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Cyclobenzaprine in Muscle Cramps With Liver Cirrhosis

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ClinicalTrials.gov Identifier: NCT02642861
Recruitment Status : Not yet recruiting
First Posted : December 30, 2015
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

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

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Drug: Cyclobenzaprine Drug: Calcium Carbonate Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cyclobenzaprine Treatment for Muscle Cramps in Cirrhotic Patients
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Active Comparator: Cyclobenzaprine
Cyclobenzaprine administration for 2 weeks
Drug: Cyclobenzaprine
cyclobenzaprine administration for 2 weeks
Other Name: cyclosed

Placebo Comparator: PLacebo
Calcium carbonate for 2 weeks
Drug: Calcium Carbonate
Calcium carbonate for 2 weeks
Other Name: Calcitron




Primary Outcome Measures :
  1. Number of muscle cramps [ Time Frame: 3 months ]
    The number of muscle cramps



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Liver cirrhosis and has frequent muscle cramps

Exclusion Criteria:

  • Allergy to cyclobenzaprine
  • Encephalopathy.
  • Receiving antidepressant drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642861


Contacts
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Contact: Sherief M. Abd-Elsalam, Consultant 00201095159522 sherif_tropical@yahoo.com

Locations
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Egypt
Tanta university - faculty of medicine
Tanta, Egypt
Sponsors and Collaborators
Tanta University
Investigators
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Principal Investigator: Sherief M. Abd-Elsalam, Consultant liver diseases dept.- Tanta university hospital
Study Director: Walaa A. Elkhalawany, Consultant liver diseases dept.- Tanta university hospital

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Responsible Party: Sherief Abd-Elsalam, Consultant liver and GIT diseases- Tanta university hospital, Tanta University
ClinicalTrials.gov Identifier: NCT02642861     History of Changes
Other Study ID Numbers: Muscle cramps treatment
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Muscle Cramp
Spasm
Pathologic Processes
Liver Diseases
Digestive System Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Calcium
Calcium, Dietary
Calcium Carbonate
Cyclobenzaprine
Amitriptyline
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Muscle Relaxants, Central
Neuromuscular Agents
Peripheral Nervous System Agents