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

Growth Hormone Deficiency Clinical Trial

— ZOMAXEPT  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02018172
• Other study ID #: 000122
• Status: Terminated
• Phase: N/A
• First received: December 17, 2013
• Last updated: May 11, 2015
• Start date: July 2014
• Est. completion date: February 2015

Study information

• Verified date: May 2015
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertésFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Gonadal Dysgenesis
• Growth Hormone Deficiency
• Primary Ovarian Insufficiency
• Turner Syndrome
• Turner's Syndrome

Intervention

Drug:
• somatropin

Locations

Country	Name	City	State
France	Hôpital des Enfants, CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

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