Cyclobenzaprine in Muscle Cramps With Liver Cirrhosis

Phase 3

• Conditions: Liver Cirrhosis
• Interventions: Drug: Cyclobenzaprine; Drug: Calcium Carbonate

• Registration Number: NCT02642861
• Lead Sponsor: Tanta University

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.

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 Timeline

• Study First Submitted: 2015-12-25
• Study First Submitted QC: 2015-12-29
• Study First Posted: 2015-12-30
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-30
• Last Update Posted: 2018-01-03
• Study Start: 2018-10
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Liver cirrhosis and has frequent muscle cramps

Exclusion Criteria

• Allergy to cyclobenzaprine
• Encephalopathy.
• Receiving antidepressant drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cyclobenzaprine	Cyclobenzaprine	Cyclobenzaprine administration for 2 weeks
PLacebo	Calcium Carbonate	Calcium carbonate for 2 weeks

Primary Outcome Measures

Name	Time	Method
Number of muscle cramps	3 months	The number of muscle cramps

Trial Locations

Locations (1)

Tanta university - faculty of medicine; 🇪🇬 Tanta, Egypt