Cyclobenzaprine in Muscle Cramps With Liver Cirrhosis

December 30, 2017 updated by: Sherief Abd-Elsalam, Tanta University

Cyclobenzaprine Treatment for Muscle Cramps in Cirrhotic Patients

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Tanta, Egypt
        • Tanta university - faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Liver cirrhosis and has frequent muscle cramps

Exclusion Criteria:

  • Allergy to cyclobenzaprine
  • Encephalopathy.
  • Receiving antidepressant drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of muscle cramps
Time Frame: 3 months
The number of muscle cramps
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2018

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

December 25, 2015

First Submitted That Met QC Criteria

December 29, 2015

First Posted (Estimate)

December 30, 2015

Study Record Updates

Last Update Posted (Actual)

January 3, 2018

Last Update Submitted That Met QC Criteria

December 30, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Muscle cramps treatment

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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