Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-02 @ 5:35 PM
Study NCT ID:
NCT02064634
Status:
UNKNOWN
Last Update Posted:
2016-03-17
First Post:
2014-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Observational Study on Discontinuation of Medication of Shinbaro Capsule
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-15', 'studyFirstSubmitDate': '2014-02-12', 'studyFirstSubmitQcDate': '2014-02-14', 'lastUpdatePostDateStruct': {'date': '2016-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Discontinuation rate due to gastrointestinal adverse effects', 'timeFrame': 'up to 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Rate of medication discontinuation recorded as lack of efficacy', 'timeFrame': 'up to 12 weeks', 'description': 'Number of participants discontinued from medication due to lack of efficacy'}, {'measure': 'Rate of medication discontinuation', 'timeFrame': 'up to 12 weeks', 'description': 'Number of participants discontinued from medication'}, {'measure': 'Discontinuation rate due to adverse events', 'timeFrame': 'up to 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Shinbaro Capsule', 'Celecoxib', 'Osteoarthritis', 'GCSB-5', 'Discontinuation rate', 'Gastrointestinal adverse event', 'NSAIDs', 'OASIS'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This study investigates how gastrointestinal toxicity affects discontinuation of medication given to patients with osteoarthritis in routine clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with osteoarthritis being treated with anti-inflammatory analgesic drug at general hospitals and clinics in South Korea', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Minimum 20- year-old patients diagnosed with osteoarthritis\n* Within 2 weeks prior to participation, not taken anti-inflammatory analgesic drug such as the Shinbaro Capsule, Celecoxib Capsule and NSAIDs(non-steroidal anti-inflammatory drugs)\n* Written consent form voluntarity\n\nExclusion Criteria:\n\n* Diagnosed with disease that may affect measurement of efficacy clinically\n* Diagnosed with clinically significant phycological disorder, and taking medication\n* Participated in a clinical trial within 4 weeks\n* Pregnant or lactating woman\n* History of malignant disease within the previous 5 years\n* Patients who seem not to participate in the study at investigator's discretion"}, 'identificationModule': {'nctId': 'NCT02064634', 'briefTitle': 'A Prospective Observational Study on Discontinuation of Medication of Shinbaro Capsule', 'organization': {'class': 'INDUSTRY', 'fullName': 'GC Biopharma Corp'}, 'officialTitle': 'A Multicenter, Comparative, Open Label, Prospective Observational Study on Discontinuation of Medication Due to Gastrointestinal Adverse Effects for the Patients Being Treated for Osteoarthritis With Anti-inflammatory Analgesic Drug', 'orgStudyIdInfo': {'id': 'GCSB_OS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Shinbaro (only)'}, {'label': 'Celecoxib (only)'}, {'label': 'Shinbaro + NSAIDs'}, {'label': 'Shinbaro + Celecoxib'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'state': 'Sonpa-gu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seong-Il Bin, M.D., Ph.D', 'role': 'CONTACT', 'email': 'sibin@amc.seoul.kr', 'phone': '82-2-3010-3530'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Seong-Il Bin, M.D., Ph.D', 'role': 'CONTACT', 'email': 'sibin@amc.seoul.kr', 'phone': '82-2-3010-3530'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Green Cross Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}