Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04509336
Other study ID # 2020-87
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT01884415 - Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis Phase 3
Recruiting NCT05014594 - Sodium-glucose Linked Transporter 2 (SGLT-2) Inhibitors in Recurrent Ascites: a Pilot RCT Phase 2
Not yet recruiting NCT03631147 - The Effect of Rifaximin on Portal Vein Thrombosis N/A
Completed NCT04939350 - Evaluation of the Vaccination Coverage of Cirrhotic Patients Followed in the General Hospitals in France in 2021
Completed NCT02528760 - To Determine the Role of Prokinetics in Feed Intolerance in Critically Ill Cirrhosis N/A
Recruiting NCT05484206 - Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434 Phase 1
Not yet recruiting NCT05538546 - Baveno VI Criteria in Dynamic Monitoring of High-risk Varices in Compensated Cirrhotic Patients
Not yet recruiting NCT04053231 - Hepatocarcinoma Recurrence on the Liver Study - Part2
Recruiting NCT02983968 - Use of the French Healthcare Insurance Database
Completed NCT02705534 - Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1 Phase 3
Completed NCT02596880 - Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics Phase 3
Completed NCT02247414 - Warfarin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy and Azygoportal Disconnection Phase 4
Withdrawn NCT01956864 - Study of High-Dose Oral Vitamin D for the Prevention of Liver Cancer Phase 1
Completed NCT02016196 - Rifaximin vs Placebo for the Prevention of Encephalopathy in Patients Treated by TIPS Phase 3
Completed NCT01362855 - Advance Care Planning Evaluation in Hospitalized Elderly Patients
Completed NCT02113631 - Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir N/A
Completed NCT01447537 - Mechanisms Involved in the Benefits of an Exercise Programme in Patients With Cirrhosis N/A
Active, not recruiting NCT01205074 - ¹³C-Methacetin Breath Test (MBT) Methodology Study Phase 2/Phase 3
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT01231828 - Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies. N/A