A retrospective case report series of patients (post-marketing) Receiving Olanzapine IntraMuscular Outside of Product Monograph doses and indications: assessing safety and tolerability

ISRCTN	ISRCTN76803177
DOI	https://doi.org/10.1186/ISRCTN76803177
Secondary identifying numbers	R-06-127

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Joel Lamoure
Scientific

375 South Street
Room W707
London
N6A 4G5
Canada

Phone	+1 519 685 8500 ext 75018
Email	Joel.lamoure@lhsc.on.ca

Study design	Observational retrospective case report series
Primary study design	Observational
Secondary study design	Other
Study setting(s)	Not specified
Study type	Treatment
Scientific title	A retrospective case report series of patients (post-marketing) Receiving Olanzapine IntraMuscular Outside of Product Monograph doses and indications: assessing safety and tolerability
Study acronym	ROIMOPM
Study objectives	To review safety and tolerability of olanzapine intramuscular (IM) used outside of product monograph dosing and indications.
Ethics approval(s)	University of Western Ontario Heath Research Ethics Board (Ref: 12254E, case number R-06-127).
Health condition(s) or problem(s) studied	Various mental disorders under Diagnostic and Statistical Manual of mental disorders fourth edition (DSM-IV)
Intervention	The intervention will be based on clinicians observations where the included patients have recieved Olanzapine IM.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Olanzapine intramuscular
Primary outcome measure	Risk/benefit assessment of olanzapine IM being used in the included patients.
Secondary outcome measures	Demographics and concurrent medications resulting in therapeutic issues (post-marketing surveillance).
Overall study start date	01/07/2006
Completion date	31/12/2007

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	appx 10
Total final enrolment	8
Key inclusion criteria	Patients whom have received Olanzapine IM in doses exceeding doses stated in literature or for uses not listed in the current edition of the Compendium of Pharmaceuticals and Specialties.
Key exclusion criteria	Patients under 16 or over 70 years of age, or those whom have a documented allergy or sensitivity to olanzapine, also patients whom have used the olanzapine IM within normal dosing parameters.
Date of first enrolment	01/07/2006
Date of final enrolment	31/12/2007

375 South Street

London
N6A 4G5
Canada

London Health Sciences Centre (Canada)
Hospital/treatment centre

375 South Street
Room S117
London
N6A 4G5
Canada

Website	http://www.lhsc.on.ca/
"ROR"	https://ror.org/037tz0e16

Industry

Eli Lilly Canada (Canada)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2011	07/01/2021	Yes	No

07/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.