Cyclobenzaprine in Muscle Cramps With Liver Cirrhosis

Tanta University

Status and phase: Unknown; Phase 3

Conditions: Liver Cirrhosis

Treatments: Drug: Cyclobenzaprine; Drug: Calcium Carbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT02642861

Muscle cramps treatment

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Liver cirrhosis and has frequent muscle cramps

Exclusion criteria

• Allergy to cyclobenzaprine
• Encephalopathy.
• Receiving antidepressant drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups, including a placebo group

Cyclobenzaprine

Active Comparator group

Description:

Cyclobenzaprine administration for 2 weeks

Treatment:

Drug: Cyclobenzaprine

PLacebo

Placebo Comparator group

Description:

Calcium carbonate for 2 weeks

Treatment:

Drug: Calcium Carbonate