Non-interventional post-authorization study on effectiveness of reversal of local anaesthesia and on the occurrence of local reactions and cardiovascular adverse events in patients treated with OraVerse® versus patients not treated with OraVerse® (control group) in Germany (ORAPAES)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33005
• EU PAS number:
  EUPAS4062
• Study ID:
  33005
• Official title and acronym:
  Non-interventional post-authorization study on effectiveness of reversal of local anaesthesia and on the occurrence of local reactions and cardiovascular adverse events in patients treated with OraVerse® versus patients not treated with OraVerse® (control group) in Germany (ORAPAES)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Non-interventional post-authorization study on effectiveness of reversal of local anaesthesia and on the occurrence of local reactions and cardiovascular adverse events in patients treated with OraVerse® versus patients not treated with OraVerse® (control group) in Germany
• Study status:
  Finalised

Research institutions and networks

Institutions

Sanofi

Multiple centres: 12 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 31/12/2012

Actual: 31/12/2012

Study start date

Planned: 15/06/2013

Actual: 15/06/2013

Data analysis start date

Planned: 15/07/2014

Actual: 05/01/2015

Date of final study report

Planned: 15/06/2015

Actual: 30/06/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi

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)