Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free Device
NCT ID: NCT01306357
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
87 participants
OBSERVATIONAL
2007-09-30
2011-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
Somatropin
4 mg or 10 mg delivered by needle-free device
Interventions
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Somatropin
4 mg or 10 mg delivered by needle-free device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Turner's syndrome
Exclusion Criteria
1 Year
16 Years
ALL
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Investigational site
Angers, , France
Investigational site
Antibes Juan Les Pins, , France
Investigational site
Bordeaux, , France
Investigational site
Brive-la-Gaillarde, , France
Investigational site
Hyères, , 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
Countries
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Other Identifiers
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RZO 01
Identifier Type: -
Identifier Source: org_study_id
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