Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free Device
Status:
Completed
Trial end date:
2011-11-01
Target enrollment:
Participant gender:
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.