Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-05 @ 8:50 AM
Study NCT ID:
NCT02375633
Status:
COMPLETED
Last Update Posted:
2016-10-10
First Post:
2015-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 3 Study of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C040375', 'term': 'pelubiprofen'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'lastUpdateSubmitDate': '2016-10-07', 'studyFirstSubmitDate': '2015-02-24', 'studyFirstSubmitQcDate': '2015-02-27', 'lastUpdatePostDateStruct': {'date': '2016-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of 100 mm Pain VAS', 'timeFrame': '28 days'}]}, 'conditionsModule': {'conditions': ['Chronic Back Pain']}, 'descriptionModule': {'briefSummary': 'A Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* More than 12 weeks by the time the trial started , and low back pain that requires analgesia administration.\n* Class 1 or 2 back pain patients along Quebec Task Force Classification\n* Patients with pain at least 40mm test results at visit2\n* The voluntary or legal guardian 's written consent to participate in this clinical trial subjects\n\nExclusion Criteria:\n\n* Severe gastrointestinal disease, heart disease, high blood pressure patients\n* Patients with secondary causes are obvious\n* Within 24 weeks patient who has back surgery before clinical trial participation\n* Within 4 weeks patient who experienced psychotropic drugs, a narcotic analgesic dosage that may affect the pain sensation\n* Within 4 weeks patient who treated steroid drug by oral or injection\n* Within 2 weeks patient who treated MAO inhibition drugs\n* Patients with severe respiratory depression status"}, 'identificationModule': {'nctId': 'NCT02375633', 'briefTitle': 'Phase 3 Study of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewon Pharmaceutical Co., Ltd.'}, 'orgStudyIdInfo': {'id': 'DW-330SR2_301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DW-330SR2', 'description': 'DW-330SR(Pelubiprofen) 45mg twice a day', 'interventionNames': ['Drug: DW-330SR2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pelubiprofen', 'description': 'Active Comparator(Pelubiprofen) 30mg three times a day', 'interventionNames': ['Drug: Pelubiprofen']}], 'interventions': [{'name': 'DW-330SR2', 'type': 'DRUG', 'armGroupLabels': ['DW-330SR2']}, {'name': 'Pelubiprofen', 'type': 'DRUG', 'armGroupLabels': ['Pelubiprofen']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewon Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}