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

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ClinicalTrials.gov Identifier: NCT01306357
Recruitment Status : Completed
First Posted : March 1, 2011
Last Update Posted : February 7, 2012
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment
Turner's Syndrome Human Growth Hormone Deficiency Drug: Somatropin

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Study Type : Observational
Actual Enrollment : 87 participants
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
Study Start Date : September 2007
Actual Primary Completion Date : October 2011
Actual Study Completion Date : November 2011

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Overall treatment compliance [ Time Frame: up to three years ]

Secondary Outcome Measures :
  1. 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) ]
  2. Description of the Dosages of Growth Hormone and way of use of needle-free device [ Time Frame: up to 3 years ]
  3. 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 ]
  4. Average Duration of Treatment [ Time Frame: up to three years ]

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

Inclusion Criteria:

  • Growth hormone deficiency
  • Turner's syndrome

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01306357

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Investigational site
Angers, France
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Antibes Juan Les Pins, France
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Bordeaux, France
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Brive La Gaillarde, France
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Hyeres, France
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Le Mans, France
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Lille, France
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Lisieux, France
Investigational site
Montivilliers, France
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Montpellier, France
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Nice, France
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Nieul Sur Mer, France
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Paris, France
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Puyricard, France
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Tarbes, France
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Toulon, France
Investigational site
Toulouse, France
Sponsors and Collaborators
Ferring Pharmaceuticals
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Study Director: Clinical Development Support Ferring Pharmaceuticals
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Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01306357    
Other Study ID Numbers: RZO 01
First Posted: March 1, 2011    Key Record Dates
Last Update Posted: February 7, 2012
Last Verified: February 2012
Keywords provided by Ferring Pharmaceuticals:
Turner's syndrome
human growth hormone deficiency
Additional relevant MeSH terms:
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Turner Syndrome
Gonadal Dysgenesis
Endocrine System Diseases
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Gonadal Disorders
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs