence or history of major psychiatric disturbance
- •Unwilling or unable to comply with all dietary and activity restrictions
- •Any other condition or finding that may pose undue risk for participation
- •Use of any other investigational drug in the 60 days prior to dosing
研究组 & 干预措施
Matching Placebo
Placebo Comparator
干预措施: Placebo (Drug)
XPF-001
Experimental
干预措施: XPF-001 (Drug)
结局指标
主要结局
Pain intensity difference (PID) in each treatment period based on an 11-point Pain Intensity-NRS (where 0 = No pain and 10 = worst pain you can imagine)
时间窗: 2 days
次要结局
未报告次要终点
研究者
研究点 (1)
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