Status: Ongoing First registered on: 05/04/2016
Last updated on: 07/08/2019
1. Study identification
EU PAS Register NumberEUPAS13040
Official titlePost Authorisation Safety Study (PASS) to Evaluate the Risks of Hepatotoxicity and Nephrotoxicity from Administration of Methoxyflurane (Penthrox®) for Pain Relief in Hospital Accident & Emergency Departments in the United Kingdom
Study title acronymPenthrox-PASS
Study typeObservational study
Brief description of the studyMedical Developments UK Ltd (MDI) has applied for marketing authorisation of a liquid oral inhalation preparation of methoxyflurane (Penthrox®), for emergency relief of moderate to severe pain in conscious adult patients with trauma and associated pain, via the decentralised procedure with the Medicines and Healthcare products Regulatory Agency (MHRA). Certain safety issues (hepatotoxicity and nephrotoxicity) have been identified by the MHRA medical assessor as potential public health risks. A PASS (and risk minimisation measures which are being evaluated separately from this study) has been recommended with the primary purpose of confirming the absence of a significant risk of hepatotoxicity with use of methoxyflurane in Accident and Emergency (A&E) during routine pre-hospital clinical practice, and in hospital A&E departments.
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 Professor
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?10
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 collection14/08/201615/12/2016
Start date of data analysis01/12/2019
Date of interim report, if expected15/02/2019
Date of final study report31/01/2020
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 Professor
Last name Qizilbash
First name Nawab
Address line 116 Upper Woburn Place
Address line 2 
Address line 3 
CityLondon 
PostcodeWC1H 0AF 
CountryUnited Kingdom
Phone number (incl. country code)442037418054 
Alternative phone number 
Fax number (incl. country code) 
Email address oxon@oxonepi.com
Public Enquiries
Title Professor 
Last name Qizilbash 
First name Nawab 
Address line 116 Upper Woburn Place 
Address line 2 
Address line 3 
CityLondon 
PostcodeWC1H 0AF 
CountryUnited Kingdom 
Phone number (incl. country code)442037418054 
Alternative phone number 
Fax number (incl. country code) 
Email address oxon@oxonepi.com 
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