Comparison of the Efficacy and Safety of Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- the difference in the number of muscle cramps between the orphenadrine and baclofen groups at the end of treatment
研究概览
简要总结
Muscle cramps are commonly affects patients with cirrhosis. It adversely influences the quality of life of cirrhotic patients. Treatment of muscle cramps still challenging owing to the diversity of the responsible pathophysiological mechanisms.The effectiveness of baclofen and orphenadrine in controlling muscle cramps in cirrhotic patients has been presented in recent randomised controlled clinical trials;however, the comparative efficacy and safety between these two therapeutic options has not been previously investigated.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years
- •Cirrhotic patients complaining of frequent muscle cramps (>3 per week) for at least a month
排除标准
- •Patients with allergy to study drugs
- •Renal impairment
- •Peripheral vascular disease
- •Peripheral neuropathy
- •Prostatic enlargement
- •Pregnancy and lactation
- •Patients taking calcium channel blockers, and conjugated estrogens
- •Patients taking vitamin E, taurine, carnitine, narcotic pain medications, muscle relaxants, nonsteroidal anti-inflammatory drugs, or antispastic agents during and for 2 weeks following the study
- •Patients with alcoholic cirrhosis
研究组 & 干预措施
orphenadrine group
orphenadrine
干预措施: Orphenadrine (Drug)
Baclofen group
Baclofen
干预措施: Baclofen (Drug)
结局指标
主要结局
the difference in the number of muscle cramps between the orphenadrine and baclofen groups at the end of treatment
时间窗: 12 weeks
Questionnaire
次要结局
- The difference in severity of cramps between orphenadrine and baclofen groups at the end of treatment(12 weeks)
研究者
Noha Mansour
Lecturer of clinical pharmacy, pharmacy practice department
Mansoura University