A Multicentre, Non-interventional, Prospective, Observational Drug Utilisation Study of Ayendi Nasal Spray Prescribed as Treatment in Emergency Departments in the United Kingdom (UK) (DIAPASS)

Study identification

• EU PAS number:
  EUPAS15371
• Study ID:
  32276
• Official title and acronym:
  A Multicentre, Non-interventional, Prospective, Observational Drug Utilisation Study of Ayendi Nasal Spray Prescribed as Treatment in Emergency Departments in the United Kingdom (UK) (DIAPASS)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This post-authorisation safety study (PASS) was requested by MHRA to evaluate the practical usage of the product, Ayendi, as a treatment in the Emergency Department. The study will assess the patterns of use particularly in relation to aspects that may have an impact on the safety of the product (e.g. co-medication including other opioids, medication errors). The study will also assess the effectiveness of risk minimisation activities.
• Study status:
  Finalised

Research institutions and networks

Institutions

Southmead Hospital

Multiple centres: 20 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:15/04/2013

Actual:04/08/2016

Study start date

Planned:01/12/2016

Actual:11/01/2017

Data analysis start date

Planned:30/01/2019

Actual:28/03/2019

Date of interim report, if expected

Planned:01/06/2016

Actual:25/04/2018

Date of final study report

Planned:01/09/2019

Actual:04/11/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Wockhardt (UK) Limited

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)