Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-03-01 @ 9:00 PM
Study NCT ID:
NCT06890533
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-24
First Post:
2025-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of YZJ-4729 Tartrate Injection for the Treatment of Pain After Abdominal 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 560}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-21', 'studyFirstSubmitDate': '2025-03-11', 'studyFirstSubmitQcDate': '2025-03-21', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the Sum of Pain Intensity Differences Over 24 Hours at rest', 'timeFrame': '24 hours', 'description': 'Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NRS), with higher numbers indicating a higher pain intensity, administered over 24 hours.'}], 'secondaryOutcomes': [{'measure': 'The Time to first using rescue analgesics', 'timeFrame': '24 hours'}, {'measure': 'The proportion of subjects using rescue analgesics', 'timeFrame': '24 hours'}, {'measure': 'The number of times for rescue analgesics using', 'timeFrame': '24 hours'}, {'measure': 'The cumulative dose used of rescue analgesics', 'timeFrame': '24 hours'}, {'measure': 'the resting Sum of Pain Intensity Differences Over 6、12、18、12-24 Hours', 'timeFrame': '24 hours'}, {'measure': 'the active Sum of Pain Intensity Differences Over 6、12、18、24、12-24 Hours', 'timeFrame': '24 hours'}, {'measure': 'Participant satisfaction scores for analgesia treatment', 'timeFrame': '24 hours', 'description': 'Participants recalled the postoperative analgesia effect and rated their satisfaction on a scale of 1 to 5, with 1 representing dissatisfied and 5 representing very satisfied.'}, {'measure': 'Investigator satisfaction scores for analgesia treatment', 'timeFrame': '24 hours', 'description': 'Postoperative analgesia was evaluated by investigators. The scale ranges from 1 to 5, with 1 being dissatisfied and 5 being very satisfied.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate the analgesic efficacy and safety of IV YZJ-4729 Tartrate Injection in patients with acute postoperative pain following abdominal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be able to understand the study purpose and cooperate with the study procedures of this trial, voluntarily provide written informed consent\n2. Body mass index (BMI) ≥18 kg/m2 and ≤28 kg/m2.\n3. ASA I - II\n4. Experiences a pain intensity rating of moderate to severe acute pain following abdominal surgery, with a pain intensity score of ≥4 on a Numeric Rating Scale (NRS) within 4 hours post-surgery\n\nExclusion Criteria:\n\n1. Allergy to opioids and other medications that may be used during the trial.\n2. Nervous system disorders (e.g. epilepsy)\n3. Psychiatric disorders (e.g. depression)\n4. History of difficult airways\n5. Random blood glucose ≥11.1 mmol/L\n6. Uncontrolled blood pressure \\[e.g., hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg)，or hypotension(systolic blood pressure \\<90 mmHg)\\]\n7. Abnormal pulse oxygen saturation (SpO2 \\<90 %)\n8. Abnormal liver function or renal function\n9. Used agents that could affect the analgesic response\n10. Used agents that could affect drug metabolism\n11. Has previously participated in another YZJ-4729 clinical study'}, 'identificationModule': {'nctId': 'NCT06890533', 'briefTitle': 'A Study of YZJ-4729 Tartrate Injection for the Treatment of Pain After Abdominal Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Haiyan Pharmaceutical Technology Co., Ltd.'}, 'officialTitle': 'A Phase Ⅲ, Randomized, Double-Blind, Placebo- and Active-controlled Study of YZJ-4729 Tartrate Injection for the Treatment of Moderate to Severe Pain After Abdominal Surgery', 'orgStudyIdInfo': {'id': 'YZJ-4729-3-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group 1', 'interventionNames': ['Drug: Experimental: YZJ-4729']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Group 2', 'interventionNames': ['Drug: Experimental: YZJ-4729']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator', 'interventionNames': ['Drug: Placebo Comparator: Saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator', 'interventionNames': ['Drug: Active Comparator: Morphine']}], 'interventions': [{'name': 'Experimental: YZJ-4729', 'type': 'DRUG', 'description': 'Loading dose + demand dose', 'armGroupLabels': ['Experimental Group 1', 'Experimental Group 2']}, {'name': 'Placebo Comparator: Saline', 'type': 'DRUG', 'description': 'Loading dose + demand dose', 'armGroupLabels': ['Placebo Comparator']}, {'name': 'Active Comparator: Morphine', 'type': 'DRUG', 'description': 'Loading dose + demand dose', 'armGroupLabels': ['Active Comparator']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cangzhou', 'country': 'China', 'facility': 'Cangzhou Central Hospital', 'geoPoint': {'lat': 38.31124, 'lon': 116.85334}}, {'city': 'Cangzhou', 'country': 'China', 'facility': "Cangzhou People's Hospital", 'geoPoint': {'lat': 38.31124, 'lon': 116.85334}}, {'city': 'Changde', 'country': 'China', 'facility': "Changde First People's Hospital", 'geoPoint': {'lat': 29.03205, 'lon': 111.69844}}, 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{'type': 'SPONSOR'}}}}