Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT01271569
Status:
COMPLETED
Last Update Posted:
2011-01-06
First Post:
2011-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Efficacy and Safety of Fospropofol Disodium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C472965', 'term': 'fospropofol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-05', 'studyFirstSubmitDate': '2011-01-05', 'studyFirstSubmitQcDate': '2011-01-05', 'lastUpdatePostDateStruct': {'date': '2011-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BIS', 'timeFrame': '2hr after administration'}], 'secondaryOutcomes': [{'measure': 'Modified OAA/S Score', 'timeFrame': '2hr after administration'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Drug Safety']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the pharmacodynamics, safety, and tolerability of Fospropofol disodium up to a dose producing maximal hypnotic effect as defined by electroencephalogramderived assessment (Bispectral Index \\[BIS\\]) and to compare the dynamic properties of PropofolF to those of Propofol.', 'detailedDescription': 'After local ethics committee (West China Hospital, Sichuan University, Chengdu, China) approval and written informed consent were obtained, 80 healthy volunteers (40 males and 40 females) aged between 18 and 45 yr were included. For 1 week before the study, subjects were to follow a diet with limited amounts of alcohol and caffeine. Ingestion of caffeine, alcohol, products containing aspartame (aspartame may increase formate concentrations), or use of paracetamol within 24 h before study drug administration resulted in ineligibility. Exclusion criteria included hypersensitivity to any anesthetic; known or suspected serious disorders and/or significant dysfunction; an abnormal, clinically significant ECG finding; participation in an investigational drug study within the previous month; known or suspected pregnancy; anatomical malformations expected to produce a difficult intubation and known or suspected history or family history of malignant hyperthermia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* After local ethics committee (West China Hospital, Sichuan University, Chengdu, China) approval and written informed consent were obtained, 80 healthy volunteers (40 males and 40 females) aged between 18 and 45 yr were included. For 1 week before the study, subjects were to follow a diet with limited amounts of alcohol and caffeine.\n\nExclusion Criteria:\n\n* Exclusion criteria included hypersensitivity to any anesthetic; known or suspected serious disorders and/or significant dysfunction; an abnormal, clinically significant ECG finding; participation in an investigational drug study within the previous month; known or suspected pregnancy; anatomical malformations expected to produce a difficult intubation and known or suspected history or family history of malignant hyperthermia.'}, 'identificationModule': {'nctId': 'NCT01271569', 'briefTitle': 'A Study to Assess the Efficacy and Safety of Fospropofol Disodium', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'A Phase 1,Open, Dose-escalation Study to Assess the Efficacy and Safety of Fospropofol Disodium Injection in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'SFDA2009L09746'}, 'secondaryIdInfos': [{'id': '2009L09746', 'type': 'OTHER', 'domain': 'the State Food and Drug Administration in China'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'In the treatment arm', 'interventionNames': ['Drug: Fospropofol disodium']}], 'interventions': [{'name': 'Fospropofol disodium', 'type': 'DRUG', 'description': 'Fospropofol disodium： 0.5g', 'armGroupLabels': ['In the treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'overallOfficials': [{'name': 'Jin Liu, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'West China Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'West China Hospital, Sichuan University', 'oldOrganization': 'West China Hospital, Sichuan University'}}}}