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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorSherief Abd-Elsalam

About this trial

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. \[3,4\]

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cirrhosis

Muscle cramps( ≥3 cramps per week )

Disqualifiers

• Allergy to orphenadrine

Renal impairment

Pregnant and lactating women

Peripheral vascular disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • orphenadrine

    Drug

    Orphenadrine in muscle cramps in cirrhotic patients

  • Placebo

    Drug

    calcium in muscle cramps in cirrhotic patients

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Orphenadrine(Norflex)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Frequency of muscle cramps

questionnaire

Time frame
3 months

Secondary outcomes

1

Quality of life of these patients

questionnaire

Time frame
3 months

Other outcomes

Sponsors and contacts

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Sherief Abd-Elsalam

Lead sponsor

Tanta University

Sponsor institution

Tanta University

Collaborator