Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-24 @ 4:41 PM
Study NCT ID:
NCT03768466
Status:
COMPLETED
Last Update Posted:
2021-01-25
First Post:
2018-11-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Oxycodone/Naloxone (Targin®) in Persistent Moderate to Severe Low Back Pain Following NSAIDs Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2022-03-23', 'unreleaseDate': '2022-03-25'}, {'resetDate': '2022-08-19', 'releaseDate': '2022-03-31'}], 'estimatedResultsFirstSubmitDate': '2022-03-23'}}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-21', 'studyFirstSubmitDate': '2018-11-20', 'studyFirstSubmitQcDate': '2018-12-06', 'lastUpdatePostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of NRS average score from week 0 to week 8', 'timeFrame': 'week 8', 'description': 'reduction of pain intensity of week 8 average NRS score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of the study drug (Targin®) after 8 weeks of treatment in patients with moderate to severe low back pain who are uncontrolled\\* by NSAIDs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Korean patients age ≥ 19 years old\n2. Patients having moderate to severe low back pain (NRS pain score ≥4) for ≥ 7 days and ≤ 90 days not satisfactorily controlled with NSAIDs\n3. Patients showing average NRS pain score ≥4 over the last 1 week at screening point\n4. In case of previous opioids medication history, opioids wash-out period \\> 30 days before enrolment\n5. Patients who is willing to voluntarily sign informed consent\n\nExclusion Criteria:\n\n1. Patients with any history of hypersensitivity to oxycodone, naloxone or related products\n2. Low back pain coming from cancer, infectious disease, psychiatric issue or congenial cause\n3. Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT03768466', 'briefTitle': 'Efficacy and Safety of Oxycodone/Naloxone (Targin®) in Persistent Moderate to Severe Low Back Pain Following NSAIDs Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mundipharma Korea Ltd'}, 'officialTitle': 'An 8-week, Prospective, Interventional, Single-arm, Multi-centre, Phase IV Study to Evaluate the Efficacy and Safety of Controlled-release Oxycodone/Naloxone (Targin®) in Moderate to Severe Low Back Pain Patients Who Are Not Adequately Controlled by NSAIDs', 'orgStudyIdInfo': {'id': 'OXN18-KR-401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brand Name: Targin®', 'description': 'Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral', 'interventionNames': ['Drug: Brand Name: Targin®']}], 'interventions': [{'name': 'Brand Name: Targin®', 'type': 'DRUG', 'description': 'Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral', 'armGroupLabels': ['Brand Name: Targin®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07061', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'SMG-SNU Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'JaeHyup Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SMG-SNU Boramae Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mundipharma Korea Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-03-23', 'type': 'RELEASE'}, {'date': '2022-03-25', 'type': 'UNRELEASE'}, {'date': '2022-03-31', 'type': 'RELEASE'}, {'date': '2022-08-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mundipharma Korea Ltd'}}}}