Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients

April 27, 2022 updated by: Noha Mansour, Mansoura University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt
        • Tanta University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: orphenadrine group
orphenadrine
Drug: Orphenadrine
100 mg twice daily
Active Comparator: Baclofen group
Baclofen
Drug: Baclofen
initial dose of 10 mg tablet once daily, dose will be gradually increased according to the patients responses

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Chair: Assem Elfert, Faculty of Medicine, Tanta University
  • Principal Investigator: Sherif Abd-Elsalam, Faculty of Medicine, Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2020

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

September 20, 2021

Study Registration Dates

First Submitted

July 21, 2020

First Submitted That Met QC Criteria

August 10, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Actual)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 27, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-87

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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