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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2028-12-31

Brief Summary

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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. \[3,4\]

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Detailed Description

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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

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Liver Cirrhosis Muscle Cramps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Orphenadrine(Norflex)

50 patients will be treated with orphenadrine 100 mg twice daily for 1 month

Group Type EXPERIMENTAL

orphenadrine

Intervention Type DRUG

Orphenadrine in muscle cramps in cirrhotic patients

Placebo

50 patients will be given placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

calcium in muscle cramps in cirrhotic patients

Interventions

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orphenadrine

Orphenadrine in muscle cramps in cirrhotic patients

Intervention Type DRUG

Placebo

calcium in muscle cramps in cirrhotic patients

Intervention Type DRUG

Other Intervention Names

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Norflex calcium

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No