Gabapentin in Treatment of Muscle Cramps in Patients With Liver Cirrhosis

Tanta University

Status and phase: Unknown; Phase 3

Conditions: Liver Cirrhosis

Treatments: Drug: Gabapentin; Drug: Calcium Carbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT02642484

Sherief Abd-Elsalam

Details and patient eligibility

About

• 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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• liver cirrhosis patients

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups, including a placebo group

Gabapentin

Active Comparator group

Description:

Gabapentin twice daily

Treatment:

Drug: Gabapentin

PLacebo

Placebo Comparator group

Description:

Calcium carbonate twice daily

Treatment:

Drug: Calcium Carbonate