B030 - Observational study: Conditions of use of duloxetine in France ARCHIVE

Head :
Laboratoire , Eli Lilly France

Last update : 01/01/2020 | Version : 1 | ID : 80

print
Print
xml
XML

Export to XML

Please choose the format :

pdf
PDF
xml
CSV (Excel)

Export to CSV

What sections do you want to export ?

Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
Select all | Invert selection | No selection

Which version do you want to export ?

send
Send
General
Identification
Detailed name Observational study: Conditions of use of duloxetine in France
Sign or acronym B030
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CNIL N°909021
General Aspects
Medical area Psychology and psychiatry
Others (details) Depression
Keywords Pharmacy, appropriate use, duloxetine, conditions of use
Scientific investigator(s) (Contact)
Name of the director Laboratoire
Email fr_mail_pharmacoepi@lilly.com
Unit Eli Lilly France
Collaborations
Funding
Funding status Private
Details Eli Lilly and Company
Governance of the database
Sponsor(s) or organisation(s) responsible Eli Lilly
Organisation status Private
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Not-repeated cross-sectional studies (except case control studies)
Database recruitment is carried out by an intermediary A population file
Database recruitment is is made on the basis of: Medication(s) taken
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. Patients recruited by pharmacies. Random selection of pharmacies using professional listing. Stratification by region and by zone (urban/town).
Database objective
Main objective Primary objective: evaluate the conditions for use of duloxetine in routine practice;
Secondary objectives: characteristics of the patients treated by duloxetine, profiles of duloxetine prescribers, characteristics of treatment.
Inclusion criteria Patient receiving duloxetine in a pharmacy regardless of the indication, whether treatment initiation or renewal
Population type
Age Adulthood (19 to 24 years)
Adulthood (25 to 44 years)
Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Great age (80 years and more)
Population covered Sick population
Gender Male
Woman
Geography area National
Detail of the geography area National
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2009
Date of last collection (YYYY or MM/YYYY) 2010
Size of the database
Size of the database (number of individuals) < 500 individuals
Details of the number of individuals 294
Data
Database activity Data collection completed
Type of data collected Clinical data
Clinical data (detail) Direct physical measures
Presence of a biobank No
Health parameters studied Health event/morbidity
Procedures
Data collection method Study data collection form
Participant monitoring No
Links to administrative sources No
Promotion and access
Promotion
Access
Terms of data access (charter for data provision, format of data, availability delay) Report and publications
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

Partners - FAQ - Contact - Site map - Legal notices - Administration - Updated on December 15 2020 - Version 4.10.05