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

Ferring Pharmaceuticals1 site in 1 country3 target enrollmentJuly 2014

ConditionsGrowth Hormone Deficiency Turner's Syndrome

Interventionssomatropin

Drugssomatropin

Overview

Phase: Not Applicable
Intervention: somatropin
Conditions: Growth Hormone Deficiency
Sponsor: Ferring Pharmaceuticals
Enrollment: 3
Locations: 1
Primary Endpoint: Rate of overall treatment adherence
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 2014

End Date

February 2015

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Ferring Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient with growth hormone deficiency,
•Diagnosis of growth hormone deficiency proven by appropriate exploration
•Size ≤ -2 Standard Deviation (SD) according to the French references
•Growth velocity in the previous year inferior to the normal for age (-1SD) or \< 4cm/year
•Growth deficiency due to Turner's syndrome
•Turner's syndrome confirmed by a karyotype
•Patient's size ≤ -2 SD according to the French references
•Bone age \< 12 years
•Patient who require a minimum of 18 months of treatment.