Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000280404
Ethics application status
Not yet submitted
Date submitted
22/11/2006
Date registered
28/05/2007
Date last updated
28/05/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
A single-centre, randomized comparsion of the Efficacy and Safety of Intramuscular Olanzapine and Haloperidol in Treating Acutely Agitated patients in Emergency Department
Scientific title
A single-centre, randomized comparsion of the Efficacy and Safety of Intramuscular Olanzapine and Haloperidol in Treating Acutely Agitated patients in Emergency Department
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sedation for the acutely agitated patients 1820 0
Condition category
Condition code
Other 1911 1911 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients are randomized to either olanzapine or haloperidol groups. The study aim is to compare the time for sedation of acutely agitated patients in the olanzapine group (new treatment) with haloperidol group (traditional treatment). The duration of intervention is about 30 minutes after single dose of study drug. The dose of olanzapine and haloperidol are both intramuscularly 10mg. The estimated study period will be approximately one year and the sample size is approx 140 in each study group i.e. 280 subjects in total.
Intervention code [1] 1460 0
Treatment: Drugs
Comparator / control treatment
Haloperidol group (traditional treatment).
Control group
Active

Outcomes
Primary outcome [1] 2722 0
Time to sedation
Timepoint [1] 2722 0
Measured from the time of administration of the study drug till the sedation scale (modified Thomas Combativeness scale) to 3 i.e. no agitation and no supervision required and time
Primary outcome [2] 2723 0
Time to arousal defined as if the patient awakens to verbal commands, is able to count backwards from 10 to 1 and is able to follow simple commands
Timepoint [2] 2723 0
Measured from the time of administration of the study drugs
Secondary outcome [1] 4587 0
Any adverse events of drugs, that occurs during the intervention/study period.
Timepoint [1] 4587 0
Within 30 minutes.

Eligibility
Key inclusion criteria
Acute agitation that required chemical restraint.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Readily reversible aetiology for the agitationhypotensionknown allergy to either drugvisible or suspected head traumaunable to maintain their own airwayin respiratory distressknown pregnancyknown Parkinson's disease or Lewy Body Dementiaaged

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects and therapist are blinded
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
280
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2057 0
Hospital
Name [1] 2057 0
Peninsula Health
Country [1] 2057 0
Australia
Primary sponsor type
Hospital
Name
Peninsula Health (Emergency Department)
Address
Country
Australia
Secondary sponsor category [1] 1864 0
None
Name [1] 1864 0
No secondary sponsor
Address [1] 1864 0
Country [1] 1864 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3822 0
Peninsula Health
Ethics committee address [1] 3822 0
Ethics committee country [1] 3822 0
Australia
Date submitted for ethics approval [1] 3822 0
Approval date [1] 3822 0
Ethics approval number [1] 3822 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27394 0
Address 27394 0
Country 27394 0
Phone 27394 0
Fax 27394 0
Email 27394 0
Contact person for public queries
Name 10649 0
Dr Barry Chan
Address 10649 0
Frankston Hospital
Hastings Road
Frankston VIC 3199
Country 10649 0
Australia
Phone 10649 0
+61 3 97847777
Fax 10649 0
+61 3 97847284
Email 10649 0
[email protected]
Contact person for scientific queries
Name 1577 0
Dr Barry Chan
Address 1577 0
Frankston Hospital
Hastings Road
Frankston VIC 3199
Country 1577 0
Australia
Phone 1577 0
+61 3 97847777
Fax 1577 0
+61 3 97847284
Email 1577 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.