Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients

NCT04509336 | Terminated

• 1 other identifier: 2020-87
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

• the difference in the number of muscle cramps between the orphenadrine and baclofen groups at the end of treatment

  Questionnaire

  12 weeks

Secondary Outcomes (1)

• The difference in severity of cramps between orphenadrine and baclofen groups at the end of treatment

  12 weeks

Study Arms (2)

orphenadrine group

EXPERIMENTAL

orphenadrine

Drug: Orphenadrine

Baclofen group

ACTIVE COMPARATOR

Baclofen

Drug: Baclofen

Interventions

Orphenadrine DRUG

100 mg twice daily

orphenadrine group

Baclofen DRUG

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

Baclofen group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years
• Cirrhotic patients complaining of frequent muscle cramps (\>3 per week) for at least a month

You may not qualify if:

• Patients with allergy to study drugs
• Renal impairment
• Peripheral vascular disease
• Peripheral neuropathy
• Glaucoma
• Prostatic enlargement
• Pregnancy and lactation
• Patients taking calcium channel blockers, and conjugated estrogens
• 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
• Patients with alcoholic cirrhosis

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Egypt

Location

MeSH Terms

Conditions

Fibrosis

Interventions

Orphenadrine; Baclofen

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids

Study Officials

• Assem Elfert

  Tanta University

  STUDY CHAIR

• Sherif Abd-Elsalam

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of clinical pharmacy, pharmacy practice department

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: August 12, 2020
• Study Start: August 20, 2020
• Primary Completion: December 1, 2020
• Study Completion: September 20, 2021
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)