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

Ongoing
Research institution and networks

Institutions

Networks

Contact details

Katia Verhamme

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
EMA
Study protocol
Initial protocol

Study Protocol P2 C1-005 Version 4.1 final

English (870.37 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable