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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00163189
First received: September 9, 2005
Last updated: July 21, 2014
Last verified: July 2014
  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 Glucocorticosteroid Therapy and Treated By Genotonorm (Registered)

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 ]

Estimated Enrollment: 120
Study Start Date: January 2005
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (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:   11 Years to 13 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
Pfizer Investigational Site
Amiens, France, 80030
Pfizer Investigational Site
Annemasse Cedex, France, 74107
Pfizer Investigational Site
Besancon, France, 25030
Pfizer Investigational Site
Bron, France, 69677
Pfizer Investigational Site
Clermont-Ferrand Cedex 1, France, 63003
Pfizer Investigational Site
Grenoble Cedex 9, France, 38043
Pfizer Investigational Site
Marseille Cedex 5, France, 13385
Pfizer Investigational Site
Montpellier, France, 34090
Pfizer Investigational Site
Nantes, France, 44093
Pfizer Investigational Site
Nantes cedex 1, France, 44093
Pfizer Investigational Site
Nice, France, 06200
Pfizer Investigational Site
Paris, France, 75019
Pfizer Investigational Site
Paris Cedex 12, France, 75571
Pfizer Investigational Site
Paris cedex 15, France, 75743
Pfizer Investigational Site
Roscoff, France, 29684
Pfizer Investigational Site
Rouen Cedex, France, 76031
Pfizer Investigational Site
Saint Germain en Laye, France, 78105
Pfizer Investigational Site
Toulouse Cedex 9, France, 31059
Pfizer Investigational Site
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
Study First Received: September 9, 2005
Last Updated: July 21, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on July 24, 2014