Optimization of the Dosage Regimen of Growth Hormone Therapy in Children Born Small for Gestational Age
NCT ID: NCT00249821
Last Updated: 2017-09-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
22 participants
INTERVENTIONAL
2005-02-28
2007-09-30
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
Study Groups
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Saizen® 0.057 mg/kg/day
Subjects who met all inclusion/exclusion criteria were randomly assigned to 0.057 mg/kg/day in this multi-center study. Subjects were stratified at randomization according to the Height-Standard Deviation Score (H-SDS) at this time (less than \[\<\] -2 SDS or greater than \[\>\] -2 SDS)
Saizen®
Saizen® \[somatropin (recombinant deoxyribonucleic acid \[rDNA\] origin) for injection\], a r-hGH, is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.
Saizen® 0.035 mg/kg/day
Subjects who met all inclusion/exclusion criteria were randomly assigned to 0.035 mg/kg/day in this multi-center study. Subjects were stratified at randomization according to the H-SDS at this time (\< -2 SDS or \> -2 SDS)
Saizen®
Saizen® \[somatropin (rDNA origin) for injection\], a r-hGH, is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.
Interventions
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Saizen®
Saizen® \[somatropin (recombinant deoxyribonucleic acid \[rDNA\] origin) for injection\], a r-hGH, is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.
Saizen®
Saizen® \[somatropin (rDNA origin) for injection\], a r-hGH, is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject born SGA and receiving a r-hGH therapy for this pathology
* Recombinant human growth hormone (r-hGH) started at the maximal chronological age of 7 years for girls and 8 years for boys
* Treatment with r-hGH started for at least 30 months and less than 36 months at 0.057 mg/kg/day
* Height gain during the first 2 years of GH treatment \> 1 SD compared with the initial value
Exclusion Criteria
* Known hypersensitivity to Somatropin or any of the excipients
* Active neoplasia (either newly diagnosed or recurrent)
* Intracranial hypertension
* Known diabetes mellitus
* Proliferative or preproliferative diabetic retinopathy
* Evidence of any progression or recurrence of an underlying intra-cranial space occupying lesion
* Obesity defined as degree 1 on the corpulence curves
* Precocious puberty
* Pubertal status: Tanner breast development stage \> 2 for girls, and testicular volume \> 4 milliliter (mL) or testicular length \> 3 centimeter (cm) and/or testosterone value \>1 nanomole/liter \[nmol/L\] (0.29 gram/mL \[g/mL\]) for boys For girls \> 9 years and Tanner breast development stage 1: uterine size \> 35 millimeter (mm)
* Severe chronic concomitant illness such as chronic renal failure, cystic fibrosis
* Concomitant corticoid treatment or levothyroxine treatment other than substitutive treatment, topical or inhaled treatment
* Participation to any clinical study within the 30 days preceding study entry
6 Years
11 Years
ALL
No
Sponsors
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Merck Serono S.A.S., an affiliate of Merck KGaA, Darmstadt, Germany
UNKNOWN
Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck Serono S.A.S, France
References
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Chatelain P, Colle M, Nako JP, Le Luyer B, Wagner K, Berlier P, Tauber M. Optimization of growth hormone dosing in children born small for gestational age: an open-label, randomized study of children during the fourth year of therapy. Horm Res Paediatr. 2012;77(3):156-63. doi: 10.1159/000337216. Epub 2012 Apr 12.
Related Links
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Other Identifiers
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IMP 25735
Identifier Type: -
Identifier Source: org_study_id