RecruitingPhase 3NCT02423395

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

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


Sponsor

Sherief Abd-Elsalam

Enrollment

100 participants

Start Date

Jan 1, 2015

Study Type

INTERVENTIONAL

Conditions

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

Inclusion Criteria2

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

Exclusion Criteria6

  • • 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

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Interventions

DRUGorphenadrine

Orphenadrine in muscle cramps in cirrhotic patients

DRUGPlacebo

calcium in muscle cramps in cirrhotic patients


Locations(1)

Tanta university hospital

Tanta, Egypt

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NCT02423395


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