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