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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: |
NCT00262249 |
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Date of registration:
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05/12/2005 |
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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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Effect of Growth Hormone in Children With Growth Hormone Deficiency
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Scientific title:
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Effect of Growth Hormone in Children With Growth Hormone Deficiency and Idiopathic Short Stature |
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Date of first enrolment:
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August 2000 |
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Target sample size:
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173 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00262249 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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United States
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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:
- Clinically suspected GHD
- Height < -2.0 SDS
- Serum IGF-I less than or equal to -1.0 SDS
- Bone age less than or equal to 9 years for boys and less than or equal to 7 years for
girls.
- Puberty Tanner Stage I
Exclusion Criteria:
- Previous use of growth hormone
- Growth retardation attributable to causes other than GHD (e.g. inborn errors of
metabolism, primary bone disease, chromosomal disorders, etc.)
- Intrauterine growth retardation: birth weight < 3rd percentile.
- Administration of other growth-altering medications.
- Evidence of any malignancy or intracranial tumors.
Age minimum:
3 Years
Age maximum:
15 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Growth Hormone Disorder
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Idiopathic Short Stature
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Growth Hormone Deficiency in Children
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Growth Disorder
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Intervention(s)
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Drug: somatropin
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Primary Outcome(s)
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Change in height standard deviation score
[Time Frame: 24 month]
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Secondary Outcome(s)
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IGFBP-3
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free IGF-I
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IGF-I
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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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