Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-01-04 @ 6:28 PM
Study NCT ID:
NCT05254366
Status:
UNKNOWN
Last Update Posted:
2022-02-24
First Post:
2022-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Non-interventional Study of Remazolam Methyl Benzene Sulfonic Acid for Injection in Real-world Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-23', 'studyFirstSubmitDate': '2022-01-28', 'studyFirstSubmitQcDate': '2022-02-23', 'lastUpdatePostDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'Within 3 days of receiving gastroscopy and colonoscopy', 'description': 'Use adverse event record form,Refer to version 5.0 of the NCI-CTCAE'}], 'secondaryOutcomes': [{'measure': 'Serious adverse events', 'timeFrame': 'Within 3 days of receiving gastroscopy and colonoscopy', 'description': 'Refer to SAE definition standards'}, {'measure': 'Adverse drug reactions', 'timeFrame': 'Within 3 days of receiving gastroscopy and colonoscopy', 'description': 'By evaluating the association of adverse events with drugs'}, {'measure': 'Injection pain questionnaire', 'timeFrame': 'Within 3 days of receiving gastroscopy and colonoscopy', 'description': 'By observing and asking'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastroscopic and Colonoscopic Sedation']}, 'descriptionModule': {'briefSummary': 'This is a non-interventional study of remazolam toluenesulfonate (rebenin ®) for injection in Chinese patients. A total of 2000 patients were enrolled in this study based on the preliminary safety assessment of rebenin ®, and all safety information was obtained'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients receiving remazolam toluenesulfonate for painless gastroscopy and colonoscopy', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Use rebenin ® for painless gastroscopic sedation and painless colonoscopic sedation\n2. Patients need to sign informed consent\n\nExclusion Criteria:\n\n1. Patients who are participating in or planning to participate in any interventional clinical trial\n2. The investigator considers that there are any other reasons for the patient's ineligibility for the study"}, 'identificationModule': {'nctId': 'NCT05254366', 'briefTitle': 'A Non-interventional Study of Remazolam Methyl Benzene Sulfonic Acid for Injection in Real-world Clinical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Domestic, Prospective, Non-interventional Study of Remazolam Methyl Benzene Sulfonic Acid for Injection in Real-world Clinical Practice', 'orgStudyIdInfo': {'id': 'ARMS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Painless gastroscopic sedation cohort', 'interventionNames': ['Drug: Remimazolam Tosilate for Injection']}, {'label': 'Cohort 2', 'description': 'Painless colonoscopy sedation cohort', 'interventionNames': ['Drug: Remimazolam Tosilate for Injection']}], 'interventions': [{'name': 'Remimazolam Tosilate for Injection', 'type': 'DRUG', 'description': 'Remimazolam Tosilate for Injection', 'armGroupLabels': ['Cohort 1', 'Cohort 2']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ren-jie Huang', 'role': 'CONTACT', 'email': 'renjie.huang@hengrui.com', 'phone': '15651355862'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}