Actual conditions of use of OraVerse® in patients among resident dentists throughout Germany (OraDUS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/11651
• EU PAS number:
  EUPAS11650
• Study ID:
  11651
• Official title and acronym:
  Actual conditions of use of OraVerse® in patients among resident dentists throughout Germany (OraDUS)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  A retrospective, observational, cross-sectional drug utilisation survey among resident dentists throughout Germany to investigate the conditions of use of OraVerse® after local anesthetic procedures in daily routine clinical practice, and to investigate the use of OraVerse® according to labelling.
• Study status:
  Finalised

Research institutions and networks

Institutions

Sanofi

Clinical Study Unit and Winicker Norimed

Study timelines

Date when funding contract was signed

Actual: 09/04/2014

Study start date

Planned: 01/05/2014

Actual: 10/04/2014

Date of final study report

Planned: 01/01/2015

Actual: 16/12/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi-Aventis Deutschland GmbH

Study protocol

Initial protocol

A-301410_ORADUS_NIS_Protocol_LR

Regulatory

• Was the study required by a regulatory body?:
  No