Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free Device
Information source: Ferring Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Turner's Syndrome; Human Growth Hormone Deficiency
Intervention: Somatropin (Drug)
Phase: N/A
Status: Completed
Sponsored by: Ferring Pharmaceuticals Official(s) and/or principal investigator(s): Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals
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.
Clinical Details
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
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Overall treatment compliance
Secondary outcome: 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)Description of the Dosages of Growth Hormone and way of use of needle-free device Description of the evolution of the auxological and biochemical parameters (gain in height in SD, growth rate, IGF-1 if available) Average Duration of Treatment
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Growth hormone deficiency
- Turner's syndrome
Exclusion Criteria:
- Patients who do not meet the criteria in the treatment Information Sheet
Locations and Contacts
Investigational site, Angers, France
Investigational site, Antibes Juan Les Pins, France
Investigational site, Bordeaux, France
Investigational site, Brive La Gaillarde, France
Investigational site, Hyeres, 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
Additional Information
Starting date: September 2007
Last updated: February 6, 2012
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