Drug Utilization Study (DUS) and post authorization safety study (PASS) on the fixed combination Tramadol-Dexketoprofen (DKP-TRAM)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/46777
• EU PAS number:
  EUPAS24858
• Study ID:
  46777
• Official title and acronym:
  Drug Utilization Study (DUS) and post authorization safety study (PASS) on the fixed combination Tramadol-Dexketoprofen (DKP-TRAM)
• DARWIN EU® study:
  No
• Study countries:
  Italy

  Spain
• Study description:
  To evaluate pattern of prescription of DKP-TRAM and assess the risk of adverse events in DKP-TRAM vs. Tramadol monotherapy users with a special focus on patients 75 year-old and over
• Study status:
  Finalised

Research institutions and networks

Institutions

Health Search, Italian College of General Practicioners

Italy

Multiple centres: 2 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 06/06/2018

Study start date

Planned: 01/01/2017

Actual: 01/01/2017

Data analysis start date

Planned: 01/01/2017

Actual: 01/01/2017

Date of interim report, if expected

Planned: 31/01/2021

Actual: 31/01/2021

Date of final study report

Planned: 10/08/2021

Actual: 10/08/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Menarini International Operations Luxembourg

Study protocol

Initial protocol

protocollo finale versione 1

Updated protocol

protocollo finale versione 3

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)