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NCT Number: NCT02423395

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

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]

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

About this study

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]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • • 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

Treatment and study plan

orphenadrine

Drug

Orphenadrine in muscle cramps in cirrhotic patients

Other names: Norflex

Placebo

Drug

calcium in muscle cramps in cirrhotic patients

Other names: calcium

Primary outcomes

  1. Frequency of muscle cramps

    Time frame: 3 months

    questionnaire

Secondary outcomes

  1. Quality of life of these patients

    Time frame: 3 months

    questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Sherief M Abd-Elsalam, lecturer

CONTACT

[email protected]

01000058842 ext. 002

Sponsors and collaborators

Lead sponsor

Sherief Abd-Elsalam

Other

Collaborators

  • Tanta University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2028
Study completion
2028
First posted
Apr 22, 2015
Registry last updated
Jun 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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