NCT02642484Unknown3 期
Gabapentin in Treatment of Muscle Cramps in Patients With Liver Cirrhosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of muscle cramps
研究概览
简要总结
- Muscle cramps markedly affect the quality of life in cirrhotic patients with no highly effective drug.
- Quinine was suggested for treatment of patients with muscle cramps in patients with liver cirrhosis. However, thrombocytopenia, cardiac arrhythmias and cinchonism are serious side effects.
详细描述
• The aim of the study was to assess the efficacy and safety of Gabapentin in the treatment of muscle cramps in patients with liver cirrhosis.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •liver cirrhosis patients
排除标准
- •allergy to gapabentin.
- •pregnancy and lactation. Renal failure.
研究组 & 干预措施
Gabapentin
Active Comparator
Gabapentin twice daily
干预措施: Gabapentin (Drug)
PLacebo
Placebo Comparator
Calcium carbonate twice daily
干预措施: Calcium Carbonate (Drug)
结局指标
主要结局
Number of muscle cramps
时间窗: 3 months
次要结局
未报告次要终点
研究者
Sherief Abd-Elsalam
Consultant liver and GIT diseases- Tanta university hospital
Tanta University
研究点 (1)
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