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Methocarbamol in Treatment of Muscle Cramps in Cirrhotic Patients

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ClinicalTrials.gov Identifier: NCT02642874
Recruitment Status : Unknown
Verified July 2018 by Sherief Abd-Elsalam, Tanta University.
Recruitment status was:  Recruiting
First Posted : December 30, 2015
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

Study Description
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Brief Summary:
Muscle cramps markedly affect the quality of life in cirrhotic patients with no highly effective drug. Methocarbamol is a central muscle relaxant used to treat skeletal muscle spasms. The mechanism of action of methocarbamol is currently unknown, but may involve the inhibition of carbonic anhydrase. Methocarbamol has a high therapeutic index, i.e. a wide range of safe and effective dosages.

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

Detailed Description:
Muscle cramps markedly affect the quality of life in cirrhotic patients with no highly effective drug. Abrams et al compared patients with cirrhosis with those with congestive heart failure and found a significantly higher prevalence of weekly or daily cramps with cirrhosis (22%) vs patients with congestive heart failure (5%). Interestingly, there was no difference in diuretic use or dosing between the 2 groups, supporting that factors other than diuretic-mediated effects explained the differences. Methocarbamol is a central muscle relaxant used to treat skeletal muscle spasms. The mechanism of action of methocarbamol is currently unknown, but may involve the inhibition of carbonic anhydrase. Methocarbamol has a high therapeutic index, i.e. a wide range of safe and effective dosages.
Study Design
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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: Methocarbamol in Treatment of Muscle Cramps in Cirrhotic Patients
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Cramps

Arms and Interventions
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Arm Intervention/treatment
Experimental: Methocarbamol
Methocarbamol twice daily
 Drug: Methocarbamol
Methocarbamol twice daily
Other Name: Flexpro
Placebo Comparator: placebo
Calcium carbonate twice daily
 Drug: Calcium Carbonate
Calcium carbonate twice daily
Other Name: Calcitron


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


Eligibility Criteria
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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:

  • Cirrhotic patients with frequent muscle cramps.

Exclusion Criteria:

  • Elderly patients.
  • Encephalopathy
Contacts and Locations
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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): NCT02642874


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 Recruiting
Tanta, Elgharbia, Egypt
Contact: Sherief Abdelsalam, lecturer    00201095159522    Sheriefabdelsalam@yahoo.com   
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
More Information
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Responsible Party: Sherief Abd-Elsalam, Consultant liver and GIT diseases- Tanta university hospital, Tanta University
ClinicalTrials.gov Identifier: NCT02642874    
Other Study ID Numbers: methocarbamol
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
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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Muscle Cramp
Liver Cirrhosis
Spasm
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
 Methocarbamol
Calcium Carbonate
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Muscle Relaxants, Central
Neuromuscular Agents
Peripheral Nervous System Agents