Liver Cirrhosis Clinical Trial
Official title:
A Randomized, Double-blinded, Placebo-controlled Study Evaluating the Efficacy and Safety of 6-week Treatment of Pregabalin Against Frequent Muscle Cramp in Patients With Liver Cirrhosis
Verified date | March 2020 |
Source | Seoul National University Boramae Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Muscle cramp is defined as a paroxysmal, involuntary, and painful contraction of skeletal
muscle. Cirrhotic patients can encounter with muscle cramp frequently, which might be
associated with poor quality of life. Gabapentin can be prescribed for muscle cramp. However,
patients with liver cirrhosis have limited access to gabapentin which is metabolized
primarily in liver.
Pregabalin with a similar mechanism of action to gabapentin undergoes negligible metabolism
owing to its improved pharmacokinetic properties. Thus, pregabalin might be a promising
therapeutic option for patients with liver cirrhosis who are suffering from muscle cramp and
susceptible to drug-induced hepatotoxicity.
Therefore, the investigators hypothesize that pregabalin could effectively reduce painful
symptoms derived from muscle cramp. In the current study, the investigators are going to
evaluate the efficacy and safety of pregabalin by comparing outcomes between two groups
(treatment group vs. placebo group).
Status | Completed |
Enrollment | 60 |
Est. completion date | March 2018 |
Est. primary completion date | February 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul Metropolitan Government Boramae Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Boramae Hospital | Pfizer |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in the frequency of muscle cramps between run-in and treatment phases (/week) | The frequency is defined as muscle cramps per week. | after 4 weeks of standard dose treatment period | |
Secondary | Response rates , Mean change in the average cramp pain intensity , peripheral nerve excitability , the quality of life, quality of sleep , safety | Response rates : the proportion (%) of patients showing =50% reduction in the number of muscle cramps. Mean change in the average cramp pain intensity : a sum of the pain rating scale divided by a total number of muscle cramps. Peripheral nerve excitability as measured by nerve stimulation test. The quality of life as measured by mean change in the score of the SF-36. Quality of sleep as measured by mean change in the number of muscle cramps during sleep. Safety as measured by dose-reduction or discontinuation rates, treatment-emergent adverse events, and vital signs. |
after 4 weeks of standard dose treatment period or over a 6-week treatment period |
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