Gabapentin in Treatment of Muscle Cramps in Patients With Liver Cirrhosis

December 30, 2017 updated by: Sherief Abd-Elsalam, Tanta University
  • 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Elgharbia
      • Tanta, Elgharbia, Egypt
        • Tanta university - faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • liver cirrhosis patients

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gabapentin
Gabapentin twice daily
Drug: Gabapentin
Gapapentin twice daily
Other Names:
  • Gaptin
Placebo Comparator: PLacebo
Calcium carbonate twice daily
Drug: Calcium Carbonate
calcium carbonate twice daily
Other Names:
  • Calcitron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of muscle cramps
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2018

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

December 24, 2015

First Submitted That Met QC Criteria

December 24, 2015

First Posted (Estimate)

December 30, 2015

Study Record Updates

Last Update Posted (Actual)

January 3, 2018

Last Update Submitted That Met QC Criteria

December 30, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sherief Abd-Elsalam

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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