Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04509336
• Other study ID #: 2020-87
• Status: Terminated
• Phase: N/A
• Start date: August 20, 2020
• Est. completion date: September 20, 2021

Study information

• Verified date: April 2022
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 20, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Muscle Cramp
• Spasm

Intervention

Drug:
• Orphenadrine
100 mg twice daily
• Baclofen
initial dose of 10 mg tablet once daily, dose will be gradually increased according to the patients responses

Locations

Country	Name	City	State
Egypt	Tanta University Hospitals	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the difference in the number of muscle cramps between the orphenadrine and baclofen groups at the end of treatment	Questionnaire	12 weeks
Secondary	The difference in severity of cramps between orphenadrine and baclofen groups at the end of treatment	Visual analogue scale (VAS)	12 weeks