Acute AgitationPhase 4NCT03246620
Oral Olanzapine Versus Haloperidol or Diazepam
A Phase 4 study testing Olanzapine oro-dispersible 5Mg Tab, Haloperidol 2Mg encapsulated Tab and Diazepam 2Mg encapsulated Tab in people with Acute Agitation and Behavioural Emergency, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Agitation, Behavioural Emergency
- What is being tested?
- Olanzapine oro-dispersible 5Mg Tab, Haloperidol 2Mg encapsulated Tab and Diazepam 2Mg encapsulated Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2017to 1 Jun 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Accident \& Emergency Department patients
- Requiring oral drug sedation (as determined by an emergency clinician) will be enrolled.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
- Investigate oral use of sedating drugs within a predominantly Chinese population, to address this void in international literature impacting the management of acute agitation.
- 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.
- Conditions
- Acute Agitation, Behavioural Emergency
- Being tested
- Olanzapine oro-dispersible 5Mg Tab, Haloperidol 2Mg encapsulated Tab, Diazepam 2Mg encapsulated Tab
- Keywords
- emergency, emergency medicine, sedation, acute agitation
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olanzapine oro-dispersible 5Mg TabDrug
Also called Zyprexa
Patient allocated to this arm will be given 5 mg olanzapine oro-dispersible tablet and an encapsulated placebo tablet
Haloperidol 2Mg encapsulated TabDrug
Patient allocated to this arm will be given 2 mg encapsulated haloperidol tablet and an oro-dispersible placebo tablet
Diazepam 2Mg encapsulated TabDrug
Patient allocated to this arm will be given 2 mg encapsulated diazepam tablet and an oro-dispersible placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine | Experimental | oro-dispersible tablet (wafer)(Zyprexa), 5 mg, single dose Receives: Drug: Olanzapine oro-dispersible 5Mg Tab |
| Haloperidol | Active comparator | Haloperidol encapsulated tablet, 2 mg tablet, single dose Receives: Drug: Haloperidol 2Mg encapsulated Tab |
| Diazepam | Active comparator | Diazepam encapsulated tablet, 2mg tablet, single dose Receives: Drug: Diazepam 2Mg encapsulated Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to achieve adequate sedation
Adequate sedation is determined by a 6-point validated scale
Measured: Within 60 minutes from drug administration
Secondary outcomes (4)
Total study drug doses administered; alternative drugs and doses used
Measured: From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour
Corrected QT interval (QTc)
Measured: From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour
AED length of stay (LOS)
Measured: From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour
Adverse events
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
Measured: From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start1 Sep 2017
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Why it stopped: The study was terminated prematurely due to difficulties in patient recruitment and associated potential for selection bias.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acute AgitationStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Elizabeth Hospital, Hong Kong
- Responsible party
- Principal investigator, Dr. Esther Wai Yin Chan, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246620
- Sponsor's protocol ID
- ChanEW oral sedation RCT
- Other IDs
- 17111615
- Status last verified
- Nov 2022
- First submitted
- 8 Aug 2017
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16091097Chan 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.
PubMed 22981685Knott 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.
PubMed 16387219Chan 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.
PubMed 21091874Chan 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.
PubMed 19527287Chan 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.
PubMed 23186399Chan 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.
PubMed 26635127Yap 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.
PubMed 28160494
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03246620
- Acronym / sponsor ID
- ChanEW oral sedation RCT
- Conditions
- Acute Agitation, Behavioural Emergency
- Keywords
- emergency, emergency medicine, sedation, acute agitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated prematurely due to difficulties in patient recruitment and associated potential for selection bias.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Elizabeth Hospital, Hong Kong
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 11 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Investigate oral use of sedating drugs within a predominantly Chinese population, to address this void in international literature impacting the management of acute agitation.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Olanzapine | Experimental | Drug: Olanzapine oro-dispersible 5Mg Taboro-dispersible tablet (wafer)(Zyprexa), 5 mg, single dose |
| Haloperidol | Active comparator | Drug: Haloperidol 2Mg encapsulated TabHaloperidol encapsulated tablet, 2 mg tablet, single dose |
| Diazepam | Active comparator | Drug: Diazepam 2Mg encapsulated TabDiazepam encapsulated tablet, 2mg tablet, single dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Accident \& Emergency Department patients
- Requiring oral drug sedation (as determined by an emergency clinician) will be enrolled.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olanzapine oro-dispersible 5Mg TabAlso: ZyprexaPatient allocated to this arm will be given 5 mg olanzapine oro-dispersible tablet and an encapsulated placebo tablet | Drug | Olanzapine |
| Haloperidol 2Mg encapsulated TabPatient allocated to this arm will be given 2 mg encapsulated haloperidol tablet and an oro-dispersible placebo tablet | Drug | Haloperidol |
| Diazepam 2Mg encapsulated TabPatient allocated to this arm will be given 2 mg encapsulated diazepam tablet and an oro-dispersible placebo tablet | Drug | Diazepam |
Primary outcome
Time to achieve adequate sedation
Time frame: Within 60 minutes from drug administration
Adequate sedation is determined by a 6-point validated scale
4 secondary outcomes
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
Corrected QT interval (QTc)
Time frame: 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
Adverse events
Time frame: From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour
Results and safety
The study was stopped early (reason given: The study was terminated prematurely due to difficulties in patient recruitment and associated potential for selection bias.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Background: PubMed 16091097Knott 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.
- Background: PubMed 22981685Chan 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.
- Background: PubMed 16387219Knott 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.
- Background: PubMed 21091874Chan 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.
- Background: PubMed 19527287Chan 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.
- Background: PubMed 23186399Chan 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.
- Background: PubMed 26635127Chan 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.
- Background: PubMed 28160494Yap 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Olanzapine oro-dispersible 5Mg Tab, Haloperidol 2Mg encapsulated Tab and Diazepam 2Mg encapsulated Tab in people with Acute Agitation and Behavioural Emergency, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated prematurely due to difficulties in patient recruitment and associated potential for selection bias.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to achieve adequate sedation (time frame: Within 60 minutes from drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03246620, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.