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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02018172
Recruitment Status : Terminated (Terminated due to lack of recruitment and difficulty in the selection of sites)
First Posted : December 23, 2013
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment
Growth Hormone Deficiency Turner's Syndrome Drug: somatropin

Study Design
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Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : July 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Turner Syndrome

Groups and Cohorts
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Group/Cohort Intervention/treatment
Zomacton® treatment with Zomajet® Vision X device Drug: somatropin
Other Name: Zomacton®


Outcome Measures
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Primary Outcome Measures :
  1. Rate of overall treatment adherence [ Time Frame: Up to 18 months ]
    Ratio between actual duration of administration and total duration recommended by physician


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02018172


Locations
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France
Hôpital des Enfants, CHU de Toulouse
Toulouse, France
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
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Study Director: Clinical Development Support Ferring Pharmaceuticals
More Information
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Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02018172    
Other Study ID Numbers: 000122
First Posted: December 23, 2013    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Turner Syndrome
Gonadal Dysgenesis
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
 Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases