Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT01271660
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
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
75 Years
Study:
NCT01271660
Study Brief:
Protocol Section:
NCT01271660