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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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16 December 2017 |
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Main ID: |
NCT00960128 |
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Date of registration:
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13/08/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Observational Prospective Study on Patients Treated With Norditropin®
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Scientific title:
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NordiNet® International Outcome Study-Observational Prospective Study on Patients Treated With Norditropin® |
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Date of first enrolment:
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April 1, 2006 |
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Target sample size:
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21249 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00960128 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Argentina
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Belgium
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Brazil
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Czech Republic
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Czechia
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Denmark
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Finland
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Former Serbia and Montenegro
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France
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Germany
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Hungary
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Ireland
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Israel
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Italy
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Lithuania
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Luxembourg
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Netherlands
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Norway
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Russian Federation
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Saudi Arabia
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Serbia
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Slovenia
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Spain
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Sweden
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Switzerland
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United Kingdom
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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:
- Judged by the physician as per the Norditropin® label
Exclusion Criteria:
- Judged by the physician as per the Norditropin® label
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Genetic Disorder
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Growth Hormone Deficiency in Children
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Turner Syndrome
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Chronic Renal Insufficiency
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Growth Hormone Disorder
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Adult Growth Hormone Deficiency
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Chronic Kidney Disease
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Foetal Growth Problem
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Noonan Syndrome
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Small for Gestational Age
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Intervention(s)
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Drug: somatropin
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Primary Outcome(s)
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Effect of Norditropin® treatment on body weight and body composition in adults
[Time Frame: Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study.]
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Effect of Norditropin® treatment on height gain (change in height) in children
[Time Frame: Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study.]
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Secondary Outcome(s)
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Effect of Norditropin® treatment body weight, blood biochemistry, bone age, the endocrine system and pubertal development in children
[Time Frame: Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study.]
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Effect of Norditropin® treatment on quality of life, blood biochemistry and the endocrine system in adults
[Time Frame: Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study.]
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Secondary ID(s)
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2008-001674-32
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GHLIQUID-3676
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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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