Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients

NCT ID: NCT04509336

Last Updated: 2022-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-20

Study Completion Date

2021-09-20

Brief Summary

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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

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Conditions

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Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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orphenadrine group

orphenadrine

Group Type EXPERIMENTAL

Orphenadrine

Intervention Type DRUG

100 mg twice daily

Baclofen group

Baclofen

Group Type ACTIVE_COMPARATOR

Baclofen

Intervention Type DRUG

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

Interventions

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Orphenadrine

100 mg twice daily

Intervention Type DRUG

Baclofen

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Noha Mansour

Lecturer of clinical pharmacy, pharmacy practice department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Assem Elfert

Role: STUDY_CHAIR

Tanta University

Sherif Abd-Elsalam

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

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Tanta University Hospitals

Tanta, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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2020-87

Identifier Type: -

Identifier Source: org_study_id

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