Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-25 @ 5:31 PM
Study NCT ID:
NCT06124404
Status:
COMPLETED
Last Update Posted:
2024-02-05
First Post:
2023-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Step 1 of A Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Sedation in ICU Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-01', 'studyFirstSubmitDate': '2023-09-29', 'studyFirstSubmitQcDate': '2023-11-07', 'lastUpdatePostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cmax', 'timeFrame': 'Within 24 hours while receiving the study drug', 'description': 'peak plasma concentration'}, {'measure': 'The area under the plasma drug concentration-time curve', 'timeFrame': 'Within 24 hours while receiving the study drug', 'description': 'The area under the plasma drug concentration-time curve (AUC)'}, {'measure': 't1/2', 'timeFrame': 'Within 24 hours while receiving the study drug', 'description': 'half-life'}], 'primaryOutcomes': [{'measure': 'The percentage of time in the target sedation range without rescue sedation', 'timeFrame': 'Within 24 hours while receiving the study drug', 'description': 'The percentage of time in the target sedation range without rescue sedation'}], 'secondaryOutcomes': [{'measure': 'The number and severity of treatment emergent adverse events (TEAEs)', 'timeFrame': 'Within 48 hours after the stop of the study drug', 'description': 'The number and severity of treatment emergent adverse events (TEAEs)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mechanically Ventilated Patients']}, 'descriptionModule': {'briefSummary': 'This is a Phase II, dose-escalation clinical trial conducted in mechanically ventilated patients receiving sedation no longer than 24 hours. The efficacy, safety, and pharmacokinetics of remimazolam besylate were evaluated using a randomized, single-blind design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) ≥18 and ≤ 30 kg/m2\n* Being Intubated and mechanically ventilated ≤48 hours before enrollment and expected to be on a ventilator for at least 6 hours\n* Requirement for light to moderate sedation (a Richmond agitation-sedation scale score of -2 to 1)\n\nExclusion Criteria:\n\n* Refusal to be included\n* Allergy or unsuitability to any composition of study drugs or remifentanil\n* Living expectancy less than 48 hours\n* Myasthenia gravis\n* Status asthmaticus\n* Abdominal compartment syndrome\n* Serious hepatic dysfunction (CTP 10-15);\n* Chronic kidney disease with glomerular filtration rate (GFR) \\< 29 ml/min/1.73m2\n* Mean blood pressure less than 65 mm Hg or the need for a continuous infusion of norepinephrine at ≥0.5 ug/kg/min to maintain Mean blood pressure ≥ 65 mm Hg\n* Possible requirement for surgery or bedside tracheostomy in 24 hours\n* Possible requirement for renal replacement therapy in 24 hours\n* Acute severe neurological disorder and any other condition interfering with sedation assessment\n* Abuse of controlled substances or alcohol\n* Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT06124404', 'briefTitle': 'Step 1 of A Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Sedation in ICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'A Multicenter, Randomized, Single-blinded, Parallel, Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Injection for Sedation in ICU Patients', 'orgStudyIdInfo': {'id': 'WHUICU202205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Small dose', 'interventionNames': ['Drug: Remimazolam besylate']}, {'type': 'EXPERIMENTAL', 'label': 'Medium dose', 'interventionNames': ['Drug: Remimazolam besylate']}, {'type': 'EXPERIMENTAL', 'label': 'Large dose', 'interventionNames': ['Drug: Remimazolam besylate']}], 'interventions': [{'name': 'Remimazolam besylate', 'type': 'DRUG', 'otherNames': ['A maintaining dose of 0.1mg/kg/h'], 'description': 'After a loading dose of 0.08mg/kg, a maintaining dose of 0.1mg/kg/h is given', 'armGroupLabels': ['Small dose']}, {'name': 'Remimazolam besylate', 'type': 'DRUG', 'otherNames': ['A maintaining dose of 0.2mg/kg/h'], 'description': 'After a loading dose of 0.08mg/kg, a maintaining dose of 0.2mg/kg/h is given', 'armGroupLabels': ['Medium dose']}, {'name': 'Remimazolam besylate', 'type': 'DRUG', 'otherNames': ['A maintaining dose of 0.4mg/kg/h'], 'description': 'After a loading dose of 0.08mg/kg, a maintaining dose of 0.4mg/kg/h is given', 'armGroupLabels': ['Large dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Wuhan Union Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yichang Humanwell Pharmaceutical Co., Ltd., China', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}