A non-interventional, observational study in Germany to evaluate the effectiveness of reversal of local anesthesia and occurrence of adverse events in patients treated with OraVerse® in dental office (OraNIS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/11635
• EU PAS number:
  EUPAS11634
• Study ID:
  11635
• Official title and acronym:
  A non-interventional, observational study in Germany to evaluate the effectiveness of reversal of local anesthesia and occurrence of adverse events in patients treated with OraVerse® in dental office (OraNIS)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  OraNIS was a prospective, multicenter, open-label, non-controlled, non-interventional, observational study among practicing dentists throughoutGermany in order to document the effectiveness and safety of OraVerse® afterlocal anesthetic procedures in daily routine clinical practice.
• Study status:
  Finalised

Research institutions and networks

Institutions

Sanofi

Clinical Study Unit and Winicker Norimed

15 centers Baden-Württemberg, 53 centers Bayern, 11 centers Berlin, 3 centers Brandenburg, 1 center Bremen, 4 centers Hamburg, 20 centers Hessen, 1 center Mecklenburg-Vorpommern, 9 centers Niedersachsen, 30 centers Nordrhein-Westfalen

Study timelines

Date when funding contract was signed

Actual: 01/10/2013

Study start date

Actual: 05/11/2013

Date of final study report

Actual: 27/08/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi-Aventis Deutschland GmbH

Study protocol

Initial protocol

A-301179_ORA_NIS_Beobachtungsplan_LR

Regulatory

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