A Study Evaluating the Efficacy and Safety of Pregabalin Against Frequent Muscle Cramp in Patients With Liver Cirrhosis
NCT01271660
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Adult Trials: 18+ Years
(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
- 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
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Study Evaluating the Efficacy and Safety of Pregabalin Against Frequent Muscle Cramp in Patients With Liver Cirrhosis | |||
| Official Title ICMJE | 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 | |||
| Brief Summary | 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). | |||
| Detailed Description | The investigators are planning to recruit patients with liver cirrhosis and muscle cramp, and collect the baseline clinical and laboratory data during the 4-week run-in period for each subject. After a run-in period, there will be the second step of patient selection to achieve a more homogenous study population. Then, patients will be randomly allocated into the treatment (pregabalin) and placebo (dummy) arms, by a web-based randomization program. After a treatment period (75 mg twice daily during the first 1 week as titration, 150 mg twice daily for 4 weeks as standard dose), the investigators will gather further study information of a standard dose period (150mg twice daily for 4 weeks) from the target population and the study subjects will enter the 1-week tapering period (75mg twice a day) to discontinuation. The primary outcome will be the difference in the frequency of muscle cramps between the run-in and treatment phases. The investigators also intend to assess the response rate, defined as the proportion (%) of patients showing ?50% reduction in the number of muscle cramps, mean change in the average pain intensity, mean change in the score of the Short Form 36 (SF-36, QualityMetric) health survey questionnaire, mean change in the frequency of muscle cramps during sleep, and mean change in the average cramp threshold frequency by the neurophysiologic study (nerve excitability test) and analyze the reasons for drop-out cases. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Care Provider) Primary Purpose: Treatment | |||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 60 | |||
| Original Estimated Enrollment ICMJE | 70 | |||
| Actual Study Completion Date ICMJE | March 2018 | |||
| Actual Primary Completion Date | February 2018 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria: (should follow all conditions described below)
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | up to 75 Years (Child, Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Korea, Republic of | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01271660 | |||
| Other Study ID Numbers ICMJE | 06-2010-132 IG-KOR-014-2010 ( Other Identifier: Pfizer reference number ) | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE |
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| Responsible Party | Won Kim, Seoul National University Boramae Hospital | |||
| Study Sponsor ICMJE | Seoul National University Boramae Hospital | |||
| Collaborators ICMJE | Pfizer | |||
| Investigators ICMJE |
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| PRS Account | Seoul National University Boramae Hospital | |||
| Verification Date | March 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||