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Oral Olanzapine Versus Haloperidol or Diazepam

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ClinicalTrials.gov Identifier: NCT03246620
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
Queen Elizabeth Hospital, Hong Kong
Information provided by (Responsible Party):
Dr. Esther Wai Yin Chan, The University of Hong Kong

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Agitation Behavioural Emergency Drug: Olanzapine oro-dispersible 5Mg Tab Drug: Haloperidol 2Mg encapsulated Tab Drug: Diazepam 2Mg encapsulated Tab Phase 4

Detailed Description:
  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.
  2. 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.

Investigate potential variables leading to AED attendance and/or admission requiring oral sedation. These may include patient demographic and regular medications and adherence.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Olanzapine
oro-dispersible tablet (wafer)(Zyprexa), 5 mg, single dose
Drug: Olanzapine oro-dispersible 5Mg Tab
Patient allocated to this arm will be given 5 mg olanzapine oro-dispersible tablet and an encapsulated placebo tablet
Other Name: Zyprexa

Active Comparator: Haloperidol
Haloperidol encapsulated tablet, 2 mg tablet, single dose
Drug: Haloperidol 2Mg encapsulated Tab
Patient allocated to this arm will be given 2 mg encapsulated haloperidol tablet and an oro-dispersible placebo tablet

Active Comparator: Diazepam
Diazepam encapsulated tablet, 2mg tablet, single dose
Drug: Diazepam 2Mg encapsulated Tab
Patient allocated to this arm will be given 2 mg encapsulated diazepam tablet and an oro-dispersible placebo tablet




Primary Outcome Measures :
  1. Time to achieve adequate sedation [ Time Frame: Within 60 minutes from drug administration ]
    Adequate sedation is determined by a 6-point validated scale


Secondary Outcome Measures :
  1. Total study drug doses administered; alternative drugs and doses used [ Time Frame: From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour ]
  2. Corrected QT interval (QTc) [ Time Frame: From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour ]
  3. AED length of stay (LOS) [ Time Frame: From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour ]
  4. Adverse events [ Time Frame: From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour ]
    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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Accident & Emergency Department patients
  • Requiring oral drug sedation (as determined by an emergency clinician) will be enrolled.

Exclusion Criteria:

  • known hypersensitivity or contraindication to the study drugs
  • reversible aetiology for agitation (e.g. hypotension, hypoxia, hypoglycaemia)
  • known pregnancy
  • acute alcohol withdrawal
  • refusal to take oral medication
  • patients from correctional facilities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03246620


Contacts
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Contact: Esther W Chan, PhD 852 6716 0700 ewchan@hku.hk
Contact: Lam Lam, Bsc 2831 5109 laml2911@hku.hk

Locations
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Hong Kong
Queen Elizabeth Hospital Recruiting
Hong Kong, Hong Kong
Contact: Kin Ling Chan         
Sponsors and Collaborators
The University of Hong Kong
Queen Elizabeth Hospital, Hong Kong

Publications:

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Responsible Party: Dr. Esther Wai Yin Chan, Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03246620     History of Changes
Other Study ID Numbers: ChanEW oral sedation RCT
17111615 ( Other Grant/Funding Number: Research Grant Council, Hong Kong )
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dr. Esther Wai Yin Chan, The University of Hong Kong:
emergency
emergency medicine
sedation
acute agitation
Additional relevant MeSH terms:
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Psychomotor Agitation
Emergencies
Disease Attributes
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Diazepam
Haloperidol
Olanzapine
Haloperidol decanoate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Dopamine Antagonists