Contact information
Type
Scientific
Primary contact
Mr Joel Lamoure
ORCID ID
Contact details
375 South Street
Room W707
London
N6A 4G5
Canada
+1 519 685 8500 ext 75018
Joel.lamoure@lhsc.on.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
R-06-127
Study information
Scientific title
Acronym
ROIMOPM
Study hypothesis
To review safety and tolerability of olanzapine intramuscular (IM) used outside of product monograph dosing and indications.
Ethics approval
University of Western Ontario Heath Research Ethics Board (Ref: 12254E, case number R-06-127).
Study design
Observational retrospective case report series
Primary study design
Observational
Secondary study design
Other
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/07/2006
Overall trial end date
31/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
appx 10
Participant 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.
Recruitment start date
01/07/2006
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Canada
Trial participating centre
375 South Street
London
N6A 4G5
Canada
Sponsor information
Organisation
London Health Sciences Centre (Canada)
Sponsor details
375 South Street
Room S117
London
N6A 4G5
Canada
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Eli Lilly Canada (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list