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Recruiting Phase 3

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

NCT02423395 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 3
Started
2015-01
Last updated
2019-06-07

Condition(s) studied

Liver CirrhosisMuscle Cramps

Investigational drug(s) / intervention(s)

orphenadrinePlacebo

orphenadrine: Orphenadrine in muscle cramps in cirrhotic patients

Placebo: calcium in muscle cramps in cirrhotic patients

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

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Frequency of muscle cramps — 3 months
    questionnaire

Trial sites (1)

FacilityCityRegionStatus
Tanta university hospital Tanta Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02423395 on ClinicalTrials.gov ↗ ← All trials in Egypt