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临床试验/NCT02423395
NCT02423395招募中3 期

Randomized Study of Orphenadrine' in the Treatment of Muscle Cramps in Patients With Cirrhosis

Sherief Abd-Elsalam1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Frequency of muscle cramps

研究概览

简要总结

Muscle cramps are common in patients with liver disease and associated with significantly diminished quality of life. Patients with cirrhosis often experience muscle cramps with varied frequency and severity. The exact mechanisms by which they occur remain unclear, although a number of pathophysiological events unique to liver disease may contribute. Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism, and plasma volume/electrolytes (1) Orphenadrine is an anticholinergic drug with prominent central nervous system (CNS) and peripheral actions used to treat painful muscle spasms and other similar conditions. The combination of anticholinergic effects and CNS penetration make orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles, and headaches. [3,4]

详细描述

Muscle cramps are common in patients with liver disease and associated with significantly diminished quality of life. Patients with cirrhosis often experience muscle cramps with varied frequency and severity. The exact mechanisms by which they occur remain unclear, although a number of pathophysiological events unique to liver disease may contribute. Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism, and plasma volume/electrolytes [1].

Although a number of mechanisms for cramps in liver disease have been postulated and have been targeted by medical therapies, a clear picture of the causal events has not emerged. Several agents as vitamin E, human albumin, zinc, taurine, eperisone hydrochloride and branched-chain amino acids have shown some benefit in small uncontrolled studies, although large randomized controlled trials are lacking [2].

Orphenadrine is an anticholinergic drug with prominent central nervous system (CNS) and peripheral actions used to treat painful muscle spasms and other similar conditions. The combination of anticholinergic effects and CNS penetration make orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles, and headaches. [3,4] Orphenadrine is structurally related to diphenhydramine and carries relatively stronger anticholinergic and weaker sedative properties, It is mostly excreted through the kidneys.[5]

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

性别
All
接受健康志愿者

入选标准

  • Cirrhosis
  • Muscle cramps( ≥3 cramps per week )

排除标准

  • • Allergy to orphenadrine
  • Renal impairment
  • Pregnant and lactating women
  • Peripheral vascular disease
  • Peripheral neuropathy
  • Medications as calcium channel blockers, conjugated estrogens and naproxen. Glaucoma Prostatic enlargement

研究组 & 干预措施

Orphenadrine(Norflex)

Experimental

50 patients will be treated with orphenadrine 100 mg twice daily for 1 month

干预措施: orphenadrine (Drug)

Placebo

Placebo Comparator

50 patients will be given placebo

干预措施: Placebo (Drug)

结局指标

主要结局

Frequency of muscle cramps

时间窗: 3 months

questionnaire

次要结局

  • Quality of life of these patients(3 months)

研究者

发起方
Sherief Abd-Elsalam
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sherief Abd-Elsalam

Study director

Tanta University

研究点 (1)

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