Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free Device

Turner's Syndrome Clinical Trial

— ZOMAJET  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306357
• Other study ID #: RZO 01
• Status: Completed
• Start date: September 2007
• Est. completion date: November 2011

Study information

• Verified date: February 2012
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 16 Years

Eligibility

Inclusion Criteria:

• Growth hormone deficiency

• Turner's syndrome

Exclusion Criteria:

• Patients who do not meet the criteria in the treatment Information Sheet

Related Conditions & MeSH terms

• Gonadal Dysgenesis
• Human Growth Hormone Deficiency
• Turner Syndrome
• Turner's Syndrome

Intervention

Drug:
• Somatropin
4 mg or 10 mg delivered by needle-free device

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall treatment compliance		up to three years
Secondary	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)
Secondary	Description of the Dosages of Growth Hormone and way of use of needle-free device		up to 3 years
Secondary	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
Secondary	Average Duration of Treatment		up to three years