Drug utilisation study (DUS) on flupirtine-containing medicinal products

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/23309
• EU PAS number:
  EUPAS12241
• Study ID:
  23309
• Official title and acronym:
  Drug utilisation study (DUS) on flupirtine-containing medicinal products
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Retrospective drug utilisation study using patient-level databases to characterise prescribing practice of flupirtine-containing medicinal products during routine clinical use and assess the main reasons for prescription by representative groups of prescribers
• Study status:
  Finalised

Research institution and networks

Institutions

Real World Evidence Solutions, IMS Health

France

Study timelines

Date when funding contract was signed

Planned: 22/09/2015

Actual: 02/11/2015

Study start date

Planned: 02/11/2015

Actual: 02/11/2015

Data analysis start date

Planned: 09/11/2015

Actual: 09/11/2015

Date of final study report

Planned: 29/02/2016

Actual: 25/02/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Lupin

Study protocol

Initial protocol

2015-09-25_DUS Flupirtine study protocol _Version3_1

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)