Drug usage patterns of Pylera® in France using the national claims reimbursement database (DUS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50218
• EU PAS number:
  EUPAS3901
• Study ID:
  50218
• Official title and acronym:
  Drug usage patterns of Pylera® in France using the national claims reimbursement database (DUS)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  The 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®.
• Study status:
  Finalised

Research institutions and networks

Institutions

Bordeaux PharmacoEpi, University of Bordeaux

France

Study timelines

Date when funding contract was signed

Actual: 21/06/2012

Study start date

Actual: 09/10/2013

Date of interim report, if expected

Planned: 30/06/2016

Actual: 28/06/2016

Date of final study report

Planned: 31/05/2017

Actual: 09/06/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Aptalis Pharma

Study protocol

Initial protocol

PYLERA-DUS Protocol-V3 1-20130502 clean

Updated protocol

PYLERA-DUS Protocol-V6.0 (signed)-20160211 vf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)
• Regulatory procedure number:
  DE/H/2467/001/DC