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

Last updated: June 6, 2019
Sponsor: Sherief Abd-Elsalam
Overall Status: Active - Recruiting

Phase

3

Condition

Muscle Pain

Hepatic Fibrosis

Scar Tissue

Treatment

N/A

Clinical Study ID

NCT02423395
muscle cramps in cirrhotics
  • All Genders

Study Summary

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]

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Cirrhosis

  • Muscle cramps( ≥3 cramps per week )

Exclusion

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

Study Design

Total Participants: 100
Study Start date:
January 01, 2015
Estimated Completion Date:
December 31, 2028

Study Description

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]

Connect with a study center

  • Tanta university hospital

    Tanta,
    Egypt

    Active - Recruiting

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