A Randomized Placebo Controlled Study of Orphenadrine` in the Treatment of Muscle Cramps in Patients With Cirrhosis
Information source: Tanta University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Liver Cirrhosis; Muscle Cramps
Intervention: orphenadrine (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Sherief Abd-Elsalam Official(s) and/or principal investigator(s): Asem A Elfert, Professor, Principal Investigator, Affiliation: TUH Samah Mosaad, Lecturer, Study Chair, Affiliation: TUH Lobna Aboaly, Ass. Professor, Study Chair, Affiliation: TUH Walaa ElKhalawany, Lecturer, Study Chair, Affiliation: TUH Sherief Abd-Elsalam, Lecturer, Study Director, Affiliation: TUH
Overall contact: Sherief M Abd-Elsalam, lecturer, Phone: 01000058842, Ext: 002, Email: Sherif_tropical@yahoo.com
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]
Clinical Details
Official title: A Randomized Placebo Controlled Study of Orphenadrine` in the Treatment of Muscle Cramps in Patients With Cirrhosis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Frequency of muscle cramps
Secondary outcome: Quality of life of these patients
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]
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Sherief M Abd-Elsalam, lecturer, Phone: 01000058842, Ext: 002, Email: Sherif_tropical@yahoo.com
Tanta university hospital, Tanta, Egypt; Recruiting Sherief Abd-Elsalam, Phone: 00201000040794, Email: Sherif_tropical@yahoo.com
Additional Information
Starting date: January 2015
Last updated: April 21, 2015
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