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

Ferring

Status: Terminated

Conditions: Turner's Syndrome; Growth Hormone Deficiency

Treatments: Drug: somatropin

Study type: Observational

Funder types: Industry

Identifiers

NCT02018172

000122

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

3 participants in 1 patient group

Zomacton® treatment with Zomajet® Vision X device

Treatment:

Drug: somatropin