ZOMAJET - Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free Device (ZOMAJET)

Head :
Bahbah Farah

Last update : 07/30/2015 | Version : 2 | ID : 2526

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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
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General
Identification
Detailed name Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free Device (ZOMAJET)
Sign or acronym ZOMAJET
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation 907122 (CNIL)
General Aspects
Medical area Endocrinology and metabolism
Keywords Somatropin, zomacton, zomajet vision X, Zomajet 2 vision
Scientific investigator(s) (Contact)
Name of the director Bahbah
Surname Farah
Address Laboratoire Ferring SAS. 7 Rue jean-baptiste clement. 94250 Gentilly
Email Farah.Bahbah@ferring.com
Organization FERRING
Collaborations
Funding
Funding status Private
Details Laboratory Ferring SAS
Governance of the database
Sponsor(s) or organisation(s) responsible Laboratoire FERRING SAS
Organisation status Private
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Longitudinal study (except cohorts)
Database recruitment is carried out by an intermediary A selection of health institutions and services
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. All patients, meeting the criteria of the Therapeutic Information Sheet (growth hormone deficiency or Turner's syndrome), for whom is initiated a treatment with Zomacton® 4 mg with the Zomajet® 2 Vision transjector or with Zomacton® 10 mg with the Zomajet® Vision X transjector when the latter has received its marketing authorization.
Database objective
Main objective Evaluate with sufficient precision the overall observance rate for the treatment over a maximum period of three years.

The study is carried out at the request of the authorities.
Inclusion criteria All patients, meeting the criteria of the Therapeutic Information Sheet (growth hormone deficiency or Turner's syndrome), for whom is initiated a treatment with Zomacton® 4 mg with the Zomajet® 2 Vision transjector or with Zomacton® 10 mg with the Zomajet® Vision X transjector when the latter has received its marketing authorization.
Population type
Age Early childhood (2 to 5 years)
Childhood (6 to 13 years)
Adolescence (13 to 18 years)
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) 2007
Date of last collection (YYYY or MM/YYYY) 2011
Size of the database
Size of the database (number of individuals) < 500 individuals
Details of the number of individuals 90
Data
Database activity Data collection completed
Type of data collected Clinical data
Declarative data
Paraclinical data
Biological data
Clinical data (detail) Direct physical measures
Declarative data (detail) Face to face interview
Paraclinical data (detail) Auxological parameters (gain in size, etc.)
Biological data (detail) IGF-1 if available
Presence of a biobank No
Health parameters studied Health event/morbidity
Health care consumption and services
Care consumption (detail) Medicines consumption
Procedures
Data collection method Questionnaire at the initiation of the treatment (initiation visit): Identification of the questionnaire; visit date; inclusion criterion (Initial Therapeutic Information Sheet); patient data: sex, date of birth, height, weight, bone age (according to the Greulich-Pyle atlas), gain in size before treatment, pubertal stage (according to Tanner), antecedents; indication (deficit in GH or Turner's syndrome with karyotope), cause of the deficit in GH, exploration of the deficit in GH (IGF-1 if available, stimulation tests and results, associated hormonal or endocrine disruptions); Prescribed treatment; Dosage and methods of administration.Follow-up questionnaires (1 follow-up visit about every 3 to 6 months): Identification of the questionnaire; date of visit; height, weight, bone age, pubertal stage, fasting glucose and IGF-1 (if available); Treatment administered as prescribed (yes/no) - if not, treatment administered by intermittence, stopping of the treatment and reason(s) for noncompliance; Treatment stopped by the physician (yes/no) - if yes, date and reason(s) - if not, technical difficulties in using the pen (yes/no); modification in the methods of administration (yes/no): new dosage and/or new posology and/or new head for the transjector pen and reason(s). Local and general tolerance.
Participant monitoring Yes
Details on monitoring of participants minimum 1 year and 4 years total
Links to administrative sources No
Promotion and access
Promotion
Access
Terms of data access (charter for data provision, format of data, availability delay) Clinical Report.
For further information on the ZOMAJET study, please contact: Dr Philippe NIEZ
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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