DARWIN EU® Drug utilisation study of medicines with prokinetic properties in children and adults diagnosed with gastroparesis

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/107280
• EU PAS number:
  EUPAS106798
• Study ID:
  107280
• Official title and acronym:
  DARWIN EU® Drug utilisation study of medicines with prokinetic properties in children and adults diagnosed with gastroparesis
• DARWIN EU® study:
  Yes
• Study countries:
  Belgium

  France

  Germany

  Netherlands

  Spain

  United Kingdom
• Study description:
  Gastroparesis is a medical condition characterized by delayed gastric emptying, causing symptoms like postprandial fullness, nausea, vomiting, and upper abdominal pain. It affects individuals across different age groups, encompassing both paediatric population and adults. Pharmacotherapy, particularly medication with prokinetic properties, has been used to manage symptoms, which includes off-label use. The European Medicines Agency commissioned this DARWIN EU© CC study to: describe the characteristics of children and adults prescribed medications with prokinetic properties stratified by indication of use (gastroparesis), to determine the dose, formulation, cumulative duration and setting at time of treatment initiation of any of the prokinetic drugs of interest for patients diagnosed with gastroparesis, in children and adults separately, and to determine the incidence and prevalence of use of medications with prokinetics properties for patients diagnosed with gastroparesis, in the paediatric population and in adults separately, stratified by calendar year, age categories, sex and database during the study period between 2012 and 2022.
• Study status:
  Finalised

Research institution and networks

Institutions

Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, IDIAPJGol

Spain

Networks

Data Analysis and Real World Interrogation Network (DARWIN EU®)

Belgium

Croatia

Denmark

Estonia

Finland

France

Germany

Hungary

Netherlands

Norway

Portugal

Spain

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 20/06/2023

Actual: 20/06/2023

Study start date

Planned: 01/01/2012

Actual: 01/01/2023

Date of interim report, if expected

Planned: 17/11/2023

Date of final study report

Planned: 29/12/2023

Actual: 15/12/2023

Sources of funding

EMA

Study protocol

Initial protocol

Study Protocol P2 C1-005 Version 4.1 final

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable