Oral Olanzapine Versus Haloperidol or Diazepam

November 3, 2022 updated by: Dr. Esther Wai Yin Chan, The University of Hong Kong

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Elizabeth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to achieve adequate sedation
Time Frame: Within 60 minutes from drug administration
Adequate sedation is determined by a 6-point validated scale
Within 60 minutes from drug administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour
Corrected QT interval (QTc)
Time Frame: From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour
From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour
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
From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour
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
From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

Queen Elizabeth Hospital, Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

August 8, 2017

First Submitted That Met QC Criteria

August 8, 2017

First Posted (Actual)

August 11, 2017

Study Record Updates

Last Update Posted (Actual)

November 4, 2022

Last Update Submitted That Met QC Criteria

November 3, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChanEW oral sedation RCT
  • 17111615 (Other Grant/Funding Number: Research Grant Council, Hong Kong)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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