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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

Page last updated: August 23, 2015

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