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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


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


Minimum age: N/A. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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