Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-03-02 @ 8:02 PM
Study NCT ID:
NCT05459220
Status:
UNKNOWN
Last Update Posted:
2022-07-14
First Post:
2022-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of SHR0410 Injection for the Treatment of Pain After Laparoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 357}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-12', 'studyFirstSubmitDate': '2022-06-30', 'studyFirstSubmitQcDate': '2022-07-12', 'lastUpdatePostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Summed Pain Intensity Difference From 0-24 Hours (SPID0-24)', 'timeFrame': '0 to 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.'}], 'secondaryOutcomes': [{'measure': 'Summed Pain Intensity Difference Within The First 2 Hours、4 Hours、6 Hours、12 Hours、18 Hours (SPID2、SPID4、SPID6、 SPID12、SPID18)', 'timeFrame': '0 to 2 hours、0 to 4 hours、0 to 6 hours、0 to 12 hours、0 to 18 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.'}, {'measure': 'Estimated Time From The Start Of The Infusion Of Study Drug To The First NRS reaching 3 or less', 'timeFrame': '0 to 24 hours'}, {'measure': 'Total Pain Relief Within The First 2 Hours、4 Hours、6 Hours、12 Hours、18 Hours、24 Hours', 'timeFrame': '0 to 2 hours、0 to 4 hours、0 to 6 hours、0 to 12 hours、0 to 18 hours、0 to 24 hours', 'description': 'Patients reported their pain relief using a 5-point(0-4) categorical scale (PR), with "0" indicating "No Relief", "1" indicating "A Little Relief", "2" indicating "Some Relief ", "3" indicating "A Lot of Relief" and "4" indicating "Complete Relief".'}, {'measure': 'Total consumption of remedial analgesics from 0 to 24 hours', 'timeFrame': '24-hours'}, {'measure': "Participant' Satisfaction Score For Analgesia Treatment", 'timeFrame': '24-hours'}, {'measure': 'Investigator Satisfaction Score For Analgesia Treatment', 'timeFrame': '24-hours'}, {'measure': 'Numbers of Participants With Abnormal Vital Signs', 'timeFrame': 'Day 3 or Day 4', 'description': 'Changes in vital signs such as body temperature (using the celsius system) will be assessed at specified times.'}, {'measure': 'Numbers of Participants With Abnormal Vital Signs', 'timeFrame': 'Day 3 or Day 4', 'description': 'Changes in vital signs such as, blood pressure (using mmHg) will be assessed at specified times.'}, {'measure': 'Numbers of Participants With Abnormal Vital Signs', 'timeFrame': 'Day 3 or Day 4', 'description': 'Changes in vital signs such as , heart rate (measured by beats per minute) will be assessed at specified times.'}, {'measure': 'Numbers of Participants With Abnormal Laboratory Values', 'timeFrame': 'Day 3 or Day 4', 'description': 'Participants with clinically significant lab values will be compared to those receiving placebo comparator.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain Of Laparoscopic Surgery']}, 'descriptionModule': {'briefSummary': 'The study is being conducted to evaluate the efficacy and safety of SHR0410 injection for the treatment of pain after laparoscopic 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 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. Allergic to drugs that may be used during the study\n11. Pregnant or nursing women\n12. No birth control during the specified period of time\n13. Participated in clinical trials of other drugs (received experimental drugs)\n14. The investigators determined that other conditions were inappropriate for participation in this clinical trial'}, 'identificationModule': {'nctId': 'NCT05459220', 'briefTitle': 'A Trial of SHR0410 Injection for the Treatment of Pain After Laparoscopic Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Phase Ⅲ, Randomized, Double-blind, Placebo-controlled Study of SHR0410 Injection for the Treatment of Pain After Laparoscopic Surgery', 'orgStudyIdInfo': {'id': 'SHR0410-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group A', 'description': 'SHR0410 Injection（Low Dose）', 'interventionNames': ['Drug: SHR0410 Injection']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group B', 'description': 'SHR0410 Injection（High Dose）', 'interventionNames': ['Drug: SHR0410 Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment group C', 'description': 'Placebo for SHR0410 Injection.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SHR0410 Injection', 'type': 'DRUG', 'description': 'SHR0410 Injection（Low Dose）', 'armGroupLabels': ['Treatment group A']}, {'name': 'SHR0410 Injection', 'type': 'DRUG', 'description': 'SHR0410 Injection（High Dose）', 'armGroupLabels': ['Treatment group B']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for SHR0410 Injection.', 'armGroupLabels': ['Treatment group C']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Qin Liu', 'role': 'CONTACT', 'email': 'qin.liu@hengrui.com', 'phone': '+0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}