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临床试验/NCT02642874
NCT02642874Unknown3 期

Methocarbamol in Treatment of Muscle Cramps in Cirrhotic Patients

Tanta University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年4月1日最近更新:
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. Methocarbamol is a central muscle relaxant used to treat skeletal muscle spasms. The mechanism of action of methocarbamol is currently unknown, but may involve the inhibition of carbonic anhydrase. Methocarbamol has a high therapeutic index, i.e. a wide range of safe and effective dosages.

详细描述

Muscle cramps markedly affect the quality of life in cirrhotic patients with no highly effective drug. Abrams et al compared patients with cirrhosis with those with congestive heart failure and found a significantly higher prevalence of weekly or daily cramps with cirrhosis (22%) vs patients with congestive heart failure (5%). Interestingly, there was no difference in diuretic use or dosing between the 2 groups, supporting that factors other than diuretic-mediated effects explained the differences. Methocarbamol is a central muscle relaxant used to treat skeletal muscle spasms. The mechanism of action of methocarbamol is currently unknown, but may involve the inhibition of carbonic anhydrase. Methocarbamol has a high therapeutic index, i.e. a wide range of safe and effective dosages.

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

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Cirrhotic patients with frequent muscle cramps.

排除标准

  • Elderly patients.
  • Encephalopathy

研究组 & 干预措施

Methocarbamol

Experimental

Methocarbamol twice daily

干预措施: Methocarbamol (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

change in number of muscle cramps

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sherief Abd-Elsalam

Consultant liver and GIT diseases- Tanta university hospital

Tanta University

研究点 (1)

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