Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free Device (ZOMAJET)
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Evaluation De L'Observance Globale Et De La Duree De Traitement Par Zomacton® Avec Le Stylo Transjecteur Zomajet® Etude Pharmaco-Epidemiologique Observationnelle Longitudinale Prospective|
- Overall treatment compliance [ Time Frame: up to three years ] [ Designated as safety issue: No ]
- 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) [ Time Frame: Baseline (day 0) ] [ Designated as safety issue: No ]
- Description of the Dosages of Growth Hormone and way of use of needle-free device [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
- Description of the evolution of the auxological and biochemical parameters (gain in height in SD, growth rate, IGF-1 if available) [ Time Frame: Baseline (Day 0), up to three years ] [ Designated as safety issue: No ]
- Average Duration of Treatment [ Time Frame: up to three years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Study Completion Date:||November 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
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.
4 mg or 10 mg delivered by needle-free device
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306357
|Antibes Juan Les Pins, France|
|Brive La Gaillarde, France|
|Le Mans, France|
|Nieul Sur Mer, France|
|Study Director:||Clinical Development Support||Ferring Pharmaceuticals|