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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Ferring Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02018172
First received: December 17, 2013
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Growth Hormone Deficiency
Turner's Syndrome
Drug: somatropin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Rate of overall treatment adherence [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
    Ratio between actual duration of administration and total duration recommended by physician


Estimated Enrollment: 90
Study Start Date: July 2014
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Zomacton® treatment with Zomajet® Vision X device Drug: somatropin
Other Name: Zomacton®

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with a growth hormone deficiency or Turner's syndrome.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02018172

Contacts
Contact: Clinical Development Support DK0-Disclosure@ferring.com
Contact: There may be other sites in this country

Locations
France
Hôpital des Enfants, CHU de Toulouse Recruiting
Toulouse, France
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02018172     History of Changes
Other Study ID Numbers: 000122
Study First Received: December 17, 2013
Last Updated: November 18, 2014
Health Authority: France: The Commission nationale de l’informatique et des libertés
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Additional relevant MeSH terms:
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Turner Syndrome
Dwarfism, Pituitary
Adnexal Diseases
Bone Diseases
Bone Diseases, Developmental
Bone Diseases, Endocrine
Brain Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Central Nervous System Diseases
Chromosome Disorders
Congenital Abnormalities
Disorders of Sex Development
Dwarfism
Endocrine System Diseases
Genetic Diseases, Inborn
Genital Diseases, Female
Gonadal Disorders
Heart Defects, Congenital
Heart Diseases
Hypopituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Ovarian Diseases
Pituitary Diseases
Sex Chromosome Disorders
Sex Chromosome Disorders of Sex Development

ClinicalTrials.gov processed this record on November 23, 2014