NCT02423395

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sherief Abd-Elsalam · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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. \[3,4\]

Detailed 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.\[5\]

Conditions

• Liver Cirrhosis
• Muscle Cramps

Interventions

Type	Name	Description
DRUG	orphenadrine	Orphenadrine in muscle cramps in cirrhotic patients
DRUG	Placebo	calcium in muscle cramps in cirrhotic patients

Timeline

• Start date: 2015-01-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2015-04-22
• Last updated: 2019-06-07

Locations

1 site across 1 country: Egypt