Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT01189604
Status:
COMPLETED
Last Update Posted:
2011-12-19
First Post:
2010-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Dose Rate Range Finding Study of Propofol for minimal-to Moderate Sedation on Upper & Lower Endoscopic Tests
Sponsor:
Organization:
Raw JSON
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And AZ can review and revise the documents, after that, AZ will give the approval to the PI about the publication of the results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Arm 1 - Placebo', 'description': 'Infusion of placebo, same infusion rates as for arm 2', 'otherNumAtRisk': 20, 'otherNumAffected': 5, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 2 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Arm 3 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Arm 4 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute', 'otherNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Arm 5 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute', 'otherNumAtRisk': 20, 'otherNumAffected': 6, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Arm 6 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute', 'otherNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Arm 7 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute', 'otherNumAtRisk': 10, 'otherNumAffected': 2, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ventricular Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal Pain Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Blood Pressure Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Blood Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'C-Reactive Protein Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Heart Rate Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Oxygen Saturation Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Angiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - Placebo', 'description': 'Infusion of placebo, same infusion rates as for arm 2'}, {'id': 'OG001', 'title': 'Arm 2 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute'}, {'id': 'OG002', 'title': 'Arm 3 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute'}, {'id': 'OG003', 'title': 'Arm 4 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute'}, {'id': 'OG004', 'title': 'Arm 5 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute'}, {'id': 'OG005', 'title': 'Arm 6 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute'}, {'id': 'OG006', 'title': 'Arm 7 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute'}], 'classes': [{'title': 'MOAA/S Score 0-1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'MOAA/S Score 2-4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}]}, {'title': 'MOAA/S Score 5', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 minutes from the beginning of the maintenance period', 'description': "The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus \\[trapezius squeeze\\]) to 5 (Responds readily to name spoken in normal tone \\[awake\\]). MOAA/S scores were classified as 0-1, 2-4 and 5.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - Placebo', 'description': 'Infusion of placebo, same infusion rates as for arm 2'}, {'id': 'OG001', 'title': 'Arm 2 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute'}, {'id': 'OG002', 'title': 'Arm 3 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute'}, {'id': 'OG003', 'title': 'Arm 4 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute'}, {'id': 'OG004', 'title': 'Arm 5 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute'}, {'id': 'OG005', 'title': 'Arm 6 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute'}, {'id': 'OG006', 'title': 'Arm 7 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute'}], 'classes': [{'title': 'MOAA/S Score 0-1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'MOAA/S Score 2-4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}]}, {'title': 'MOAA/S Score 5', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 minutes from the beginning of the maintenance period', 'description': "The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus \\[trapezius squeeze\\]) to 5 (Responds readily to name spoken in normal tone \\[awake\\]). MOAA/S scores were classified as 0-1, 2-4 and 5.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction With Sedation Instrument (PSSI) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - Placebo', 'description': 'Infusion of placebo, same infusion rates as for arm 2'}, {'id': 'OG001', 'title': 'Arm 2 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute'}, {'id': 'OG002', 'title': 'Arm 3 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute'}, {'id': 'OG003', 'title': 'Arm 4 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute'}, {'id': 'OG004', 'title': 'Arm 5 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute'}, {'id': 'OG005', 'title': 'Arm 6 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute'}, {'id': 'OG006', 'title': 'Arm 7 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute'}], 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'spread': '21.2', 'groupId': 'OG000'}, {'value': '64.4', 'spread': '23.8', 'groupId': 'OG001'}, {'value': '74.5', 'spread': '17.1', 'groupId': 'OG002'}, {'value': '82.3', 'spread': '17.9', 'groupId': 'OG003'}, {'value': '86.0', 'spread': '9.8', 'groupId': 'OG004'}, {'value': '74.9', 'spread': '16.2', 'groupId': 'OG005'}, {'value': '75.1', 'spread': '21.2', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 - 48 hours after completion of the procedure', 'description': "The PSSI is a 100-point visual analog scale measuring a patient's satisfaction with sedation. Scores range from 0 (Very dissatisfied) to 100 (Very satisfied).", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Concentrations of Propofol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - Placebo', 'description': 'Infusion of placebo, same infusion rates as for arm 2'}, {'id': 'OG001', 'title': 'Arm 2 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute'}, {'id': 'OG002', 'title': 'Arm 3 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute'}, {'id': 'OG003', 'title': 'Arm 4 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute'}, {'id': 'OG004', 'title': 'Arm 5 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute'}, {'id': 'OG005', 'title': 'Arm 6 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute'}, {'id': 'OG006', 'title': 'Arm 7 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute'}], 'classes': [{'title': 'End of initiation period', 'categories': [{'measurements': [{'value': '0.2208', 'spread': '0.1409', 'groupId': 'OG001'}, {'value': '0.7808', 'spread': '0.3765', 'groupId': 'OG002'}, {'value': '1.5033', 'spread': '0.9468', 'groupId': 'OG003'}, {'value': '2.3177', 'spread': '1.2459', 'groupId': 'OG004'}, {'value': '1.1935', 'spread': '1.0758', 'groupId': 'OG005'}, {'value': '1.0875', 'spread': '0.7553', 'groupId': 'OG006'}]}]}, {'title': '2 minutes into maintenance period', 'categories': [{'measurements': [{'value': '0.2797', 'spread': '0.1320', 'groupId': 'OG001'}, {'value': '0.6403', 'spread': '0.3087', 'groupId': 'OG002'}, {'value': '1.1052', 'spread': '0.7197', 'groupId': 'OG003'}, {'value': '2.1827', 'spread': '0.7832', 'groupId': 'OG004'}, {'value': '1.3965', 'spread': '0.7796', 'groupId': 'OG005'}, {'value': '0.8515', 'spread': '0.6399', 'groupId': 'OG006'}]}]}, {'title': '4 minutes into maintenance period', 'categories': [{'measurements': [{'value': '0.3295', 'spread': '0.1474', 'groupId': 'OG001'}, {'value': '0.7387', 'spread': '0.3000', 'groupId': 'OG002'}, {'value': '1.2022', 'spread': '0.5612', 'groupId': 'OG003'}, {'value': '2.4360', 'spread': '0.8500', 'groupId': 'OG004'}, {'value': '1.4828', 'spread': '0.4286', 'groupId': 'OG005'}, {'value': '1.0708', 'spread': '0.7864', 'groupId': 'OG006'}]}]}, {'title': '6 minutes into maintenance period', 'categories': [{'measurements': [{'value': '0.3633', 'spread': '0.2340', 'groupId': 'OG001'}, {'value': '0.8127', 'spread': '0.2716', 'groupId': 'OG002'}, {'value': '1.4263', 'spread': '0.6700', 'groupId': 'OG003'}, {'value': '2.4714', 'spread': '0.3901', 'groupId': 'OG004'}, {'value': '1.4848', 'spread': '0.4056', 'groupId': 'OG005'}, {'value': '1.0560', 'spread': '0.7915', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the end of the initiation period and every 2 minutes during the maintenance period', 'description': 'Blood concentration of ICI35,868 (propofol)', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - Placebo', 'description': 'Infusion of placebo, same infusion rates as for arm 2'}, {'id': 'OG001', 'title': 'Arm 2 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute'}, {'id': 'OG002', 'title': 'Arm 3 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute'}, {'id': 'OG003', 'title': 'Arm 4 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute'}, {'id': 'OG004', 'title': 'Arm 5 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute'}, {'id': 'OG005', 'title': 'Arm 6 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute'}, {'id': 'OG006', 'title': 'Arm 7 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute'}], 'classes': [{'title': 'MOAA/S Score 0-1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'MOAA/S Score 2-4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'MOAA/S Score 5', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Last measurement in maintenance period (3 minutes for arms 1-5; 1 minute for arm 6, 5 minute for arm 7)', 'description': "The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus \\[trapezius squeeze\\]) to 5 (Responds readily to name spoken in normal tone \\[awake\\]). MOAA/S scores were classified as 0-1, 2-4 and 5.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1 - Placebo', 'description': 'Infusion of placebo, same infusion rates as for arm 2'}, {'id': 'FG001', 'title': 'Arm 2 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute'}, {'id': 'FG002', 'title': 'Arm 3 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute'}, {'id': 'FG003', 'title': 'Arm 4 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute'}, {'id': 'FG004', 'title': 'Arm 5 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute'}, {'id': 'FG005', 'title': 'Arm 6 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute'}, {'id': 'FG006', 'title': 'Arm 7 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '11'}, {'groupId': 'FG006', 'numSubjects': '10'}]}, {'type': 'Administered Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Impossible to visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 2 centers were initiated with first patient enrolled on 23 August 2010 and last patient completed on 17 November. A total of 129 patients were enrolled with 123 qualified patients allocated to randomized treatment.', 'preAssignmentDetails': "The patients enrolled in this study were undergoing non-emergent standard esophagogastroduodenoscopy (EGD) or colonoscopy. Six patients were withdrawn from the study after enrollment but before randomization: 5 patients due to excess recruitment and one patient due to investigator's recommendation.."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '120', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1 - Placebo', 'description': 'Infusion of placebo, same infusion rates as for arm 2'}, {'id': 'BG001', 'title': 'Arm 2 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute'}, {'id': 'BG002', 'title': 'Arm 3 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute'}, {'id': 'BG003', 'title': 'Arm 4 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute'}, {'id': 'BG004', 'title': 'Arm 5 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute'}, {'id': 'BG005', 'title': 'Arm 6 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute'}, {'id': 'BG006', 'title': 'Arm 7 - ICI35,868 (Propofol)', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.2', 'spread': '17.3', 'groupId': 'BG000'}, {'value': '51.0', 'spread': '16.4', 'groupId': 'BG001'}, {'value': '56.1', 'spread': '14.4', 'groupId': 'BG002'}, {'value': '52.0', 'spread': '14.9', 'groupId': 'BG003'}, {'value': '56.4', 'spread': '12.7', 'groupId': 'BG004'}, {'value': '49.4', 'spread': '14.2', 'groupId': 'BG005'}, {'value': '51.8', 'spread': '8.5', 'groupId': 'BG006'}, {'value': '53.2', 'spread': '14.5', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '48', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '72', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Procedures', 'classes': [{'title': 'Esophagogastroduodenoscopy (EGD)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '60', 'groupId': 'BG007'}]}]}, {'title': 'Colonoscopy', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '60', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', 'description': 'Patients underwent either esophagogastroduodenoscopy (EGD) or colonoscopy.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-15', 'studyFirstSubmitDate': '2010-08-25', 'resultsFirstSubmitDate': '2011-11-09', 'studyFirstSubmitQcDate': '2010-08-25', 'lastUpdatePostDateStruct': {'date': '2011-12-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-11-09', 'studyFirstPostDateStruct': {'date': '2010-08-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period', 'timeFrame': '2 minutes from the beginning of the maintenance period', 'description': "The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus \\[trapezius squeeze\\]) to 5 (Responds readily to name spoken in normal tone \\[awake\\]). MOAA/S scores were classified as 0-1, 2-4 and 5."}, {'measure': 'Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period', 'timeFrame': '4 minutes from the beginning of the maintenance period', 'description': "The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus \\[trapezius squeeze\\]) to 5 (Responds readily to name spoken in normal tone \\[awake\\]). MOAA/S scores were classified as 0-1, 2-4 and 5."}], 'secondaryOutcomes': [{'measure': 'Patient Satisfaction With Sedation Instrument (PSSI) Questionnaire', 'timeFrame': '24 - 48 hours after completion of the procedure', 'description': "The PSSI is a 100-point visual analog scale measuring a patient's satisfaction with sedation. Scores range from 0 (Very dissatisfied) to 100 (Very satisfied)."}, {'measure': 'Blood Concentrations of Propofol', 'timeFrame': 'At the end of the initiation period and every 2 minutes during the maintenance period', 'description': 'Blood concentration of ICI35,868 (propofol)'}, {'measure': 'Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period', 'timeFrame': 'Last measurement in maintenance period (3 minutes for arms 1-5; 1 minute for arm 6, 5 minute for arm 7)', 'description': "The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus \\[trapezius squeeze\\]) to 5 (Responds readily to name spoken in normal tone \\[awake\\]). MOAA/S scores were classified as 0-1, 2-4 and 5."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['propofol endoscopy sedation'], 'conditions': ['Gastrointestinal Endoscopy', 'Gastrointestinal Polypectomy']}, 'descriptionModule': {'briefSummary': 'Phase IIB study to find the optimal dose rate range of propofol to maintain minimal-to-moderate sedation for diagnostic gastrointestinal endoscopy and gastrointestinal polypectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female (females of child bearing potential to confirm not pregnant via test or contraception)\n* Be undergoing a non-emergent esophagogastroduodenoscopy (EGD) or colonoscopy, including polypectomy that shall be completed within 1 hour\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) grade III, IV V and VI\n* Baseline oxygen saturation\\<90% (room air)\n* Body Mass Index (BMI) \\>=35'}, 'identificationModule': {'nctId': 'NCT01189604', 'briefTitle': 'Dose Rate Range Finding Study of Propofol for minimal-to Moderate Sedation on Upper & Lower Endoscopic Tests', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Multi-centre, Single-blind, Randomised, Parallel Group, Phase IIb Dose Rate Range Finding Study to Find Maintenance Dose Rate Range of ICI35,868 for the Minimal-to-moderate Sedation on Gastrointestinal Endoscopic Tests (Including Endoscopic Polypectomy)', 'orgStudyIdInfo': {'id': 'D0092C00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Arm1 - Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2 - ICI35,868 (propofol)', 'interventionNames': ['Drug: ICI35,868 (propofol)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 3 - ICI35,868 (propofol)', 'interventionNames': ['Drug: ICI35,868 (propofol)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 4 - ICI35,868 (propofol)', 'interventionNames': ['Drug: ICI35,868 (propofol)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 5 - ICI35,868 (propofol)', 'interventionNames': ['Drug: ICI35,868 (propofol)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 6 - ICI35,868 (propofol)', 'interventionNames': ['Drug: ICI35,868 (propofol)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 7 - ICI35,868 (propofol)', 'interventionNames': ['Drug: ICI35,868 (propofol)']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Infusion of placebo, same infusion rates as for arm 2', 'armGroupLabels': ['Arm1 - Placebo']}, {'name': 'ICI35,868 (propofol)', 'type': 'DRUG', 'description': 'Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute', 'armGroupLabels': ['Arm 2 - ICI35,868 (propofol)']}, {'name': 'ICI35,868 (propofol)', 'type': 'DRUG', 'description': 'Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute', 'armGroupLabels': ['Arm 3 - ICI35,868 (propofol)']}, {'name': 'ICI35,868 (propofol)', 'type': 'DRUG', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute', 'armGroupLabels': ['Arm 4 - ICI35,868 (propofol)']}, {'name': 'ICI35,868 (propofol)', 'type': 'DRUG', 'description': 'Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute', 'armGroupLabels': ['Arm 5 - ICI35,868 (propofol)']}, {'name': 'ICI35,868 (propofol)', 'type': 'DRUG', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute', 'armGroupLabels': ['Arm 6 - ICI35,868 (propofol)']}, {'name': 'ICI35,868 (propofol)', 'type': 'DRUG', 'description': 'Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute', 'armGroupLabels': ['Arm 7 - ICI35,868 (propofol)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Isesaki', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.31667, 'lon': 139.2}}, {'city': 'Moriya', 'state': 'Ibaragi', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.93333, 'lon': 140.0}}], 'overallOfficials': [{'name': 'Masataka Date, M.D., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Physician Group, Clinical Division, R&D, Astrazeneca K.K.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Johnson & Johnson K.K. Medical Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}