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A Safety and Pharmacokinetic study in Real-life practice of Pylera® in France: The SAPHARY study

France, 2014 - 2016
Reference ID
FRESH-PEF73260-en
Producer(s)
Patrick Blin
Metadata
DDI/XML JSON
Created on
Nov 15, 2025
Last modified
Nov 15, 2025
Page views
4
  • Identification
  • Scope
  • Coverage
  • Producers and sponsors
  • Study authorization
  • Sampling
  • Survey instrument
  • Data collection
  • Study activities
  • Quality standards
  • Data Access
  • Contacts
  • Metadata production

    • Identification

    Survey ID number

    FRESH-PEF73260-en
    Title

    A Safety and Pharmacokinetic study in Real-life practice of Pylera® in France: The SAPHARY study
    Abbreviation or Acronym

    SAPHARY
    Country
    Name
    France
    Abstract

    The primary objective of the study is to verify the absence of accumulation of bismuth in subjects prescribed Pylera®, a pharmacokinetic approach in a real-life setting.
    Kind of Data

    ['Clinical data','Participant-reported health data','Biological data']
    Unit of Analysis

    Individuals

    Scope

    Topics
    Topic Vocabulary URI
    Gastroenterology health theme
    cim-11 http://id.who.int/icd/entity/1987089698
    Keywords
    Bismuth neurological adverse event Pylera Helicobacter Pylori infection Bordeaux PharmacoEpi Service de Pharmacologie médicale

    Coverage

    Universe

    {
    "level_sex_clusion_I": [
    "Male",
    "Female"
    ],
    "level_age_clusion_I": [
    "Young Adult (19 to 24 years)",
    "Adult (25 to 44 years)",
    "Middle Aged (45 to 64 years)",
    "Aged (65 to 79 years)",
    "Aged, 80 and over (80 years and more)"
    ],
    "level_type_clusion_I": [
    "Patients population"
    ],
    "level_type_clusion_other": "",
    "clusion_I": "",
    "clusion_E": ""
    }

    Producers and sponsors

    Primary investigators
    Name
    Patrick Blin
    Producers
    Name Role
    UNIVERSITE DE BORDEAUX sponsor
    Funding Agency/Sponsor
    Name
    ALLERGAN INDUSTRIE

    Study authorization

    Agency
    Agency name
    CNIL
    CPP
    CESREES

    Sampling

    Sample frame

    Unit Type

    ['Through independent healthcare practitioners']
    Sampling Procedure

    ['Other']

    Survey instrument

    Questionnaires

    Access on specific project only
    Methodology notes

    Observational Study

    Data collection

    Dates of Data Collection
    Start End
    2014 2016
    Time Method

    Longitudinal or cohort study
    Mode of data collection
    • Converting or copying information into a structured record

    Study activities

    Study activities
    Type
    primary evaluation
    Description
    Health event/morbidity Health event/mortality Health care consumption and services Others

    Quality standards

    Quality standards
    Standard
    ['MedDRA coding for neurological and non neurological adverse event (SOC and PT); ATC code']

    Data Access

    Availability Status

    To be defined
    Notes

    The ownership of data is defined in a Master Agreement established between the Sponsor, the University of Bordeaux and ADERA (a non-profit making association).

    Contacts

    Contacts
    Name Email
    Patrick Blin patrick.blin@u-bordeaux.fr

    Metadata production

    DDI Document ID

    FRESH-PEF73260-en
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