Condition category
Mental and Behavioural Disorders
Date applied
25/06/2006
Date assigned
31/08/2006
Last edited
31/08/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.lhsc.on.ca/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes