A Pilot Study of Hydroxychloroquine for the Treatment of Muscle Cramps in Patients With Cirrhosis
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- frequency and severity of muscle cramps in cirrhotic patients reporting the symptom, based on the modified muscle cramps questionnaire (mMCQ)
研究概览
简要总结
This is a pilot study to see if hydroxychloroquine (HCQ) if safe and effective to use with patients having cramps due to their cirrhotic liver disease.
详细描述
This project is proposed as a pilot study to gather preliminary data for a full-scale randomized trial to assess the efficacy and safety of hydroxychloroquine (HCQ) in the treatment of muscle cramps in patients with cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •previous diagnosis of cirrhosis
- •adult (>21 years)
- •able to complete a written questionnaire in English
- •stable and ambulatory
- •MELD score < 25, Platelet count >25,000
排除标准
- •people allergic to hydroxychloroquine, 4-aminoquinolone derivatives or any component of the formulation
- •previous diagnosis of retinal or visual field changes attributable to 4-aminoquinolone
- •previous diagnosis of porphyria
- •previous diagnosis of psoriasis
- •fulminant hepatic failure
- •pregnant women
研究组 & 干预措施
hydroxychloroquine
干预措施: Hydroxychloroquine (Drug)
结局指标
主要结局
frequency and severity of muscle cramps in cirrhotic patients reporting the symptom, based on the modified muscle cramps questionnaire (mMCQ)
时间窗: 1 month after completion of questionnaire
Patients will be given the mMCQ and SF-12 to complete. These instruments will be scored according to established algorithms. Data analysis will include descriptive statistics (frequency, duration and severity of muscle cramps) and correlation between overall quality of life and the mMCQ summary score.
次要结局
- safety and efficacy of HCQ for severe cramping using mMCQ, SF-12, and AE inventory.(28 days after first dose)