Evaluation of the Effectiveness of Risk Minimisation Measures: A Survey among Health Care Professionals to Assess their Knowledge and Attitudes on Prescribing Conditions of Instanyl® in France and the Netherlands

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/16237
• EU PAS number:
  EUPAS9924
• Study ID:
  16237
• Official title and acronym:
  Evaluation of the Effectiveness of Risk Minimisation Measures: A Survey among Health Care Professionals to Assess their Knowledge and Attitudes on Prescribing Conditions of Instanyl® in France and the Netherlands
• DARWIN EU® study:
  No
• Study countries:
  France

  Netherlands
• Study description:
  A survey of prescribers of Instanyl in France and Netherlands to assess the effectiveness of education materials on safe use of Instanyl.
• Study status:
  Finalised

Research institution and networks

Institutions

Real World Evidence Solutions, IMS Health

France

Study timelines

Date when funding contract was signed

Planned: 01/03/2015

Actual: 01/03/2015

Study start date

Planned: 01/04/2015

Actual: 01/04/2015

Data analysis start date

Planned: 01/10/2015

Date of final study report

Planned: 01/03/2016

Actual: 16/11/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda Development Centre Europe

Study protocol

Initial protocol

Instanyl-5001- Protocol revised-FINAL-2015-02-06-V3

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)