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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01327924 |
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Date of registration:
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31/03/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Usability and Tolerability of the Norditropin NordiFlex® Injection Device in Children Never Previously Treated With Growth Hormone
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Scientific title:
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Ease of Use and Tolerability of Norditropin NordiFlex® in Growth Hormone naïve Children: Impact on Daily Life |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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77 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01327924 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Global Clinical Registry (GCR, 1452) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novo Nordisk A/S |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Growth hormone (GH) treatment naïve subjects for whom it has been decided to initiate
GH treatment prior to enrollment into the study
- Subjects who receive Norditropin NordiFlex® according to the SPC
Exclusion Criteria:
- Known or suspected allergy to study product(s) or related products
- Child and/or parent unable to give consent or fill out the questionnaires
- The receipt of any investigational medicinal product within 3 months prior to this
study
- Suffer from a life-threatening disease
Age minimum:
N/A
Age maximum:
16 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Kidney Disease
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Chronic Renal Insufficiency
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Foetal Growth Problem
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Turner Syndrome
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Small for Gestational Age
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Delivery Systems
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Growth Hormone Deficiency in Children
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Genetic Disorder
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Growth Hormone Disorder
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Intervention(s)
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Drug: Norditropin NordiFlex®
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Primary Outcome(s)
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Usability of growth hormone injection device assessed by a quantitative scale
[Time Frame: after 3 months of growth hormone treatment]
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Secondary Outcome(s)
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Number of technical complaints
[Time Frame: from 0 to 3 months of growth hormone treatment]
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Number of adverse events
[Time Frame: from 0 - 3 months of growth hormone treatment]
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Secondary ID(s)
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U1111-1119-8619
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GH-3870
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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