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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 May 2015
• Main ID: NCT02018172
• Date of registration: 17/12/2013
• Prospective Registration: Yes
• Primary sponsor: Ferring Pharmaceuticals
• Public title: Evaluation of the Adherence and the Patient Acceptability of Zomacton® Treatment With the Zomajet® Vision X Device ZOMAXEPT
• Date of first enrolment: July 2014
• Target sample size: 3
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT02018172
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Clinical Development Support
• Affiliation: Ferring Pharmaceuticals

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Growth Hormone Deficiency

Turner's Syndrome

Intervention(s)

Drug: somatropin

Primary Outcome(s)

Rate of overall treatment adherence [Time Frame: Up to 18 months]

Secondary ID(s)

000122

Source(s) of Monetary Support

Please refer to primary and secondary sponsors