Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients

Mansoura University

Status: Terminated

Conditions: Cirrhosis

Treatments: Drug: Baclofen; Drug: Orphenadrine

Study type: Interventional

Funder types: Other

Identifiers

NCT04509336

2020-87

Details and patient eligibility

About

Muscle cramps are commonly affects patients with cirrhosis. It adversely influences the quality of life of cirrhotic patients. Treatment of muscle cramps still challenging owing to the diversity of the responsible pathophysiological mechanisms.The effectiveness of baclofen and orphenadrine in controlling muscle cramps in cirrhotic patients has been presented in recent randomised controlled clinical trials;however, the comparative efficacy and safety between these two therapeutic options has not been previously investigated.

Enrollment: 5 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-70 years
2. Cirrhotic patients complaining of frequent muscle cramps (>3 per week) for at least a month

Exclusion criteria

1. Patients with allergy to study drugs
2. Renal impairment
3. Peripheral vascular disease
4. Peripheral neuropathy
5. Glaucoma
6. Prostatic enlargement
7. Pregnancy and lactation
8. Patients taking calcium channel blockers, and conjugated estrogens
9. Patients taking vitamin E, taurine, carnitine, narcotic pain medications, muscle relaxants, nonsteroidal anti-inflammatory drugs, or antispastic agents during and for 2 weeks following the study
10. Patients with alcoholic cirrhosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5 participants in 2 patient groups

orphenadrine group

Experimental group

Description:

orphenadrine

Treatment:

Drug: Orphenadrine

Baclofen group

Active Comparator group

Description:

Baclofen

Treatment:

Drug: Baclofen