Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-03 @ 10:29 PM
Study NCT ID:
NCT03341832
Status:
COMPLETED
Last Update Posted:
2019-09-18
First Post:
2017-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of NVP-1203 in Patients With Acute Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-16', 'studyFirstSubmitDate': '2017-11-09', 'studyFirstSubmitQcDate': '2017-11-09', 'lastUpdatePostDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS Pain Intensity', 'timeFrame': '3, 7 days', 'description': 'Improvement in VAS compared to baseline'}], 'secondaryOutcomes': [{'measure': 'Finger to Floor Distance (FFD)', 'timeFrame': '3, 7 days', 'description': 'Improvement in FFD compared to baseline'}, {'measure': 'Oswestry Disability Index(ODI)', 'timeFrame': '3, 7 days', 'description': 'Improvement in ODI compared to baseline'}, {'measure': 'Investigator Global Assessment of Response to Therapy(IGART)', 'timeFrame': '7 days', 'description': 'Improvement in IGART compared to baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety NVP-1203 in patients with Acute low back pain', 'detailedDescription': 'This study is a randomized, double-blind, active- and placebo-controlled, parallel, phase II study to evaluate efficacy and safety of NVP-1203 in patients with Acute low back pain'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 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* 19 Years and older\n* A patient has symptom of acute low back pain\n\nExclusion Criteria:\n\n* Subjects who cannot prohibit anti-inflammatory drug or muscle relaxants during clinical trial\n* Inadequate subject for the clinical trial by the investigator's decision"}, 'identificationModule': {'nctId': 'NCT03341832', 'briefTitle': 'Efficacy and Safety of NVP-1203 in Patients With Acute Low Back Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'NVP Healthcare'}, 'officialTitle': 'A Randomized, Double-blind, Active- and Placebo-controlled, Parallel, Multicenter, Phase II an Exploratory Clinical Trial to Evaluate the Efficacy and Safety NVP-1203 in Patients With Acute Low Back Pain', 'orgStudyIdInfo': {'id': 'NVP-1203_P2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NVP-1203', 'description': 'NVP-1203 plus NVP-1203-R placebo for up to 7 days, oral dose', 'interventionNames': ['Drug: NVP-1203', 'Drug: NVP-1203-R placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NVP-1203-R', 'description': 'NVP-1203-R plus NVP-1203 placebo for up to 7 days, oral dose', 'interventionNames': ['Drug: NVP-1203-R', 'Drug: NVP-1203 placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'NVP-1203 placebo plus NVP-1203-R placebo for up to 7 days, oral dose', 'interventionNames': ['Drug: NVP-1203 placebo', 'Drug: NVP-1203-R placebo']}], 'interventions': [{'name': 'NVP-1203', 'type': 'DRUG', 'description': 'oral dose for 7 days', 'armGroupLabels': ['NVP-1203']}, {'name': 'NVP-1203-R', 'type': 'DRUG', 'description': 'oral dose for 7 days', 'armGroupLabels': ['NVP-1203-R']}, {'name': 'NVP-1203 placebo', 'type': 'DRUG', 'description': 'oral dose for 7 days', 'armGroupLabels': ['NVP-1203-R', 'Placebo']}, {'name': 'NVP-1203-R placebo', 'type': 'DRUG', 'description': 'oral dose for 7 days', 'armGroupLabels': ['NVP-1203', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16209', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Navipharm', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'Seong-Hwan Moon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Severance Hospital'}, {'name': 'Jin Hwan Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inje University'}, {'name': 'Tae Kyun Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wonkwang University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NVP Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}