Status: Finalised First registered on: 05/04/2016
Last updated on: 03/05/2019
1. Study identification
EU PAS Register NumberEUPAS13034
Official titleEvaluation of the effectiveness of Penthrox® (methoxyflurane) educational tools adopted as additional risk minimisation measures: Healthcare professional and Patient Survey.
Study title acronymPenthrox-Survey
Study typeObservational study
Brief description of the studyAs 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.
Was this study requested by a regulator?Yes: United Kingdom
Is the study required by a Risk Management Plan (RMP)? Non-EU RMP only
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsOXON
Department/Research group
Organisation/affiliationOxon Epidemiology Ltd.
Website/Homepagewww.oxonepi.com
Details of (Primary) lead investigator
Title Dr
Last name Qizilbash
First name Nawab
Is this study being carried out with the collaboration of a research network?
Yes
National Institue for Health Research (UK)
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?16
Countries in which this study is being conducted
National study

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed05/01/2016
Start date of data collection15/10/201615/12/2016
Start date of data analysis
Date of interim report, if expected
Date of final study report30/07/201814/02/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMedical Developments International100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Qizilbash
First name Nawab
Address line 1The Euston Office
Address line 21 Euston Square 
Address line 340 Melton Street 
CityLondon 
PostcodeNW1 2FD 
CountryUnited Kingdom
Phone number (incl. country code)442035744965 
Alternative phone number 
Fax number (incl. country code) 
Email address oxon@oxonepi.com
Public Enquiries
Title Dr 
Last name Qizilbash 
First name Nawab 
Address line 1The Euston Office 
Address line 21 Euston Square 
Address line 340 Melton Street 
CityLondon 
PostcodeNW1 2FD 
CountryUnited Kingdom 
Phone number (incl. country code)442035744965 
Alternative phone number 
Fax number (incl. country code) 
Email address oxon@oxonepi.com 
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