Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2025-12-27 @ 10:35 PM
Study NCT ID:
NCT06169995
Status:
COMPLETED
Last Update Posted:
2023-12-29
First Post:
2023-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Remimazolam Tosilate for Sedation in the Upper Gastrointestinal Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-25', 'studyFirstSubmitDate': '2023-12-06', 'studyFirstSubmitQcDate': '2023-12-06', 'lastUpdatePostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage(%) of paticipants who experienced successful sedation in Upper Gastrointestinal Endoscopy', 'timeFrame': 'on Day1'}], 'secondaryOutcomes': [{'measure': 'Percentage of subjects receiving supplemental dose for sedation', 'timeFrame': 'on Day1'}, {'measure': 'The number of supplemental doses of the research drug', 'timeFrame': 'on Day1'}, {'measure': 'Wake-up time.', 'timeFrame': 'on Day1'}, {'measure': 'Incidence of sedation hypotension.', 'timeFrame': 'on Day1'}, {'measure': 'Incidence of respiratory depression', 'timeFrame': 'on Day1'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sedation in the Upper Gastrointestinal Endoscopy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in Upper Gastrointestinal Endoscopy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients or their guardians are able to provide a written informed consent\n2. participants undergo upper gastrointestinal endoscopy\n3. ≥18 years old, male or female\n4. 18 kg/m2≤bmi≤30kg/m2\n\nExclusion Criteria:\n\n1. Subjects to be intubated (including laryngeal mask placement);\n2. Complex endoscopic diagnosis and treatment operations are required;\n3. Severe cardiovascular disease within 6 months prior to signing the ICF;\n4. Heart rate \\< 50 beats/min during screening period;\n5. Subjects with poor blood pressure control during screening;\n6. Severe arrhythmias or heart disease; the circulatory system is unstable;\n7. Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness\n8. Subjects with a history of drug abuse;\n9. Abnormal values of the laboratory examination;\n10. Allergic to relevant drugs ingredient or component;\n11. Pregnant or nursing women;\n12. Subjects who has participated in clinical trials of other interventions recently;\n13. Other conditions deemed unsuitable to be included.'}, 'identificationModule': {'nctId': 'NCT06169995', 'briefTitle': 'A Study of Remimazolam Tosilate for Sedation in the Upper Gastrointestinal Endoscopy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Multi-center, Open-label，Single-arm Clinical Trial to Evaluate the Efficacy and Safety of Remimazolam Tosilate for Injection for Sedation in Upper Gastrointestinal Endoscopy', 'orgStudyIdInfo': {'id': 'HR7056-402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remimazolam Tosilate for Injection', 'interventionNames': ['Drug: Remimazolam Tosilate']}], 'interventions': [{'name': 'Remimazolam Tosilate', 'type': 'DRUG', 'description': 'bolus dose: 5mg，IV supplemental dose: 2.5mg，IV', 'armGroupLabels': ['Remimazolam Tosilate for Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '550000', 'city': 'Guiyang', 'state': 'Guizhou', 'country': 'China', 'facility': 'The Affiliated Hospital Of Guizhou Medical University', 'geoPoint': {'lat': 26.58333, 'lon': 106.71667}}, {'zip': '610072', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': "Sichuan Provincial People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}