A multinational, observational study to investigate the use of dexmedetomidine (dexdor®) in clinical practice (DEXDUS)

Study identification

• EU PAS number:
  EUPAS3243
• Study ID:
  16725
• Official title and acronym:
  A multinational, observational study to investigate the use of dexmedetomidine (dexdor®) in clinical practice (DEXDUS)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Finland

  Germany

  Poland
• Study description:
  This is a multinational, observational, retrospective drug utilisation study. All patients, both adults and children, receiving Dexdor in participating sites will have pre-defined data elements collected retrospectivelyfrom the patient medical records. The data collected will be anonymised at the source.
• Study status:
  Finalised

Research institutions and networks

Institutions

Not ENCePP centre

Multiple centres: 16 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:01/09/2011

Actual:01/09/2011

Study start date

Planned:07/05/2013

Actual:13/06/2013

Data analysis start date

Planned:29/05/2015

Actual:15/01/2015

Date of final study report

Planned:28/08/2015

Actual:13/05/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Orion Pharma

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)