Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-25 @ 4:47 PM
Study NCT ID:
NCT04852003
Status:
COMPLETED
Last Update Posted:
2022-02-10
First Post:
2021-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial of SHR0410 Injection for the Treatment of Pain After Endoscopic Surgery of the Lower Abdominal
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': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'SHR0410 injection compared with placebo and morphine'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 228}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-27', 'studyFirstSubmitDate': '2021-04-15', 'studyFirstSubmitQcDate': '2021-04-19', 'lastUpdatePostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The area under the curve of pain intensity over 24 hours', 'timeFrame': '24-hours', 'description': 'Pain intensity will be evaluated using an 11-point (0-10) numeric rating scale (NRS), with higher numbers indicating a higher pain intensity, administered over 24 hours.'}], 'secondaryOutcomes': [{'measure': 'Total consumption of remedial analgesics from 0h to 24h', 'timeFrame': '24-hours', 'description': 'Total consumption of IV morphine'}, {'measure': "Participant ' satisfaction score for analgesia treatment", 'timeFrame': '24-hours', 'description': 'Participants recalled the postoperative analgesia effect and rated their satisfaction on a scale of 0 to 10, with 0 representing dissatisfied and 10 representing very satisfied.'}, {'measure': 'Investigator satisfaction score for analgesia treatment', 'timeFrame': '24-hours', 'description': 'Postoperative analgesia was evaluated by investigators. The scale ranges from 0 to 10, with 0 being dissatisfied and 10 being very satisfied.'}, {'measure': 'Frequency and severity of adverse events', 'timeFrame': 'Day 4（or early termination on Day 3）', 'description': 'Assessed by monitoring of adverse events. Participants with adverse events found to be related to the study drug will be compared to those receiving placebo or active comparator.'}, {'measure': 'Safety as assessed by vital signs', 'timeFrame': 'Day 4（or early termination on Day 3）', 'description': 'Changes in vital signs such as body temperature, blood pressure, heart rate will be assessed at specified times.'}, {'measure': 'Safety as assessed by laboratory evaluations', 'timeFrame': 'Day 4（or early termination on Day 3）', 'description': 'Assessed by laboratory evaluations at specified times. Participants with clinically significant lab values will be compared to those receiving placebo or active comparator.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The study is being conducted to evaluate the efficacy and safety of SHR0410 injection for the treatment of pain after endoscopic surgery of the lower abdominal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', '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 endoscopic surgery of the lower abdominal\n3. Male or female\n4. Meet the body mass index standard\n5. 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 mental illness\n3. Subjects with a history of cognitive impairment epilepsy\n4. Subjects with a history of myocardial infarction or unstable angina pectoris\n5. Subjects with atrioventricular block or cardiac insufficiency\n6. Subjects with a history of ischemic stroke or transient ischemic attack\n7. Subjects with poor blood pressure control after medication\n8. Subject with a history of substance abuse and drug abuse\n9. Abnormal values in liver function\n10. Subjects with an oxygen saturation below 90% on room air\n11. Allergic to drugs that may be used during the study\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 investigators determined that other conditions were inappropriate for participation in this clinical trial'}, 'identificationModule': {'nctId': 'NCT04852003', 'briefTitle': 'A Trial of SHR0410 Injection for the Treatment of Pain After Endoscopic Surgery of the Lower Abdominal', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Phase Ⅲ, Randomized, Double-blind, Placebo- and Active-controlled Study of SHR0410 Injection for the Treatment of Pain After Endoscopic Surgery of the Lower Abdominal', 'orgStudyIdInfo': {'id': 'SHR0410-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR0410 Injection', 'interventionNames': ['Drug: SHR0410 Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo for SHR0410 Injection', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Morphine', 'interventionNames': ['Drug: Morphine']}], 'interventions': [{'name': 'SHR0410 Injection', 'type': 'DRUG', 'description': 'SHR0410 Injection', 'armGroupLabels': ['SHR0410 Injection']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for SHR0410 Injection', 'armGroupLabels': ['Placebo for SHR0410 Injection']}, {'name': 'Morphine', 'type': 'DRUG', 'description': 'Morphine', 'armGroupLabels': ['Morphine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}