Oral Olanzapine Versus Haloperidol or Diazepam

Sponsor

The University of Hong Kong (Other)

Overall Status

Terminated

CT.gov ID

NCT03246620

Collaborator

Queen Elizabeth Hospital, Hong Kong (Other)

Enrollment

Location

Arms

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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

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

Study Type:

Interventional

Actual Enrollment :

12 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 :

Sep 1, 2017

Actual Primary Completion Date :

Jun 1, 2018

Actual Study Completion Date :

Jun 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Time to achieve adequate sedation [Within 60 minutes from drug administration]
Adequate sedation is determined by a 6-point validated scale

Secondary Outcome Measures

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