Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-01-03 @ 10:00 PM
Study NCT ID:
NCT06509958
Status:
TERMINATED
Last Update Posted:
2024-10-30
First Post:
2024-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase Ⅱ Study of Adductor Canal Block With HR18034 for Postsurgical Pain Management in TKA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': "Sponsor's R\\&D Strategy adjusted", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-28', 'studyFirstSubmitDate': '2024-07-15', 'studyFirstSubmitQcDate': '2024-07-15', 'lastUpdatePostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-72h of the NRS-A pain intensity scores.', 'timeFrame': '0 to 72 hours', 'description': 'AUC of NRS pain intensity scores at activity (NRS-A) through 72 hours after the beginning of study drug administration.'}], 'secondaryOutcomes': [{'measure': 'AUC of the NRS-A pain intensity scores.', 'timeFrame': '0-24, 0-48hours', 'description': 'AUC of NRS pain intensity scores at activity (NRS-A) for time periods 0-24, 0-48 hours.'}, {'measure': 'AUC of the NRS-R pain intensity scores.', 'timeFrame': '0-24, 0-48，0-72 hours'}, {'measure': 'AUC of NRS pain intensity scores at rest (NRS-R) for time periods 0-24, 0-48 ,0-72 hours.', 'timeFrame': '0-24, 0-48 ,0-72 hours.'}, {'measure': 'Pain intensity assessed using an 12-point NRS ranging.', 'timeFrame': 'Baseline till 72 hours after the beginning of study drug administration'}, {'measure': 'Proportion of subjects who used no rescue opioid analgesic.', 'timeFrame': '0-24, 24-48, 48-72, 0-72 hours'}, {'measure': 'Total rescue analgesic consumption.', 'timeFrame': '0-24, 24-48, 48-72, 0-72 hours'}, {'measure': 'Time to the first postoperative use of rescue opioid analgesics.', 'timeFrame': '0-72hours'}, {'measure': 'Quadriceps muscle strength score.', 'timeFrame': 'Baseline till 72 hours after the beginning of study drug administration'}, {'measure': 'Range of motion of the knee joint.', 'timeFrame': 'Baseline till 72 hours after the beginning of study drug administration'}, {'measure': "Subjects' satisfaction rating", 'timeFrame': '72 hours'}, {'measure': "Investigators' satisfaction rating", 'timeFrame': '72 hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain Management in Total Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'Phase Ⅱ, randomized, double-blind, comparator-controlled study to evaluate the efficacy, safety and pharmacokinetics of single injection adductor canal block with HR18034 for postoperative pain management in total knee arthroplasty compared with ropivacaine.'}, '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. Scheduled to undergo primary unilateral total knee arthroplasty under general anesthesia.\n3. Male or female，aged ≥ 18 years\n4. Body mass index (BMI) ≥ 18 kg/m2\n5. American Society of Anesthesiologists (ASA) Physical Status Classification Ⅰ\\~Ⅲ\n\nExclusion Criteria:\n\n1. Subjects with deformity of the involving operative limb, or other neuropathy\n2. Subjects with a history of new myocardial infarction or unstable angina within 6 months prior to randomization;\n3. Subjects with a history of ischemic stroke or transient ischemic attack (TIA)\n4. Subjects with a history of mental system diseases and cognitive dysfunction\n5. Combination of other pain conditions that may affect postoperative pain assessment\n6. Persistent or recurrent nausea and/or vomiting due to other etiologies, including, but not limited to gastric outlet obstruction, hypercalcemia, or active peptic ulcer\n7. Subjects with a history of deep vein thrombosis-related disease\n8. Clinically significant abnormal clinical laboratory test value\n9. Allergic to a drug ingredient or component\n10. Use of any of medications, which affect drug metabolism or analgesia evaluation, within 5 half-lives or as specified prior to the study surgical procedure\n11. History of alcohol abuse or prescription and/or illicit drug abuse\n12. Pregnant or nursing women\n13. No birth control during the specified period of time\n14. Participated in clinical trials of other drugs (received experimental drugs)\n15. The inestigators determined that other conditions were inappropriate for participation in this clinical trial'}, 'identificationModule': {'nctId': 'NCT06509958', 'briefTitle': 'Phase Ⅱ Study of Adductor Canal Block With HR18034 for Postsurgical Pain Management in TKA', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Hengrui Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase Ⅱ Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Single Injection Adductor Canal Block With HR18034 for Postoperative Pain Management in Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'HR18034-204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose 1', 'interventionNames': ['Drug: HR18034']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 2', 'interventionNames': ['Drug: HR18034']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ropivacaine Hydrochloride Injection', 'interventionNames': ['Drug: Ropivacaine Hydrochloride Injection']}], 'interventions': [{'name': 'HR18034', 'type': 'DRUG', 'description': 'HR18034', 'armGroupLabels': ['Dose 1', 'Dose 2']}, {'name': 'Ropivacaine Hydrochloride Injection', 'type': 'DRUG', 'description': 'Ropivacaine Hydrochloride Injection', 'armGroupLabels': ['Ropivacaine Hydrochloride Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300052', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Hengrui Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}