Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-03-03 @ 2:07 PM
Study NCT ID:
NCT01271660
Status:
COMPLETED
Last Update Posted:
2020-03-20
First Post:
2011-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating the Efficacy and Safety of Pregabalin Against Frequent Muscle Cramp in Patients With Liver Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009120', 'term': 'Muscle Cramp'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-19', 'studyFirstSubmitDate': '2011-01-06', 'studyFirstSubmitQcDate': '2011-01-06', 'lastUpdatePostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in the frequency of muscle cramps between run-in and treatment phases (/week)', 'timeFrame': 'after 4 weeks of standard dose treatment period', 'description': 'The frequency is defined as muscle cramps per week.'}], 'secondaryOutcomes': [{'measure': 'Response rates , Mean change in the average cramp pain intensity , peripheral nerve excitability , the quality of life, quality of sleep , safety', 'timeFrame': 'after 4 weeks of standard dose treatment period or over a 6-week treatment period', 'description': 'Response rates : the proportion (%) of patients showing ≥50% reduction in the number of muscle cramps.\n\nMean change in the average cramp pain intensity : a sum of the pain rating scale divided by a total number of muscle cramps.\n\nPeripheral nerve excitability as measured by nerve stimulation test.\n\nThe quality of life as measured by mean change in the score of the SF-36.\n\nQuality of sleep as measured by mean change in the number of muscle cramps during sleep.\n\nSafety as measured by dose-reduction or discontinuation rates, treatment-emergent adverse events, and vital signs.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['muscle cramp', 'liver cirrhosis', 'pregabalin'], 'conditions': ['Muscle Cramp', 'Liver Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '35191232', 'type': 'DERIVED', 'citation': 'Ahn S, Hong YH, Lee DH, Joo SK, Jung YJ, Sohn SY, Choi K, Kim W. Efficacy and Safety of Pregabalin for Muscle Cramps in Liver Cirrhosis: A Double-Blind Randomized Controlled Trial. J Korean Med Sci. 2022 Feb 21;37(7):e56. doi: 10.3346/jkms.2022.37.e56.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPregabalin 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.\n\nTherefore, 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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: (should follow all conditions described below)\n\n* Etiology : Liver cirrhosis patients of any etiology, whether viral or non-viral\n* Occurrence of muscle cramp equal to or more than 2 times a week over the last month\n\nExclusion Criteria:\n\n* Preexisting disease : Occlusive vascular disease, thyroid disease, peripheral neuropathy\n* 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)\n* 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\n* 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\n* central nervous system (CNS) or peripheral nervous system (PNS) or muscular disease, stroke, cerebral palsy, multiple sclerosis, Parkinson disease, progressive muscular dystrophy, epilepsy\n* The previous episode of suicidal attack\n* Drug hypersensitivity\n* Subjects receiving antiepileptic drugs\n* Patients manipulating machines or driving cars\n* Pregnant women\n* Subjects with congestive heart failure requiring medications\n* Galactose-Lactose metabolic abnormality\n* Refractory ascites to medical treatment'}, 'identificationModule': {'nctId': 'NCT01271660', 'briefTitle': 'A Study Evaluating the Efficacy and Safety of Pregabalin Against Frequent Muscle Cramp in Patients With Liver Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Boramae Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '06-2010-132'}, 'secondaryIdInfos': [{'id': 'IG-KOR-014-2010', 'type': 'OTHER', 'domain': 'Pfizer reference number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pregabalin', 'description': '30 randomly allocated patients after a 4-week run-in period, who will take part in a 6-week treatment period with pregabalin.\n\nTreatment 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.', 'interventionNames': ['Drug: Pregabalin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '30 randomly allocated patients after a 4-week run-in period, who will take part in a 6-week treatment period with placebo.\n\nTreatment 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.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Pregabalin', 'type': 'DRUG', 'otherNames': ['Brand name of drug : Lyrica'], 'description': 'drug form : capsule, 75/150mg. Pregabalin will be provided to treatment arm subjects for 6-week Treatment period.\n\nTreatment period : 75 mg twice daily during the first 1 week as titration + 150mg twice daily for 4 weeks as maintenance + 75mg twice a day as tapering', 'armGroupLabels': ['Pregabalin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'drug form : capsule, 75/150mg. Pregabalin will be provided to treatment arm subjects for 6-week Treatment period.\n\nTreatment period : 75 mg twice daily during the first 1 week as titration + 150mg twice daily for 4 weeks as maintenance + 75mg twice a day as tapering', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '156-707', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Metropolitan Government Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Won Kim, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SMG-SNU Boramae Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Boramae Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Assistant Professor', 'investigatorFullName': 'Won Kim', 'investigatorAffiliation': 'Seoul National University Boramae Hospital'}}}}