Status: Finalised First registered on: 21/10/2011
Last updated on: 05/11/2013
1. Study identification
EU PAS Register NumberEUPAS2225
Official titleRisk of Upper Gastrointestinal Complications in Users of Nonsteroidal Anti-inflammatory Drugs
Study title acronym
Study typeObservational study
Brief description of the studyRetrospective cohort study and nested case-control analysis to evaluate the risk of upper gastrointestinal complications (UGIC ) in a cohort of patients receiving NSAIDs between 2001-2008 in the Italian region of Friuli Venezia Giulia (FVG). The study was conducted by a research team from RTI Health Solutions, the Institute of Hygiene and Clinical Epidemiology of the University of Udine and University Hospital of Udine, and the Direzione Centrale della Salute, Integrazione Socio Sanitaria e Politiche Sociali, Udine. The study was based on information from the FVG Regional Health Services Databases and hospital medical charts for the validation of cases of UGIC. The objectives of the study were to (1) estimate the risk of UGIC associated with the use of nimesulide and other individual NSAIDs, (2) evaluate the effect of dose and duration of use of individual NSAIDs and the role of potential risk factors for UGIC, and (3) describe the characteristics of nimesulide users over time.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
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 to which the investigator belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Website/Homepagewww.rtihs.org
Details of (Primary) lead investigator
Title Dr
Last name Perez-Gutthann
First name Susana
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?21

EPIDEMIOLOGY- DSMB - UDINE UNIVERSITY
Countries in which this study is being conducted
National study

Italy
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed20/10/2009
Start date of data collection15/12/200908/02/2010
Start date of data analysis01/05/201001/06/2010
Date of interim report, if expected23/03/2011
Date of final study report14/02/201101/07/2011
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesHelsinn Healthcare, S.A.100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Perez-Gutthann
First name Susana
Address line 1Trav. Gracia, 56, Atico 1
Address line 2 
Address line 3 
CityBarcelona 
Postcode08006 
CountrySpain
Phone number (incl. country code)34932417760 
Alternative phone number 
Fax number (incl. country code)34934142610 
Email address sperez@rti.org
Public Enquiries
Title Dr 
Last name Perez-Gutthann 
First name Susana 
Address line 1Trav. Gracia, 56, Atico 1 
Address line 2 
Address line 3 
CityBarcelona 
Postcode08006 
CountrySpain 
Phone number (incl. country code)34932417760 
Alternative phone number 
Fax number (incl. country code)34934142610 
Email address sperez@rti.org 
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