Cyclobenzaprine in Muscle Cramps With Liver Cirrhosis

NCT ID: NCT02642861

Last Updated: 2018-01-03

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-31

Study Completion Date

2019-12-31

Brief Summary

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\- Cyclobenzaprine, is a muscle relaxer medication used to relieve skeletal muscle spasms. It is one of the best-studied drug for this application.

Detailed Description

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Although a number of mechanisms for cramps in liver disease have been postulated and have been targeted by medical therapies, a clear picture of the causal events has not emerged. Several agents as vitamin E, human albumin, zinc, taurine, eperisone hydrochloride and branched-chain amino acids have shown some benefit in small uncontrolled studies, although large randomized controlled trials are lacking.

\- Cyclobenzaprine, is a muscle relaxer medication used to relieve skeletal muscle spasms. It is one of the best-studied drug for this application.

Conditions

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Liver Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cyclobenzaprine

Cyclobenzaprine administration for 2 weeks

Group Type ACTIVE_COMPARATOR

Cyclobenzaprine

Intervention Type DRUG

cyclobenzaprine administration for 2 weeks

PLacebo

Calcium carbonate for 2 weeks

Group Type PLACEBO_COMPARATOR

Calcium Carbonate

Intervention Type DRUG

Calcium carbonate for 2 weeks

Interventions

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Cyclobenzaprine

cyclobenzaprine administration for 2 weeks

Intervention Type DRUG

Calcium Carbonate

Calcium carbonate for 2 weeks

Intervention Type DRUG

Other Intervention Names

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cyclosed Calcitron

Eligibility Criteria

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Inclusion Criteria

* Liver cirrhosis and has frequent muscle cramps

Exclusion Criteria

* Allergy to cyclobenzaprine
* Encephalopathy.
* Receiving antidepressant drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

Consultant liver and GIT diseases- Tanta university hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sherief M. Abd-Elsalam, Consultant

Role: PRINCIPAL_INVESTIGATOR

liver diseases dept.- Tanta university hospital

Walaa A. Elkhalawany, Consultant

Role: STUDY_DIRECTOR

liver diseases dept.- Tanta university hospital

Locations

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Tanta university - faculty of medicine

Tanta, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Sherief M. Abd-Elsalam, Consultant

Role: CONTACT

00201095159522

Other Identifiers

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Muscle cramps treatment

Identifier Type: -

Identifier Source: org_study_id

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