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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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02423395
Enrollment
100
Registered
2015-04-22
Start date
2015-01-31
Completion date
2028-12-31
Last updated
2019-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis, Muscle Cramps

Brief 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.\[5\]

Interventions

Orphenadrine in muscle cramps in cirrhotic patients

DRUGPlacebo

calcium in muscle cramps in cirrhotic patients

Sponsors

Tanta University
CollaboratorOTHER
Sherief Abd-Elsalam
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frameDescription
Frequency of muscle cramps3 monthsquestionnaire

Secondary

MeasureTime frameDescription
Quality of life of these patients3 monthsquestionnaire

Countries

Egypt

Contacts

Primary ContactSherief M Abd-Elsalam, lecturer
Sherif_tropical@yahoo.com01000058842

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026