Status: Ongoing First registered on: 16/10/2023
Last updated on: 23/10/2023
1. Study identification
EU PAS Register NumberEUPAS106798
Official titleDARWIN EU® CC - Drug utilisation study of medicines with prokinetic properties in children and adults diagnosed with gastroparesis
Study title acronym
Study typeObservational study
Brief description of the studyGastroparesis 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.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameDARWIN EU® CC
Centre locationRotterdam, Netherlands
Details of (Primary) lead investigator
Title Dr
Last name Verhamme
First name Katia
Is this study being carried out with the collaboration of a research network?
Yes

DARWIN EU CC
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?7

IDIAPJGol
Clinical Data Warehouse of Bordeaux University Hospital (CHUBX), France
Clinical Practice Research Datalink GOLD (CPRD GOLD), United Kingdom
IQVIA DA Germany, Germany
IQVIA LPD Belgium, Belgium
Institut Municipal Assistencia Sanitaria Information System (IMASIS), Spain
Integrated Primary Care Information Project (IPCI), Netherlands
Countries in which this study is being conducted
International study

Belgium
France
Germany
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed20/06/202320/06/2023
Start date of data collection01/01/201201/01/2023
Start date of data analysis
Date of interim report, if expected17/11/2023
Date of final study report29/12/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyEMA100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Verhamme
First name Katia
Address line 1Dr. Molewaterplein 40
Address line 2 
Address line 3 
CityRotterdam 
Postcode 
CountryNetherlands
Phone number (incl. country code)31107043050 
Alternative phone number 
Fax number (incl. country code) 
Email address study@darwin-eu.org
Public Enquiries
Title Mrs 
Last name Schuemie 
First name Ilse 
Address line 1Dr. Molewaterplein 40 
Address line 2 
Address line 3 
CityRotterdam 
Postcode 
CountryNetherlands 
Phone number (incl. country code)31107043050 
Alternative phone number 
Fax number (incl. country code) 
Email address study@darwin-eu.org 
Top