Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients

Not Applicable

Terminated

• Conditions: Cirrhosis
• Interventions: Drug: Orphenadrine; Drug: Baclofen

• Registration Number: NCT04509336
• Lead Sponsor: Mansoura University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-12
• Study Start: 2020-08-20
• Primary Completion: 2020-12-01
• Study Completion: 2021-09-20
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-27
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
orphenadrine group	Orphenadrine	orphenadrine
Baclofen group	Baclofen	Baclofen

Primary Outcome Measures

Name	Time	Method
the difference in the number of muscle cramps between the orphenadrine and baclofen groups at the end of treatment	12 weeks	Questionnaire

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, Egypt