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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01306357
First received: February 28, 2011
Last updated: February 6, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Turner's Syndrome
Human Growth Hormone Deficiency
Drug: Somatropin

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Overall treatment compliance [ Time Frame: up to three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 87
Study Start Date: September 2007
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Drug: Somatropin
4 mg or 10 mg delivered by needle-free device
Other Names:
  • human growth hormone
  • Zomacton

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients who meet the criteria of the Treatment Information Sheet (growth hormone deficiency or Turner's syndrome) for which treatment is initiated with Zomacton® 4 mg using the Zomajet® 2 Vision needle-free device or with Zomacton® 10 mg using the Zomajet® Vision X.

Criteria

Inclusion Criteria:

  • Growth hormone deficiency
  • Turner's syndrome

Exclusion Criteria:

  • Patients who do not meet the criteria in the treatment Information Sheet
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01306357

Locations
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, France
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01306357     History of Changes
Other Study ID Numbers: RZO 01
Study First Received: February 28, 2011
Last Updated: February 6, 2012
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by Ferring Pharmaceuticals:
Turner's syndrome
somatropin
human growth hormone deficiency

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Syndrome
Turner Syndrome
Adnexal Diseases
Bone Diseases
Bone Diseases, Developmental
Bone Diseases, Endocrine
Brain Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Central Nervous System Diseases
Chromosome Disorders
Congenital Abnormalities
Disease
Disorders of Sex Development
Dwarfism
Genetic Diseases, Inborn
Genital Diseases, Female
Gonadal Disorders
Heart Defects, Congenital
Heart Diseases
Hypopituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Ovarian Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014