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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02018172

Acronym

ZOMAXEPT

Enrollment

Registered

2013-12-23

Start date

2014-07-31

Completion date

2015-02-28

Last updated

2015-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Hormone Deficiency, Turner's Syndrome

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.

Interventions

DRUGsomatropin

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026