Post 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 (Penthrox-PASS)

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS13040
• Study ID:
  30864
• Official title and acronym:
  Post 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 (Penthrox-PASS)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Medical Developments UK Ltd (MDI) applied for marketing authorisation for a liquid inhalation preparation of methoxyflurane (Penthrox®) for the emergency relief of moderate-to-severe pain in conscious adult patients with trauma, through the decentralised procedure with the Medicines and Healthcare products Regulatory Agency (MHRA). Certain safety concerns, namely hepatotoxicity and nephrotoxicity, were identified by the MHRA medical assessor as potential public health risks. Consequently, a post-authorisation safety study (PASS), together with risk minimisation measures that are being evaluated separately from this study, was recommended. The primary purpose of the PASS is to confirm the absence of a significant risk of hepatotoxicity associated with the use of methoxyflurane in routine pre-hospital clinical practice and in hospital Accident and Emergency (A&E) departments.
• Study status:
  Finalised

Research institutions and networks

Institutions

OXON Epidemiology

Spain

United Kingdom

Networks

NIHR Medicines for Children Research Network

Study timelines

Date when funding contract was signed

Actual:05/01/2016

Study start date

Planned:14/08/2016

Actual:15/12/2016

Data analysis start date

Planned:01/12/2019

Date of interim report, if expected

Planned:15/02/2019

Date of final study report

Planned:31/01/2020

Actual:16/10/2020

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