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 |
| Protocol serial number | R-06-127 |
| Sponsor | London Health Sciences Centre (Canada) |
| Funder | Eli Lilly Canada (Canada) |
- Submission date
- 25/06/2006
- Registration date
- 31/08/2006
- Last edited
- 07/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Joel Lamoure
Scientific
Scientific
375 South Street
Room W707
London
N6A 4G5
Canada
| Phone | +1 519 685 8500 ext 75018 |
|---|---|
| Joel.lamoure@lhsc.on.ca |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational retrospective case report series |
| Secondary study design | Other |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Olanzapine intramuscular |
| Primary outcome measure(s) |
Risk/benefit assessment of olanzapine IM being used in the included patients. |
| Key secondary outcome measure(s) |
Demographics and concurrent medications resulting in therapeutic issues (post-marketing surveillance). |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Canada
Study participating centre
375 South Street
London
N6A 4G5
Canada
N6A 4G5
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2011 | 07/01/2021 | Yes | No |
Editorial Notes
07/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
