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Gabapentin in Treatment of Muscle Cramps in Patients With Liver Cirrhosis

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ClinicalTrials.gov Identifier: NCT02642484
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:
  • Muscle cramps markedly affect the quality of life in cirrhotic patients with no highly effective drug.
  • Quinine was suggested for treatment of patients with muscle cramps in patients with liver cirrhosis. However, thrombocytopenia, cardiac arrhythmias and cinchonism are serious side effects.

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

Detailed Description:
• The aim of the study was to assess the efficacy and safety of Gabapentin in the treatment of muscle cramps in patients with liver cirrhosis.

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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: Gabapentin in Treatment of Muscle Cramps in Patients With Liver Cirrhosis
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Active Comparator: Gabapentin
Gabapentin twice daily
Drug: Gabapentin
Gapapentin twice daily
Other Name: Gaptin

Placebo Comparator: PLacebo
Calcium carbonate twice daily
Drug: Calcium Carbonate
calcium carbonate twice daily
Other Name: Calcitron




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


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • liver cirrhosis patients

Exclusion Criteria:

  • allergy to gapabentin.
  • pregnancy and lactation. Renal failure.

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): NCT02642484


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, Elgharbia, Egypt
Sponsors and Collaborators
Tanta University
Investigators
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Principal Investigator: Sherief M. Abd-Elsalam, Consultant Hepatology and gastroenterology dept.-Tanta
Principal Investigator: A. K. Singal, Professor Division of Gastroenterology and Hepatology, UAB, Birmingham, AL, USA
Study Director: Walaa A. Elkhalawany, Lecturer Hepatology and gastroenterology dept.-Tanta

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Responsible Party: Sherief Abd-Elsalam, Consultant liver and GIT diseases- Tanta university hospital, Tanta University
ClinicalTrials.gov Identifier: NCT02642484     History of Changes
Other Study ID Numbers: Sherief Abd-Elsalam
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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Muscle Cramp
Liver Cirrhosis
Spasm
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Calcium, Dietary
Gabapentin
Calcium Carbonate
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents