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Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00163189
First received: September 9, 2005
Last updated: February 9, 2015
Last verified: February 2015
  Purpose

To estimate the evolution of height and growth rate over 5 years of growth hormone (GH) treatment To estimate the prognostic factors of growth rate with GH treatment To confirm the good clinical and biological safety of GH treatment in such children


Condition Intervention Phase
Growth Hormone Deficiency
Drug: Somatropin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evolution Of Growth Rate In Children With Growth Retardation Related To Long-term Corticotherapy And Treated By Genotonorm

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Difference between height in standard deviation (SD) for chronological age (CA) after 3 years [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The outcome is the dosage of Insulinelike Growth Factor 1 (IGF1) in blood sample. [ Time Frame: Baseline, Month 12, Month 24, Month 36 ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: January 2005
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Somatropin Drug: 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

Ages Eligible for Study:   3 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Glucocorticosteroid treatment for 12 months at least
  • 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:

  • Known diabetes (type 1 or type 2)
  • A previous history of intolerance or hypersensitivity to the study drug or to drugs with similar chemical structures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163189

Locations
France
CHU AMIENS Service Endocrinologie-Pédiatrie
Amiens, France, 80030
Centre Hospitalier Intercommunal d'Annemasse-Bonneville, Service de Pediatrie et Neonatologie
Annemasse Cedex, France, 74107
Hopital Saint Jacques
Besancon, France, 25030
Groupe hospitalier Est- Hôpital Femme, Mère, Enfant
Bron, France, 69677
Groupe hospitalier Est-Hôpital Femme, Mère, Enfant
Bron, France, 69677
CHU d'Estaing
Clermont-Ferrand Cedex 1, France, 63003
CHU de Grenoble - Hôpital Couple enfant
Grenoble Cedex 9, France, 38043
CHU Timone Enfants
Marseille Cedex 5, France, 13385
Hôpital Arnaud De Villeneuve
Montpellier, France, 34090
CHU de Nantes, Hôpital Mère Enfant
Nantes, France, 44093
CHU de Nantes, Hôpital Mère Enfant
Nantes cedex 1, France, 44093
Hôpital Lenval
Nice, France, 06200
Hôpital Robert Debré
Paris, France, 75019
Hôpital Armand Trousseau
Paris Cedex 12, France, 75571
Groupe Hospitalier Necker - Enfants Malades
Paris cedex 15, France, 75743
Centre de Perharidy
Roscoff, France, 29684
CHU Charles Nicolle
Rouen Cedex, France, 76031
Service de Pediatrie- Centre Hospitalier Intercommunal
Saint Germain en Laye, France, 78105
Hôpital des Enfants
Toulouse Cedex 9, France, 31059
CHU Tours - Centre Pediatrique Gatien de Cocheville
Tours Cedex 1, France, 37044
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00163189     History of Changes
Other Study ID Numbers: A6281271, 2004-002992-17
Study First Received: September 9, 2005
Last Updated: February 9, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Dwarfism, Pituitary
Bone Diseases
Bone Diseases, Developmental
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Dwarfism
Endocrine System Diseases
Hypopituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases

ClinicalTrials.gov processed this record on February 27, 2015