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

Terminated

• Conditions: Turner's Syndrome; Growth Hormone Deficiency
• Interventions: Drug: somatropin

• Registration Number: NCT02018172
• Lead Sponsor: Ferring Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-17
• Study First Submitted QC: 2013-12-17
• Study First Posted: 2013-12-23
• Study Start: 2014-07
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-11
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Zomacton® treatment with Zomajet® Vision X device	somatropin	-

Primary Outcome Measures

Name	Time	Method
Rate of overall treatment adherence	Up to 18 months	Ratio between actual duration of administration and total duration recommended by physician

Trial Locations

Locations (1)

Hôpital des Enfants, CHU de Toulouse; 🇫🇷 Toulouse, France