Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free Device
ZOMAJET
Evaluation De L'Observance Globale Et De La Duree De Traitement Par Zomacton® Avec Le Stylo Transjecteur Zomajet® Etude Pharmaco-Epidemiologique Observationnelle Longitudinale Prospective
1 other identifier
observational
87
1 country
17
Brief Summary
The purpose of this strictly observational, prospective, longitudinal study is to evaluate with sufficient precision the rate of overall treatment compliance from one year to 3 years of follow-up of the patients. Somatotropin is indicated in the long-term treatment of children with growth retardation related to a deficiency in secretion of growth hormone and in the long-term treatment of growth retardation related to Turner's syndrome confirmed by chromosomal analysis. These are the two indications of Zomacton® 4 mg and 10 mg injection solution. The use of the Zomajet® needle-free device (Zomajet® 2 Vision, reserved for the administration of Zomacton® 4 mg or of the Zomajet® Vision X needle-free device, reserved for the administration of Zomacton® 10 mg), allows the product to be administered by percutaneous transjection (needle-free) and can be used by the child directly or by the family after an initial training. In April 2004, the CEPP (Commission for the Evaluation of Products and Services) requested a follow-up of the cohort of patients using the Zomajet® 2 Vision system measuring the compliance and duration of use of the device. The number of patients initiated on Zomacton treatment using the Zomajet® needle-free device is estimated to 30. Over a period of inclusion of 3 years, we therefore estimate that 90 patients will be treated. In the cohort studied the patients will be followed-up for 1 year at least and for 3 years at the maximum. The rate of treatment compliance will be evaluated according to the ratio of the actual duration of administration over the total duration recommended by the physician during the observation period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2007
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 28, 2011
CompletedFirst Posted
Study publicly available on registry
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedNovember 18, 2023
February 1, 2012
4.1 years
February 28, 2011
November 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall treatment compliance
up to three years
Secondary Outcomes (4)
Description of the auxological and biochemical characteristics of the population at inclusion (notably the exploration of GH deficiency, the height, the difference in height from the average in SD, the rate of growth prior to treatment)
Baseline (day 0)
Description of the Dosages of Growth Hormone and way of use of needle-free device
up to 3 years
Description of the evolution of the auxological and biochemical parameters (gain in height in SD, growth rate, IGF-1 if available)
Baseline (Day 0), up to three years
Average Duration of Treatment
up to three years
Study Arms (1)
Zomacton® with Zomajet® needle-free device
Zomacton® 4 mg delivered by percutaneous transjection (needle-free) using the Zomajet® 2 Vision device or Zomacton® 10 mg delivered by percutaneous transjection (needle-free) using the Zomajet® Vision X needle-free device.
Interventions
4 mg or 10 mg delivered by needle-free device
Eligibility Criteria
All patients who meet the criteria of the Treatment Information Sheet (growth hormone deficiency or Turner's syndrome) for which treatment is initiated with Zomacton® 4 mg using the Zomajet® 2 Vision needle-free device or with Zomacton® 10 mg using the Zomajet® Vision X.
You may qualify if:
- Growth hormone deficiency
- Turner's syndrome
You may not qualify if:
- Patients who do not meet the criteria in the treatment Information Sheet
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Investigational site
Angers, France
Investigational site
Bordeaux, France
Investigational site
Brive-la-Gaillarde, France
Investigational site
Hyères, France
Investigational site
Juan-les-Pins, France
Investigational site
Le Mans, France
Investigational site
Lille, France
Investigational site
Lisieux, France
Investigational site
Montivilliers, France
Investigational site
Montpellier, France
Investigational site
Nice, France
Investigational site
Nieul-sur-Mer, France
Investigational site
Paris, France
Investigational site
Puyricard, France
Investigational site
Tarbes, France
Investigational site
Toulon, France
Investigational site
Toulouse, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2011
First Posted
March 1, 2011
Study Start
September 1, 2007
Primary Completion
October 1, 2011
Study Completion
November 1, 2011
Last Updated
November 18, 2023
Record last verified: 2012-02