Growth Hormone Treatment of Children Born With Retarded Intrauterine Growth at Age 2-5 Years
NCT ID: NCT00184691
Last Updated: 2017-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
78 participants
INTERVENTIONAL
1999-04-30
2005-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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somatropin
Eligibility Criteria
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Inclusion Criteria
* Chronological age = 2-5 years
* HV below average for CA
* Insufficient catch-up growth (Height \< P3 for chronological age, according to Hernández)
* Parental height greater than or equal to -2 SDS of average, that is, 160 cm or more for the father and 148 cm or more for the mother
* Normal response to GH stimulation test (greater tan or equal to 10 ng/mL)
* Bone age (measured through Greulich and Pyle method) less than or equal to CA
Exclusion Criteria
* Children with post-ischemic encephalopathy
* Recorded malformative syndromes associated to short stature (Silver-Russell, Rubinstein Taybi, Seckel etc.)
* Any metabolic or endocrinological disorder (diabetes mellitus, diabetes insipidus, congenital metabolic disorders, with the exception of thyroid diseases corrected by replacement therapy)
* Any type of growth retardation associated to infections, embryopathies or severe chronic diseases (hemopathies, hepatopathies, malabsorptive pathology, neurologic alterations....)
* Nutritional disorders (celiac disease) or osteodystrophies
* Patients who receive or received any treatment (anabolic drugs, sex steroids, etc.) likely to interfere with GH effects
* Abnormal karyotype
* Neoplasms
* Previous or ongoing chemotherapy and/or irradiation
* Renal dysfunction, defined as serum creatinine \> 1 mg/dL
2 Years
5 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Barakaldo, , Spain
Novo Nordisk Investigational Site
Barcelona, , Spain
Novo Nordisk Investigational Site
Cadiz, , Spain
Novo Nordisk Investigational Site
Córdoba, , Spain
Novo Nordisk Investigational Site
El Palmar, , Spain
Novo Nordisk Investigational Site
Esplugues Llobregat, , Spain
Novo Nordisk Investigational Site
Granada, , Spain
Novo Nordisk Investigational Site
Madrid, , Spain
Novo Nordisk Investigational Site
Madrid, , Spain
Novo Nordisk Investigational Site
Málaga, , Spain
Novo Nordisk Investigational Site
Santa Cruz de Tenerife, , Spain
Novo Nordisk Investigational Site
Santiago de Compostela, , Spain
Novo Nordisk Investigational Site
Seville, , Spain
Countries
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References
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Argente J, Gracia R, Ibanez L, Oliver A, Borrajo E, Vela A, Lopez-Siguero JP, Moreno ML, Rodriguez-Hierro F; Spanish SGA Working Group. Improvement in growth after two years of growth hormone therapy in very young children born small for gestational age and without spontaneous catch-up growth: results of a multicenter, controlled, randomized, open clinical trial. J Clin Endocrinol Metab. 2007 Aug;92(8):3095-101. doi: 10.1210/jc.2007-0078. Epub 2007 May 29.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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GHRETARD-1106
Identifier Type: -
Identifier Source: org_study_id
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