Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients

Comparison of the Efficacy and Safety of Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04509336

Enrollment

Registered

2020-08-12

Start date

2020-08-20

Completion date

2021-09-20

Last updated

2022-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis

Brief summary

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.

Interventions

DRUGOrphenadrine

100 mg twice daily

DRUGBaclofen

initial dose of 10 mg tablet once daily, dose will be gradually increased according to the patients responses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
the difference in the number of muscle cramps between the orphenadrine and baclofen groups at the end of treatment	12 weeks	Questionnaire

Secondary

Measure	Time frame	Description
The difference in severity of cramps between orphenadrine and baclofen groups at the end of treatment	12 weeks	Visual analogue scale (VAS)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026