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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Growth Hormone Deficiency
 Procedure: Blood sample
Procedure: Radiography
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline of the % of fat mass assessed by DEXA after 1 year of treatment.

Estimated Enrollment: 90
Study Start Date: April 2002
Estimated Study Completion Date: April 2005
  Eligibility

Ages Eligible for Study:   15 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00156143

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00156143     History of Changes
Other Study ID Numbers: 307-MET-9002-016, A6281018
Study First Received: September 7, 2005
Last Updated: July 27, 2007
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 June 17, 2013