Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-04-18 @ 11:10 AM
Study NCT ID:
NCT05509868
Status:
UNKNOWN
Last Update Posted:
2022-08-22
First Post:
2022-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of PBK_L1704 for the Treatment of Moderate to Severe Acute Pain After Bunionectomy in South Korea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 225}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-19', 'studyFirstSubmitDate': '2022-08-19', 'studyFirstSubmitQcDate': '2022-08-19', 'lastUpdatePostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SPID-48', 'timeFrame': '48 hours', 'description': 'Sum of Pain Intensity Differences (SPID) from baseline to 48 hours'}], 'secondaryOutcomes': [{'measure': 'Responder rate', 'timeFrame': '48 hours', 'description': 'A patient is a responder if their final time-weighted Sum of Pain Intensity Differences from baseline (SPID-48) corresponds to, or is greater than, a 30% improvement.'}, {'measure': 'Time to rescue pain medication use', 'timeFrame': '48 hours'}, {'measure': 'Proportion of rescue pain medication use', 'timeFrame': '48 hours'}, {'measure': 'Total rescue pain medication use', 'timeFrame': '48 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Pain']}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate the analgesic efficacy of PBK\\_L1704 compared with placebo in patients with moderate to severe acute pain after bunionectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled to undergo primary, unilateral, first metatarsal bunionectomy with osteotomy and internal fixation\n* Able to understand and comply with the study procedures and requirements, and able to provide written informed consent before any study procedure.\n\nExclusion Criteria:\n\n* Participated in another oliceridine clinical study.\n* Received any investigational drug, device or therapy within 35 days before surgery.\n* Clinically significant medical, surgical, postsurgical, psychiatric or substance abuse condition or history of such condition that could confound the interpretation of efficacy, safety or tolerability data in the study.\n* American Society of Anesthesiologists (ASA) Physical Status Classification System classification III or worse.'}, 'identificationModule': {'nctId': 'NCT05509868', 'briefTitle': 'Study of PBK_L1704 for the Treatment of Moderate to Severe Acute Pain After Bunionectomy in South Korea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pharmbio Korea Co., Ltd.'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of PBK_L1704 for the Treatment of Moderate to Severe Acute Pain After Bunionectomy in South Korea', 'orgStudyIdInfo': {'id': 'PBK_L1704_301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PBK_L1704 0.35mg', 'interventionNames': ['Drug: PBK_L1704 0.35mg']}, {'type': 'EXPERIMENTAL', 'label': 'PBK_L1704 0.5mg', 'interventionNames': ['Drug: PBK_L1704 0.5mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PBK_L1704 0.35mg', 'type': 'DRUG', 'description': 'The subject will receive PBK\\_L1704 0.35mg/ml by PCA', 'armGroupLabels': ['PBK_L1704 0.35mg']}, {'name': 'PBK_L1704 0.5mg', 'type': 'DRUG', 'description': 'The subject will receive PBK\\_L1704 0.5mg/ml by PCA', 'armGroupLabels': ['PBK_L1704 0.5mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The subject will receive placebo by PCA', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Lee', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul Asan medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Manager Clinical Trial team, Pharmbio Korea', 'role': 'CONTACT', 'email': 'cr@pharmbio.co.kr', 'phone': '+82-2-587-2551'}], 'overallOfficials': [{'name': 'Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pharmbio Korea Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}