Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-14 @ 6:05 PM
Study NCT ID:
NCT02380118
Status:
TERMINATED
Last Update Posted:
2022-11-04
First Post:
2015-01-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IM Olanzapine Versus Haloperidol or Midazolam
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077152', 'term': 'Olanzapine'}, {'id': 'D006220', 'term': 'Haloperidol'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002090', 'term': 'Butyrophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}}, 'statusModule': {'whyStopped': 'Primary endpoint reached based on data projection from interim analysis.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-03', 'studyFirstSubmitDate': '2015-01-29', 'studyFirstSubmitQcDate': '2015-03-04', 'lastUpdatePostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to achieve adequate sedation', 'timeFrame': 'Within 60 minutes from drug administration', 'description': 'Adequate sedation is determined by a 6-point validated scale.'}], 'secondaryOutcomes': [{'measure': 'Total study drug doses administered; alternative drugs and doses used', 'timeFrame': 'From Emergency Department admission to transfer or discharge from AED, an expected average of 1 hour'}, {'measure': 'Prolonged QTc interval', 'timeFrame': 'From Emergency Department admission to transfer or discharge from Emergency Department, an expected average of 1 hour'}, {'measure': 'AED length of stay (LOS)', 'timeFrame': 'From Emergency Department admission to transfer or discharge from Emergency Department, an expected average of 1 hour'}, {'measure': 'Adverse events', 'timeFrame': 'From Emergency Department admission to transfer or discharge from Emergency Department an expected average of 1 hour', 'description': 'including airway management (jaw thrust, oral, nasal airway), need for assisted ventilation (bag/mask, intubation), oxygen desaturation \\<90%, systolic BP\\<90 mmHg, dystonic reactions, seizures, vomiting or aspiration'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['emergency', 'emergency medicine', 'sedation', 'acute agitation'], 'conditions': ['Acute Agitation, Behavioural Emergency']}, 'referencesModule': {'references': [{'pmid': '16091097', 'type': 'BACKGROUND', 'citation': 'Knott JC, Bennett D, Rawet J, Taylor DM. Epidemiology of unarmed threats in the emergency department. Emerg Med Australas. 2005 Aug;17(4):351-8. doi: 10.1111/j.1742-6723.2005.00756.x.'}, {'pmid': '22981685', 'type': 'BACKGROUND', 'citation': 'Chan EW, Taylor DM, Knott JC, Phillips GA, Castle DJ, Kong DC. Intravenous droperidol or olanzapine as an adjunct to midazolam for the acutely agitated patient: a multicenter, randomized, double-blind, placebo-controlled clinical trial. Ann Emerg Med. 2013 Jan;61(1):72-81. doi: 10.1016/j.annemergmed.2012.07.118. Epub 2012 Sep 13.'}, {'pmid': '16387219', 'type': 'BACKGROUND', 'citation': 'Knott JC, Taylor DM, Castle DJ. Randomized clinical trial comparing intravenous midazolam and droperidol for sedation of the acutely agitated patient in the emergency department. Ann Emerg Med. 2006 Jan;47(1):61-7. doi: 10.1016/j.annemergmed.2005.07.003. Epub 2005 Aug 18.'}, {'pmid': '21091874', 'type': 'BACKGROUND', 'citation': 'Chan EW, Taylor DM, Knott JC, Kong DC. Variation in the management of hypothetical cases of acute agitation in Australasian emergency departments. Emerg Med Australas. 2011 Feb;23(1):23-32. doi: 10.1111/j.1742-6723.2010.01348.x. Epub 2010 Nov 22.'}, {'pmid': '19527287', 'type': 'BACKGROUND', 'citation': 'Chan EW, Knott JC, Taylor DM, Phillips GA, Kong DC. Intravenous olanzapine--another option for the acutely agitated patient? Emerg Med Australas. 2009 Jun;21(3):241-2. doi: 10.1111/j.1742-6723.2009.01190.x. No abstract available.'}, {'pmid': '23186399', 'type': 'BACKGROUND', 'citation': 'Chan EW, Taylor DM, Knott JC, Liew D, Kong DC. The pharmacoeconomics of managing acute agitation in the emergency department: what do we know and how do we approach it? Expert Rev Pharmacoecon Outcomes Res. 2012 Oct;12(5):589-95. doi: 10.1586/erp.12.53.'}, {'pmid': '33681744', 'type': 'DERIVED', 'citation': 'Chan EW, Lao KSJ, Lam L, Tsui SH, Lui CT, Wong CP, Graham CA, Cheng CH, Chung TS, Lam HF, Ting SM, Knott JC, Taylor DM, Kong DCM, Leung LP, Wong ICK. Intramuscular midazolam, olanzapine, or haloperidol for the management of acute agitation: A multi-centre, double-blind, randomised clinical trial. EClinicalMedicine. 2021 Feb 11;32:100751. doi: 10.1016/j.eclinm.2021.100751. eCollection 2021 Feb.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether intramuscular olanzapine is safer (fewer adverse events) and more effective (shorter time to sedation) than conventional haloperidol or midazolam when used in the management of acute agitation in the emergency department.', 'detailedDescription': 'To address significant knowledge gaps by several means:\n\n1. Investigate intramuscular use of sedative drugs within a predominantly Chinese population, to address this void in international literature impacting the management of acute agitation.\n\n The multi-centre RCT will determine the safety and efficacy of intramuscular olanzapine, in comparison with conventional medicines (haloperidol or midazolam) in a three-arm comparison for the sedation of acutely agitated patients in emergency department. Specifically, we aim to determine if administration of intramuscular olanzapine (a)is more effective than sedation with intramuscular haloperidol or intramuscular midazolam alone; (b)is safer than sedation with comparison arms; (c)decreases the amount of subsequent redosing or alternative drugs required; (d)is more favourable than the haloperidol and midazolam arms with respect to safety, efficacy and adverse events.\n2. Investigate potential variables leading to emergency attendance and/or admission requiring parenteral sedation. These may include patient demographics and regular medications and adherence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Emergency Department patients, requiring parenteral drug sedation (as determined by an emergency clinician) will be enrolled.\n\nExclusion Criteria:\n\n* Patients will be excluded if there are\n\n 1. known hypersensitivity or contraindication to the study drugs\n 2. reversible aetiology for agitation (e.g. hypotension, hypoxia, hypoglycaemia)\n 3. known pregnancy\n 4. acute alcohol withdrawal\n 5. patients aged\\>75 years.'}, 'identificationModule': {'nctId': 'NCT02380118', 'briefTitle': 'IM Olanzapine Versus Haloperidol or Midazolam', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Intramuscular Olanzapine Versus Haloperidol or Midazolam for the Management of Acute Agitation in the Emergency Department - a Multicentre Randomised Clinical Trial', 'orgStudyIdInfo': {'id': 'PR/CT 0309/2014 (SC)'}, 'secondaryIdInfos': [{'id': 'HKU 789813M', 'type': 'OTHER_GRANT', 'domain': 'Research Grant Council, Hong Kong'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Olanzapine', 'description': 'intramuscular olanzapine injection (zyprexa), 5 mg/dose, first dose and an optional second dose.', 'interventionNames': ['Drug: Olanzapine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Haloperidol', 'description': 'intramuscular haloperidol injection, 5 mg/dose, first dose and an optional second dose.', 'interventionNames': ['Drug: Haloperidol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Midazolam', 'description': 'intramuscular midazolam injection, 5 mg/dose, first dose and an optional second dose.', 'interventionNames': ['Drug: Midazolam']}], 'interventions': [{'name': 'Olanzapine', 'type': 'DRUG', 'otherNames': ['ZYPREXA'], 'description': 'Intramuscular injection', 'armGroupLabels': ['Olanzapine']}, {'name': 'Haloperidol', 'type': 'DRUG', 'description': 'Intramuscular injection', 'armGroupLabels': ['Haloperidol']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'Intramuscular injection', 'armGroupLabels': ['Midazolam']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Pamela Youde Nethersole Eastern Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Ruttonjee Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Tuen Mun Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'United Christian Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Esther WY Chan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Queen Mary Hospital, Hong Kong', 'class': 'OTHER'}, {'name': 'Tuen Mun Hospital', 'class': 'OTHER_GOV'}, {'name': 'Pamela Youde Nethersole Eastern Hospital', 'class': 'OTHER'}, {'name': 'Ruttonjee Hospital', 'class': 'OTHER'}, {'name': 'Prince of Wales Hospital, Shatin, Hong Kong', 'class': 'OTHER'}, {'name': 'United Christian Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dr. Esther Wai Yin Chan', 'investigatorAffiliation': 'The University of Hong Kong'}}}}