An Evaluation of the Misuse and Abuse of Pregabalin using RADARS® System Programs in the United States and the European Union

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/29172
• EU PAS number:
  EUPAS24790
• Study ID:
  29172
• Official title and acronym:
  An Evaluation of the Misuse and Abuse of Pregabalin using RADARS® System Programs in the United States and the European Union
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  United States
• Study description:
  The primary objectives of this evaluation:1) Summarize misuse and abuse data for pregabalin and each comparator within each country for each data source2) Perform a statistical analysis of trends over time for pregabalin and each comparator to assess changes in misuse and abuse within each country and data source
• Study status:
  Finalised

Research institutions and networks

Institutions

RADARS® System

Cystic Fibrosis Trust

Study timelines

Date when funding contract was signed

Actual: 06/06/2018

Study start date

Planned: 15/06/2018

Actual: 15/06/2018

Data analysis start date

Planned: 30/06/2018

Actual: 30/06/2018

Date of final study report

Planned: 30/10/2018

Actual: 17/10/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

RADARS System Pregabalin Study Protocol 06June2018 FINAL

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

A0081363