Status: FinalisedLast updated on: 13/07/2017
1. Study identification
EU PAS Register NumberEUPAS3901
Official titleDrug usage patterns of Pylera® in France using the national claims reimbursement database
Study title acronymDUS
Study typeOther: Study using claims database
Brief description of the studyThe objective of the study is to describe the usage patterns of Pylera® in real-life practice. All subjects in the EGB database with one or more claims of Pylera® from April 2013 to March 2015 will be included in the study. A reference population will be defined using patients with a dispensation of specific tritherapy to eradicate H. pylori and the same design. Several cohorts will be identified from Pylera® post-launch, each representing an increment of the number of patients including in the preceding cohort, as well as of the follow-up duration. Consequently, each successive and incremental cohort will be described using information available at the time of data extraction. The index date is defined as the date of the first dispensation of Pylera® (Pylera® population) and as the date of the first dispensation of specific tritherapy to eradicate H. pylori (Reference population). Patients will be included for a period of 2 years and analysed after one month of follow-up (description at inclusion), after 3 months of follow-up (misuse), after one year of follow-up (treatment failure), and after 2 years of follow-up (recurrence). The evaluation criteria will be defined as: - Number of drug packs dispensed per patient and per year - Misuse: dispensation of more than one pack of Pylera® at index date or a dispensation of Pylera® not preceded by urea breath test (UBT) or endoscopy (within the year before first dispensation) - Normal use: patient without misuse at index date - Treatment failure: dispensation of a second pack of Pylera® or of another H. pylori eradication drug combination after or not UBT or endoscopy in the 12 months following first dispensation of Pylera® - Treatment of recurrent infection: dispensation of a new pack of Pylera® or of another drug combination for H. pylori eradication after or not UBT or endoscopy 12 months or more after the last dispensation of Pylera®.
Was this study requested by a regulator?Yes: France, Germany
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBordeaux PharmacoEpi
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
Website/Homepagewww.pharmacoepi.eu
Details of (Primary) lead investigator
Title Professor
Last name Moore
First name Nicholas
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed21/06/2012
Start date of data collection09/10/2013
Start date of data analysis
Date of interim report, if expected30/06/201628/06/2016
Date of final study report31/05/201709/06/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAptalis Pharma100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Blin
First name Patrick
Address line 1Université Bordeaux Segalen
Address line 2Bâtiment du Tondu - Case 41 
Address line 3146 Rue Leo Saignat 
CityBordeaux 
Postcode33076 
CountryFrance
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code)33557574740 
Public Enquiries
Title Dr 
Last name Blin 
First name Patrick 
Address line 1Université Bordeaux Segalen 
Address line 2Bâtiment du Tondu - Case 41 
Address line 3146 Rue Leo Saignat 
CityBordeaux 
Postcode33076 
CountryFrance 
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code)33557574740 
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