Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-29 @ 7:21 AM
Study NCT ID:
NCT01768468
Status:
COMPLETED
Last Update Posted:
2013-10-14
First Post:
2013-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-11', 'studyFirstSubmitDate': '2013-01-11', 'studyFirstSubmitQcDate': '2013-01-14', 'lastUpdatePostDateStruct': {'date': '2013-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in 100mm Pain VAS', 'timeFrame': 'baseline throgh week 8'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in 100mm pain VAS', 'timeFrame': '12 weeks'}, {'measure': 'Change rate from baseline in 100mm Pain VAS', 'timeFrame': '8 weeks, 12 weeks'}, {'measure': 'Change from baseline in WOMAC', 'timeFrame': '8 weeks, 12 weeks'}, {'measure': 'Change from baseline in EQ-5D', 'timeFrame': '8 weeks, 12 weeks'}, {'measure': 'Change in the patient self-assessed & investigator-assessed overall symptom score', 'timeFrame': '8 weeks, 12 weeks'}, {'measure': 'Consumption of rescue medication', 'timeFrame': '4 times'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['LAYLA', 'Non-inferiority', '100mm pain VAS'], 'conditions': ['Osteoarthritis of the Knee']}, 'referencesModule': {'references': [{'pmid': '26821189', 'type': 'DERIVED', 'citation': 'Ha CW, Park YB, Min BW, Han SB, Lee JH, Won YY, Park YS. Prospective, randomized, double-blinded, double-dummy and multicenter phase IV clinical study comparing the efficacy and safety of PG201 (Layla) and SKI306X in patients with osteoarthritis. J Ethnopharmacol. 2016 Apr 2;181:1-7. doi: 10.1016/j.jep.2016.01.029. Epub 2016 Jan 25.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet and Joins tablet in the treatment of osteoarthritis of the knee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients ≥40 and ≤ 80years of age\n* Radiographic evidence of grade 2 or 3 osteoarthritis based on the Kellgren \\& Lawrene radiographic entry criteria\n* Stable osteoarthritis during 3 months\n* Score of 100mm pain VAS ≤ 80mm at screening\n* Score of 100mm pain VAS ≥ 50mm at baseline\n* Written consent form voluntarily\n\nExclusion Criteria:\n\n* Disease of spine or other Lower limb joints that could affect to evaluate the efficacy\n* History of surgery or arthroscopy of the study joint within 6 months\n* Trauma of study joint within 12 months\n* Medication of constantly(more than 1 week) corticosteroid by oral within 3 months\n* Medication of intra-articular injection within 3 months\n* Diagnosed with psychical disorder, and taking medication\n* History of upper gastrointestinal ulceration within 6 months\n* History of upper gastrointestinal bleeding within 12 months\n* Serum creatinine, ALT, AST, total bilirubin over UNL X 2.0 at screening test\n* History of hypersensitivity to LAYLA, JOINS, or NSAIDs\n* Participation in another clinical trials within 4 weeks\n* Medication of constantly (more than 1 week) narcotic analgesics within 3 months\n* Not consent about using effectual contraception method during trial\n* Pregnant or lactating woman\n* Investigator's judgment"}, 'identificationModule': {'nctId': 'NCT01768468', 'briefTitle': 'To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'PMG Pharm Co., Ltd'}, 'officialTitle': 'Double Blinded, Randomized, Active Drug Comparative, Multi-center, Phase IV Clinical Study to Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients', 'orgStudyIdInfo': {'id': 'LAYLA-P4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LAYLA', 'description': 'Drug : LAYLA tablet/ bid', 'interventionNames': ['Drug: LAYLA tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'JOINS', 'description': 'Drug : JOINS tablet/ tid', 'interventionNames': ['Drug: JOINS tablet']}], 'interventions': [{'name': 'LAYLA tablet', 'type': 'DRUG', 'otherNames': ['LAYLA 405.4mg'], 'description': '1 tablet twice a day', 'armGroupLabels': ['LAYLA']}, {'name': 'JOINS tablet', 'type': 'DRUG', 'otherNames': ['JOINS 200mg'], 'description': '1 tablet at each time, 3 times a day', 'armGroupLabels': ['JOINS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyug University Dongsan Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hanyang University Guri Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'SMG-SNU Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Suwon', 'country': 'South Korea', 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'Ye Soo Park', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hanyang University'}, {'name': 'Chul Won Ha', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}, {'name': 'Ye Yeon Won', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University School of Medicine'}, {'name': 'Jae Hyup Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SMG-SNU Boramae Medical Center'}, {'name': 'Byung Woo Min', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Keimyug University Dongsan Medical Center'}, {'name': 'Seung Beom Han', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Anam Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PMG Pharm Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}