Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-03-03 @ 3:16 PM
Study NCT ID:
NCT03246620
Status:
TERMINATED
Last Update Posted:
2022-11-04
First Post:
2017-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Olanzapine Versus Haloperidol or Diazepam
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': 'D003975', 'term': 'Diazepam'}], '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'}, {'id': 'D001570', 'term': 'Benzodiazepinones'}]}}, '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': 12}}, 'statusModule': {'whyStopped': 'The study was terminated prematurely due to difficulties in patient recruitment and associated potential for selection bias.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-03', 'studyFirstSubmitDate': '2017-08-08', 'studyFirstSubmitQcDate': '2017-08-08', 'lastUpdatePostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', '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 Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour'}, {'measure': 'Corrected QT interval (QTc)', 'timeFrame': 'From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour'}, {'measure': 'AED length of stay (LOS)', 'timeFrame': 'From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour'}, {'measure': 'Adverse events', 'timeFrame': 'From Accident & Emergency Department(AED) admission to transfer or discharge from AED, 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': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, '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': '26635127', 'type': 'BACKGROUND', 'citation': 'Chan EW, Tang C, Lao KS, Ling Pong L, Tsui MS, Ho HF, Wong GC, Kong DC, McD Taylor D, Knott JC, Wong IC. Management of acute agitation in Hong Kong and comparisons with Australasia. Emerg Med Australas. 2015 Dec;27(6):542-548. doi: 10.1111/1742-6723.12499. Epub 2015 Dec 3.'}, {'pmid': '28160494', 'type': 'BACKGROUND', 'citation': 'Yap CYL, Taylor DM, Knott JC, Taylor SE, Phillips GA, Karro J, Chan EW, Kong DCM, Castle DJ. Intravenous midazolam-droperidol combination, droperidol or olanzapine monotherapy for methamphetamine-related acute agitation: subgroup analysis of a randomized controlled trial. Addiction. 2017 Jul;112(7):1262-1269. doi: 10.1111/add.13780. Epub 2017 Feb 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether oral olanzapine is safer (fewer adverse events) and more effective (shorter time to sedation) than conventional haloperidol or diazepam when used in the management of acute agitation in the emergency.', 'detailedDescription': '1. Investigate oral use of sedating drugs within a predominantly Chinese population, to address this void in international literature impacting the management of acute agitation.\n2. The multi-centre Randomised Clinical Trial will determine the safety and efficacy of oral olanzapine, in comparison with conventional medicines (haloperidol or diazepam) in a three-arm comparison for the sedation of acutely agitated patients in AEDs. Specifically, we aim to determine if administration of oral olanzapine (a)is more effective than sedation with oral haloperidol or oral diazepam 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 diazepam arms with respect to safety, efficacy and adverse events.\n\nInvestigate potential variables leading to AED attendance and/or admission requiring oral sedation. These may include patient demographic 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* Accident \\& Emergency Department patients\n* Requiring oral drug sedation (as determined by an emergency clinician) will be enrolled.\n\nExclusion Criteria:\n\n* known hypersensitivity or contraindication to the study drugs\n* reversible aetiology for agitation (e.g. hypotension, hypoxia, hypoglycaemia)\n* known pregnancy\n* acute alcohol withdrawal\n* refusal to take oral medication\n* patients from correctional facilities'}, 'identificationModule': {'nctId': 'NCT03246620', 'briefTitle': 'Oral Olanzapine Versus Haloperidol or Diazepam', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Oro-dispersible Olanzapine (Wafer) Versus Conventional Oral Haloperidol or Diazepam Tablets for the Management of Acute Agitation in the Accident and Emergency Department - a Multicentre Randomised Clinical Trial', 'orgStudyIdInfo': {'id': 'ChanEW oral sedation RCT'}, 'secondaryIdInfos': [{'id': '17111615', 'type': 'OTHER_GRANT', 'domain': 'Research Grant Council, Hong Kong'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Olanzapine', 'description': 'oro-dispersible tablet (wafer)(Zyprexa), 5 mg, single dose', 'interventionNames': ['Drug: Olanzapine oro-dispersible 5Mg Tab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Haloperidol', 'description': 'Haloperidol encapsulated tablet, 2 mg tablet, single dose', 'interventionNames': ['Drug: Haloperidol 2Mg encapsulated Tab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diazepam', 'description': 'Diazepam encapsulated tablet, 2mg tablet, single dose', 'interventionNames': ['Drug: Diazepam 2Mg encapsulated Tab']}], 'interventions': [{'name': 'Olanzapine oro-dispersible 5Mg Tab', 'type': 'DRUG', 'otherNames': ['Zyprexa'], 'description': 'Patient allocated to this arm will be given 5 mg olanzapine oro-dispersible tablet and an encapsulated placebo tablet', 'armGroupLabels': ['Olanzapine']}, {'name': 'Haloperidol 2Mg encapsulated Tab', 'type': 'DRUG', 'description': 'Patient allocated to this arm will be given 2 mg encapsulated haloperidol tablet and an oro-dispersible placebo tablet', 'armGroupLabels': ['Haloperidol']}, {'name': 'Diazepam 2Mg encapsulated Tab', 'type': 'DRUG', 'description': 'Patient allocated to this arm will be given 2 mg encapsulated diazepam tablet and an oro-dispersible placebo tablet', 'armGroupLabels': ['Diazepam']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Queen Elizabeth Hospital, Hong Kong', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dr. Esther Wai Yin Chan', 'investigatorAffiliation': 'The University of Hong Kong'}}}}