Post-injection Syndrome in Patients with Schizophrenia Receiving Olanzapine Long-Acting Injection (F1D-MC-B034)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/20541
• EU PAS number:
  EUPAS12592
• Study ID:
  20541
• Official title and acronym:
  Post-injection Syndrome in Patients with Schizophrenia Receiving Olanzapine Long-Acting Injection (F1D-MC-B034)
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Austria

  Belgium

  Bulgaria

  Croatia

  Czechia

  Denmark

  Finland

  France

  Germany

  Greece

  Hungary

  Ireland

  Israel

  Italy

  Lithuania

  New Zealand

  Poland

  Romania

  Slovakia

  Slovenia

  Spain

  Sweden

  United Kingdom
• Study description:
  This is a noninterventional, multi-country prospective study designed to assess the incidence of Post-Injection Syndrome events in patients treated with olanzapine long-acting injection (LAI). For the study, post-injection syndrome is defined as an event reported in temporal association with an injection of olanzapine LAI that presents with signs and symptoms consistent with olanzapine overdose. The investigator will record on the data capture form all adverse events (AEs) that occur within 24 hours following an injection and will provide a clinical opinion as to whether the patient has experienced a potential post-injection syndrome event. An adjudication committee will review all cases. The study will characterize the clinical presentation and outcomes of post-injection syndrome, as well as to seek to identify potential risk factors associated with their occurrence. Approximately 5 000 patients will enter this multi-center study to achieve 92 500 injections.
• Study status:
  Finalised

Research institution and networks

Institutions

Eli Lilly and Company

Study timelines

Date when funding contract was signed

Actual: 06/08/2008

Study start date

Actual: 07/04/2009

Date of final study report

Planned: 30/06/2016

Actual: 29/06/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Study protocol

Initial protocol

B034_protocol_amendment_c_22May2014_OSP(c)

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)