Cyclobenzaprine in Muscle Cramps With Liver Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:

Cyclobenzaprine Treatment for Muscle Cramps in Cirrhotic Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02642861
• Other study ID #: Muscle cramps treatment
• Status: Not yet recruiting
• Phase: Phase 3
• First received: December 25, 2015
• Last updated: December 30, 2017
• Start date: October 2018
• Est. completion date: December 2019

Study information

• Verified date: December 2017
• Source: Tanta University
• Contact: Sherief M. Abd-Elsalam, Consultant
• Phone: 00201095159522
• Email: sherif_tropical[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Liver cirrhosis and has frequent muscle cramps

Exclusion Criteria:

• Allergy to cyclobenzaprine

• Encephalopathy.

• Receiving antidepressant drugs

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Muscle Cramp
• Spasm

Intervention

Drug:
• Cyclobenzaprine
cyclobenzaprine administration for 2 weeks
• Calcium Carbonate
Calcium carbonate for 2 weeks

Locations

Country	Name	City	State
Egypt	Tanta university - faculty of medicine	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of muscle cramps	The number of muscle cramps	3 months