A drug utilisation study to assess the effectiveness of risk minimisation measures and describe the prescribing practices of Doreta SR and tramadol/paracetamol combinations in Europe (DUS Doreta SR and tramadol/paracetamol combination)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47962
• EU PAS number:
  EUPAS47961
• Study ID:
  47962
• Official title and acronym:
  A drug utilisation study to assess the effectiveness of risk minimisation measures and describe the prescribing practices of Doreta SR and tramadol/paracetamol combinations in Europe (DUS Doreta SR and tramadol/paracetamol combination)
• DARWIN EU® study:
  No
• Study countries:
  Czechia

  Hungary

  Poland
• Study description:
  A drug utilisation study to assess the effectiveness of risk minimisation measures and describe the prescribing practices of Doreta SR and tramadol/paracetamol combinations in European countries
• Study status:
  Finalised

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 26/01/2021

Actual: 26/01/2021

Study start date

Planned: 01/12/2022

Actual: 17/01/2022

Data analysis start date

Planned: 03/04/2023

Actual: 21/06/2023

Date of final study report

Planned: 30/06/2023

Actual: 25/01/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

KRKA, d. d., Novo mesto

Study protocol

Initial protocol

KrKa Doreta SR DUS PASS protocol V3.0_17 January 2022

Updated protocol

2673514_ Krka Doreta SR DUS PASS protocol_V4_23 Feb-2023

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)

Other study registration identification numbers and links

HU/H/0190/003/II/035