Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT06780267
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of HRS-2129 for Postoperative Analgesia in Orthopaedics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 195}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-01-13', 'studyFirstSubmitQcDate': '2025-01-13', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety：Incidence and severity of AE/SAE', 'timeFrame': 'from ICF signing date to day 12 since last dose(14 days)'}], 'secondaryOutcomes': [{'measure': 'the Sum of Pain Intensity Differences in Pain Score Over 6hour、12hour、16hour、24hour、48hour、12hour-24hour、24hour-48hour under static and moving condition', 'timeFrame': '48hours'}, {'measure': 'The response rate of NRS scores under static and moving condition at 24hour and 48hour after the first dose of medication', 'timeFrame': '48hours'}, {'measure': "Participant ' satisfaction score for analgesia treatment", 'timeFrame': '48hours'}, {'measure': 'Investigator satisfaction score for analgesia treatment', 'timeFrame': '48hours'}, {'measure': 'Time of first use of remedial analgesic medication', 'timeFrame': '48hours'}, {'measure': 'Cumulative use of remedial analgesics', 'timeFrame': '48hours'}, {'measure': 'Cmax', 'timeFrame': '5 days'}, {'measure': 'Tmax', 'timeFrame': '5 days'}, {'measure': 'AUC0-12h', 'timeFrame': '5 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain in Orthopaedics']}, 'descriptionModule': {'briefSummary': 'The study is being conducted to evaluate the safety, and efficacy of HRS-2129 for Postoperative analgesia in orthopaedics. To explore the reasonable dosage of HRS-2129 for Postoperative analgesia in orthopaedics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able and willing to provide a written informed consent\n2. Subjects requiring elective orthopedic surgery\n3. Conform to the ASA Physical Status Classification\n\nExclusion Criteria:\n\n1. Subjects with a history of severe allergies\n2. Subjects with nervous system disease\n3. Subjects with a history of mental illness\n4. Subjects with abnormal liver and renal function\n5. Subjects with poorly controlled hypertensive or hypotensive\n6. QTc：\\>450ms（male），\\>470ms（female）\n7. Subjects who screened positive for substance abuse\n8. History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)\n9. The investigators determined that other conditions were inappropriate for participation in this clinical trial'}, 'identificationModule': {'nctId': 'NCT06780267', 'briefTitle': 'Clinical Study of HRS-2129 for Postoperative Analgesia in Orthopaedics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shandong Suncadia Medicine Co., Ltd.'}, 'officialTitle': 'Clinical Study on Safety and Efficacy of HRS-2129 for Postoperative Analgesiain Orthopaedics', 'orgStudyIdInfo': {'id': 'HRS-2129-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group: low\\middle\\high-dose', 'description': 'HRS-2129； HRS-2129 placebo', 'interventionNames': ['Drug: HRS-2129', 'Drug: HRS-2129 placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group:placebo', 'description': 'HRS-2129 placebo', 'interventionNames': ['Drug: HRS-2129 placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment group: positive control', 'description': 'Tramadol Hydrochloride SR Tablets', 'interventionNames': ['Drug: Tramadol Hydrochloride SR Tablets']}], 'interventions': [{'name': 'HRS-2129', 'type': 'DRUG', 'description': 'HRS-2129', 'armGroupLabels': ['Treatment group: low\\middle\\high-dose']}, {'name': 'HRS-2129 placebo', 'type': 'DRUG', 'description': 'HRS-2129 placebo', 'armGroupLabels': ['Treatment group: low\\middle\\high-dose', 'Treatment group:placebo']}, {'name': 'Tramadol Hydrochloride SR Tablets', 'type': 'DRUG', 'description': 'Tramadol Hydrochloride SR Tablets', 'armGroupLabels': ['Treatment group: positive control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610072', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mengchang Yang', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Qian Lei', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Lei Tang', 'role': 'CONTACT', 'email': 'lei.tang.lt31@hengrui.com', 'phone': '+0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Suncadia Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}