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Cyclobenzaprine in Muscle Cramps With Liver Cirrhosis

Sponsor
Tanta University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02642861
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
14
Anticipated Duration (Months)
14.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

  • Cyclobenzaprine, is a muscle relaxer medication used to relieve skeletal muscle spasms. It is one of the best-studied drug for this application.
Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

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.

  • Cyclobenzaprine, is a muscle relaxer medication used to relieve skeletal muscle spasms. It is one of the best-studied drug for this application.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Cyclobenzaprine Treatment for Muscle Cramps in Cirrhotic Patients
Anticipated Study Start Date :
Oct 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Cyclobenzaprine

Cyclobenzaprine administration for 2 weeks

Drug: Cyclobenzaprine
cyclobenzaprine administration for 2 weeks
Other Names:
  • cyclosed

    		•
    Placebo Comparator: PLacebo

    Calcium carbonate for 2 weeks

    Drug: Calcium Carbonate
    Calcium carbonate for 2 weeks
    Other Names:
  • Calcitron

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of muscle cramps [3 months]

      The number of muscle cramps

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Liver cirrhosis and has frequent muscle cramps
    Exclusion Criteria:

    • Allergy to cyclobenzaprine

    • Encephalopathy.

    • Receiving antidepressant drugs

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tanta university - faculty of medicine Tanta Egypt

    Sponsors and Collaborators

    • Tanta University

    Investigators

    • Principal Investigator: Sherief M. Abd-Elsalam, Consultant, liver diseases dept.- Tanta university hospital
    • Study Director: Walaa A. Elkhalawany, Consultant, liver diseases dept.- Tanta university hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sherief Abd-Elsalam, Consultant liver and GIT diseases- Tanta university hospital, Tanta University
    ClinicalTrials.gov Identifier:
    NCT02642861
    Other Study ID Numbers:
    • Muscle cramps treatment
    First Posted:
    Dec 30, 2015
    Last Update Posted:
    Jan 3, 2018
    Last Verified:
    Dec 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Muscle Cramp
    Liver Cirrhosis
    Spasm
    Fibrosis
    Cyclobenzaprine
    Calcium Carbonate
    Calcium

    Study Results

    No Results Posted as of Jan 3, 2018