Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-04-14 @ 3:32 PM
Study NCT ID:
NCT01806818
Status:
COMPLETED
Last Update Posted:
2013-08-23
First Post:
2013-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Efficacy and Safety Between Eperisone a BID and a TID Regimen in Acute Low Back Pain Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-22', 'studyFirstSubmitDate': '2013-03-06', 'studyFirstSubmitQcDate': '2013-03-06', 'lastUpdatePostDateStruct': {'date': '2013-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS improvement of pain at rest, on movement and at night', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'Change of Modified Schober test', 'timeFrame': '7 days'}, {'measure': 'Change of Lateral Body Bending test', 'timeFrame': '7 days'}, {'measure': 'Change of EuroQol by patients', 'timeFrame': '7 days'}, {'measure': 'Change of Oswestry Disability Index', 'timeFrame': '7 days'}, {'measure': 'Overall pain improvement by investigator', 'timeFrame': 'at last visit (D7+2)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'Multi-center Study to Compare Efficacy and Safety between Eperisone a BID and a TID Regimen in Acute Low Back Pain Patients during 7 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects who have ability to comprehend the contents of study and before participating in trial and have willingness to sign of informed consent in writing\n* 20≤ age ≤60\n* A patient has symptom of acute low back pain\n* 4≤ VAS\n\nExclusion Criteria:\n\n* Subjects who cannot prohibit anti-inflammatory drug, painkiller or muscle relaxants during clinical trial\n* Chronic rheumatoid arthritis patients\n* Patients having a medical history of hypersensitivity to Eperisone Hydrochloride\n* Subject having a hereditary problem such as galactose intolerance, Lapp lactase deficiency, or glucose galatose malabsorption\n* Participation in other studies before 60 days of first dosing\n* Female patients having positive pregnancy test, lactating women,planning pregnancy during clinical trial\n* Inadequate subject for the clinical trial by the investigator's decision"}, 'identificationModule': {'nctId': 'NCT01806818', 'briefTitle': 'Comparing Efficacy and Safety Between Eperisone a BID and a TID Regimen in Acute Low Back Pain Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanmi Pharmaceutical Company Limited'}, 'officialTitle': 'A Phase 2, Randomized, Double-blind, Parallel, Placebo-controlled, Multi-center Study to Compare Efficacy and Safety Between Eperisone a BID and a TID Regimen in Acute Low Back Pain Patients', 'orgStudyIdInfo': {'id': 'HM-EPAC-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eperisone 50mg BID', 'description': 'Administrate Eperisone 50mg tablet after the breakfast and dinner, and pacebo tablet after the lunch for 7 days', 'interventionNames': ['Drug: Epirisone 50mg or placebo TID']}, {'type': 'EXPERIMENTAL', 'label': 'Epirisone 50mg TID', 'interventionNames': ['Drug: Epirisone 50mg or placebo TID']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo comparator', 'interventionNames': ['Drug: Epirisone 50mg or placebo TID']}], 'interventions': [{'name': 'Epirisone 50mg or placebo TID', 'type': 'DRUG', 'description': '3 times a day after meals for 1 week', 'armGroupLabels': ['Eperisone 50mg BID', 'Epirisone 50mg TID', 'Placebo comparator']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anyang', 'country': 'South Korea', 'facility': 'Hallym University Sacred Heart Hospital', 'geoPoint': {'lat': 36.9577, 'lon': 127.1464}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'CHA Bundang Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Medical college of Yonsei University, Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hak-Sun Kim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gangnam Severance Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}