A Study Evaluating the Efficacy and Safety of Pregabalin Against Frequent Muscle Cramp in Patients With Liver Cirrhosis
Muscle Cramp, Liver Cirrhosis
About this trial
This is an interventional treatment trial for Muscle Cramp focused on measuring muscle cramp, liver cirrhosis, pregabalin
Eligibility Criteria
Inclusion Criteria: (should follow all conditions described below)
- Etiology : Liver cirrhosis patients of any etiology, whether viral or non-viral
- Occurrence of muscle cramp equal to or more than 2 times a week over the last month
Exclusion Criteria:
- Preexisting disease : Occlusive vascular disease, thyroid disease, peripheral neuropathy
- Drugs within 2 months : Digitalis, cimetidine, clofibrate, lithium, opiate, nifedipine, beta-agonist, beta-blocker, penicillamine, gabapentin, pregabalin, tricyclic anti-depressant, carbamazepine, phenytoin, quinidine, antispastic drugs, verapamil, vitamin E, branched chain amino acid, excessive alcohol consumption (male >40 g/day, female >20 g/day)
- Underlying disease : Renal impairment (Ccr < 60 mL/min), neuromuscular disease (stroke, cerebral palsy, multiple sclerosis, Parkinson disease, progressive muscular dystrophy, epilepsy), suicidal attack, drug allergy, pregnancy, heart failure
- Liver status : Serious complications resulting from decompensated cirrhosis except ascites, such as portosystemic encephalopathy, acute variceal bleeding within the past 3 months from study entry
- central nervous system (CNS) or peripheral nervous system (PNS) or muscular disease, stroke, cerebral palsy, multiple sclerosis, Parkinson disease, progressive muscular dystrophy, epilepsy
- The previous episode of suicidal attack
- Drug hypersensitivity
- Subjects receiving antiepileptic drugs
- Patients manipulating machines or driving cars
- Pregnant women
- Subjects with congestive heart failure requiring medications
- Galactose-Lactose metabolic abnormality
- Refractory ascites to medical treatment
Sites / Locations
- Seoul Metropolitan Government Boramae Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Pregabalin
Placebo
30 randomly allocated patients after a 4-week run-in period, who will take part in a 6-week treatment period with pregabalin. Treatment period : 75 mg twice daily during the first 1 week as titration + 150mg twice daily for 4 weeks as standard dose period + 75mg twice a day for a week as tapering period.
30 randomly allocated patients after a 4-week run-in period, who will take part in a 6-week treatment period with placebo. Treatment period : 75 mg twice daily during the first 1 week as titration + 150mg twice daily for 4 weeks as standard dose period + 75mg twice a day for a week as tapering period.