Evaluation of the effectiveness of Penthrox® (methoxyflurane) educational tools adopted as additional risk minimisation measures: Healthcare professional and Patient Survey (Penthrox-Survey)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/29622
• EU PAS number:
  EUPAS13034
• Study ID:
  29622
• Official title and acronym:
  Evaluation of the effectiveness of Penthrox® (methoxyflurane) educational tools adopted as additional risk minimisation measures: Healthcare professional and Patient Survey (Penthrox-Survey)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  As a condition to the marketing authorisation of Penthrox (methoxyflurane), a HCP administration guide and checklist and a patient alert card have been developed to increase awareness of important risks associated with methoxyflurane use and of the best course of actions to minimise those risks. In line with regulatory guidance, a survey of HCPs and patients is proposed to assess whether the processes put in place for the Penthrox educational efforts are effective in achieving a desirable understanding of and behaviour upon key safety messages related to the use of Penthrox.
• Study status:
  Finalised

Research institution and networks

Institutions

OXON Epidemiology

Spain

United Kingdom

National Institue for Health Research (UK), Multiple centres: 16 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 05/01/2016

Study start date

Planned: 15/10/2016

Actual: 15/12/2016

Date of final study report

Planned: 30/07/2018

Actual: 14/02/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Medical Developments International

Regulatory

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