Gabapentin in Treatment of Muscle Cramps in Patients With Liver Cirrhosis

Phase 3

• Conditions: Liver Cirrhosis
• Interventions: Drug: Gabapentin; Drug: Calcium Carbonate

• Registration Number: NCT02642484
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-12-24
• Study First Submitted QC: 2015-12-24
• Study First Posted: 2015-12-30
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-30
• Last Update Posted: 2018-01-03
• Study Start: 2018-12
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• liver cirrhosis patients

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gabapentin	Gabapentin	Gabapentin twice daily
PLacebo	Calcium Carbonate	Calcium carbonate twice daily

Primary Outcome Measures

Name	Time	Method
Number of muscle cramps	3 months

Trial Locations

Locations (1)

Tanta university - faculty of medicine; 🇪🇬 Tanta, Elgharbia, Egypt