Overview

Evaluation of the Adherence and the Patient Acceptability of Zomacton® Treatment With the Zomajet® Vision X Device

Status:
Terminated
Trial end date:
2015-02-01
Target enrollment:
0
Participant gender:
All
Summary
The 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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ferring Pharmaceuticals
Criteria
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