Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-01 @ 6:23 AM
Study NCT ID:
NCT05375305
Status:
COMPLETED
Last Update Posted:
2023-12-26
First Post:
2022-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', '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': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-22', 'studyFirstSubmitDate': '2022-05-11', 'studyFirstSubmitQcDate': '2022-05-11', 'lastUpdatePostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the Sum of Pain Intensity Differences in Pain Score Over 48 Hours in the rest state', 'timeFrame': '48-hours', 'description': 'Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 48 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (48 hours) to yield values on the 0-10 NPRS.'}], 'secondaryOutcomes': [{'measure': 'the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、 48 、12-24、24-48 Hours under static and moving condition', 'timeFrame': '48-hours'}, {'measure': 'Time of first use of remedial analgesic medication', 'timeFrame': '48-hours'}, {'measure': 'Cumulative use of remedial analgesics from 0h to 48h', 'timeFrame': '48-hours'}, {'measure': "Participant ' satisfaction score for analgesia treatment", 'timeFrame': '48-hours'}, {'measure': 'Investigator satisfaction score for analgesia treatment', 'timeFrame': '48-hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate the analgesic efficacy of IV SHR8554 compared with morphine and placebo in patients with acute postoperative pain following orthopedic surgery.'}, '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 general anesthesia orthopedic surgery\n3. Conform to the ASA Physical Status Classification\n\nExclusion Criteria:\n\n1. Subjects with a history of difficult airway\n2. Subjects with a history of reflux esophagitis\n3. Subjects with a history of mental illness\n4. Subjects with poor blood pressure control\n5. Transcutaneous oxygen saturation (SpO2) \\<90%\n6. Random blood glucose ≥11.1mmol/L\n7. Subjects with abnormal liver function\n8. allergies to opioids and other medications that may be used during the trial'}, 'identificationModule': {'nctId': 'NCT05375305', 'briefTitle': 'A Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Phase II/Ⅲ, Randomized, Double-Blind, Dose-explored, Active-controlled Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery', 'orgStudyIdInfo': {'id': 'SHR8554-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group A：SHR8554 Injection', 'interventionNames': ['Drug: SHR8554 Injection']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group B：SHR8554 Injection', 'interventionNames': ['Drug: SHR8554 Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment group C：Saline Solution', 'interventionNames': ['Drug: Saline Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment group D：Morphine', 'interventionNames': ['Drug: Morphine']}], 'interventions': [{'name': 'SHR8554 Injection', 'type': 'DRUG', 'description': 'SHR8554 Injection; high dose', 'armGroupLabels': ['Treatment group A：SHR8554 Injection']}, {'name': 'SHR8554 Injection', 'type': 'DRUG', 'description': 'SHR8554 Injection; low dose', 'armGroupLabels': ['Treatment group B：SHR8554 Injection']}, {'name': 'Saline Solution', 'type': 'DRUG', 'description': 'Saline Solution', 'armGroupLabels': ['Treatment group C：Saline Solution']}, {'name': 'Morphine', 'type': 'DRUG', 'description': 'Morphine', 'armGroupLabels': ['Treatment group D：Morphine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Jiaotong University School of Medicine,Renji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}