Transition Study: Growth Hormone Therapy In Partial Growth Hormone Deficient Adolescents (TAUBER)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00156143
First received: September 7, 2005
Last updated: July 27, 2007
Last verified: July 2007

September 7, 2005
July 27, 2007
April 2002
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Change from baseline of the % of fat mass assessed by DEXA after 1 year of treatment.
Same as current
Complete list of historical versions of study NCT00156143 on ClinicalTrials.gov Archive Site
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Transition Study: Growth Hormone Therapy In Partial Growth Hormone Deficient Adolescents
GH Therapy in Partial GHD Adolescents : Evaluation of Efficacy Based on Body Composition and Comparison of 2 Different Doses of Genotonorm®. Open-Label, Randomised, Comparative, Controlled, Parallel-Group, Multi-Center Phase IIIB Clinical Trial.

To evaluate in boys and girls the improvement in body composition under GH treatment in adolescents with CO-GHD who remain partially GHD after GH discontinuation.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Growth Hormone Deficiency
  • Procedure: Blood sample
  • Procedure: Radiography
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
April 2005
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Inclusion Criteria:

  • Males or females : Chronological age > or = 15 years and < or = 20 years for females
  • Chronological age > or = 17 years and < or = 20 years for males
  • GHD of childhood onset treated for at least 2 years
  • Last GH injection at least 12 months before baseline visit

Exclusion Criteria:

  • Turner's syndrome
  • Chronic hepatic impairment as shown by GGT and / or ASAT and / or ALAT > 2 X ULN
Both
15 Years to 20 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00156143
307-MET-9002-016, A6281018
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Pfizer
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Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP