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

NCT02423395 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-06-07

No results posted yet for this study

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. \[3,4\]

Conditions

Interventions

DRUG

orphenadrine

Orphenadrine in muscle cramps in cirrhotic patients

DRUG

Placebo

calcium in muscle cramps in cirrhotic patients

Sponsors & Collaborators

  • Tanta University

    collaborator OTHER

  • Sherief Abd-Elsalam

    lead OTHER

Principal Investigators

  • Asem A Elfert, Professor · TUH

  • Samah Mosaad, Lecturer · TUH

  • Lobna Aboaly, Professor · TUH

  • Walaa ElKhalawany, Lecturer · TUH

  • Sherief Abd-Elsalam, Lecturer · TUH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Egypt

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02423395 on ClinicalTrials.gov