Instanyl-5002: Assessment of the Effectiveness of Updated Educational Materials on Prescribers’ Knowledge and Behavior with Respect to Risks Associated with INSTANYL® Off-Label Use

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50156
• EU PAS number:
  EUPAS41308
• Study ID:
  50156
• Official title and acronym:
  Instanyl-5002: Assessment of the Effectiveness of Updated Educational Materials on Prescribers’ Knowledge and Behavior with Respect to Risks Associated with INSTANYL® Off-Label Use
• DARWIN EU® study:
  No
• Study countries:
  France

  Netherlands

  Poland
• Study description:
  The purpose of the Instanyl study is to learn how much doctors know and understand about Instanyl® before and after they receive updated educational information, including the risks of its unapproved use. In this study, the doctors will complete two surveys: one three months before they receive the updated educational information, and one about six months after they receive this information. They will answer questions about their prescribing behavior plus their knowledge of Instanyl® including any risks.
• Study status:
  Finalised

Research institutions and networks

Institutions

Takeda

Study timelines

Date when funding contract was signed

Actual: 05/01/2020

Study start date

Planned: 01/02/2022

Actual: 18/02/2022

Data analysis start date

Planned: 01/04/2023

Date of interim report, if expected

Actual: 19/09/2022

Date of final study report

Planned: 30/09/2023

Actual: 20/09/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Study protocol

Initial protocol

Instanyl-5002_PASS_Protocol-V2-Redacted

Updated protocol

Instanyl-5002_PASS Protocol v3.0_Amendment v1.0_CLEAN_FINAL_Redacted_17JUL2023

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)