Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm
NCT ID: NCT00163189
Last Updated: 2024-02-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
98 participants
INTERVENTIONAL
2005-01-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Somatropin
Somatropin
Liquid, daily, during 3 years and extended to 5 years Dosage: 0,46 mg/kg/week - the maximum dose should not exceed 50 µg/kg/day
Interventions
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Somatropin
Liquid, daily, during 3 years and extended to 5 years Dosage: 0,46 mg/kg/week - the maximum dose should not exceed 50 µg/kg/day
Eligibility Criteria
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Inclusion Criteria
* Bone age \< 15 years for a boy and \< 13 years for a girl
* Child measured height \< - 2 SD, Child currently treated by GH
Exclusion Criteria
* A previous history of intolerance or hypersensitivity to the study drug or to drugs with similar chemical structures
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Hôpital Nord
Amiens, , France
Centre Hospitalier Intercommunal d'Annemasse-Bonneville, Service de Pédiatrie et Néonatologie
Annemasse, , France
Hôpital Saint Jacques
Besançon, , France
Groupe hospitalier Est- Hôpital Femme, Mère, Enfant
Bron, , France
Groupe hospitalier Est-Hôpital Femme, Mère, Enfant
Bron, , France
CHU d'Estaing
Clermont-Ferrand, , France
CHU de Grenoble, Hôpital Couple enfant.
Grenoble, , France
CHU Timone Enfants
Marseille, , France
Hôpital Arnaud De Villeneuve
Montpellier, , France
CHU de Nantes, Hôpital Mère Enfant
Nantes, , France
Hôpital Lenval
Nice, , France
Hôpital Robert Debré
Paris, , France
Hôpital Armand Trousseau
Paris, , France
Groupe Hospitalier Necker - Enfants Malades
Paris, , France
Centre de Perharidy
Roscoff, , France
CHU Charles Nicolle
Rouen, , France
Service de Pédiatrie- Centre Hospitalier Intercommunal
Saint-Germain-en-Laye, , France
Hôpital des Enfants
Toulouse, , France
CHU Tours - Centre Pediatrique Gatien de Cocheville
Tours, , France
Countries
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References
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Basmaison O, Ranchin B, Zouater H, Robertson A, Gomez R, Koppiker N. Efficacy and safety of recombinant growth hormone treatment in children with growth retardation related to long-term glucocorticosteroid therapy. Ann Endocrinol (Paris). 2019 Sep;80(4):202-210. doi: 10.1016/j.ando.2019.02.001. Epub 2019 Mar 4.
Related Links
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Other Identifiers
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2004-002992-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A6281271
Identifier Type: -
Identifier Source: org_study_id
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