Drug Utilisation Study of Intuniv® (guanfacine extended release) in European Countries, Study protocol I: Database study (Intuniv data base study Europe)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48508
• EU PAS number:
  EUPAS18735
• Study ID:
  48508
• Official title and acronym:
  Drug Utilisation Study of Intuniv® (guanfacine extended release) in European Countries, Study protocol I: Database study (Intuniv data base study Europe)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Germany

  Norway

  Spain

  Sweden

  United Kingdom
• Study description:
  This is a multi-country drug utilization study using retrospective database analysis. A single database for all target countries is not available. Therefore an approach was chosen which includes multiple data sources to gather drug utilization data for Intuniv in European target countries. In case longitudinal patient level data do not exist in a target country, a prescriber survey will be conducted, which is described in a separate protocol.
• Study status:
  Finalised

Research institution and networks

Institutions

Real World Solutions, IQVIA

Netherlands

United Kingdom (Northern Ireland)

Study timelines

Date when funding contract was signed

Planned: 30/08/2016

Actual: 30/08/2016

Study start date

Planned: 01/02/2019

Actual: 15/11/2018

Date of interim report, if expected

Planned: 30/06/2019

Actual: 11/06/2019

Date of final study report

Planned: 30/06/2023

Actual: 01/05/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda Pharmaceutical Company Limited

Study protocol

Initial protocol

INTUNIV EU DUS_DATABASE Protocol v7.0_17Jul2018clean-redact.pdf

Updated protocol

INTUNIV_EU_DUS_Protocol Amend v7.2_CLEAN_FINAL_26-JUL-2022_redacted.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)