Growth Hormone Deficiency Clinical Trial
— ZOMAXEPTThe study is performed to collect long-term data on the treatment adherence and patient's acceptability when Zomacton®10 mg is administered with the Zomajet® Vision X device in patients with a growth hormone deficiency or Turner's syndrome.
Status | Terminated |
Enrollment | 3 |
Est. completion date | February 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patient with growth hormone deficiency, 1. Diagnosis of growth hormone deficiency proven by appropriate exploration 2. Size = -2 Standard Deviation (SD) according to the French references 3. Growth velocity in the previous year inferior to the normal for age (-1SD) or < 4cm/year - Growth deficiency due to Turner's syndrome 1. Turner's syndrome confirmed by a karyotype 2. Patient's size = -2 SD according to the French references 3. Bone age < 12 years - Patient who require a minimum of 18 months of treatment. Exclusion Criteria: - There are no exclusion criteria except the contraindication for Zomacton® 10 mg |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | Hôpital des Enfants, CHU de Toulouse | Toulouse |
Lead Sponsor | Collaborator |
---|---|
Ferring Pharmaceuticals |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of overall treatment adherence | Ratio between actual duration of administration and total duration recommended by physician | Up to 18 months | No |
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