Transition Study: Growth Hormone Therapy In Partial Growth Hormone Deficient Adolescents - Full Text View

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

This study has been completed.

First Received: September 7, 2005 Last Updated: July 27, 2007 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00156143

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 III

Genetics Home Reference related topics: pseudoachondroplasia

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
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.

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

Additional Information:

Links to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	307-MET-9002-016, A6281018
Study First Received:	September 7, 2005
Last Updated:	July 27, 2007
ClinicalTrials.gov Identifier:	NCT00156143 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Dwarfism
Bone Diseases, Endocrine
Hypothalamic Diseases
Hypopituitary Dwarfism
Pituitary Diseases
Central Nervous System Diseases
Endocrine System Diseases
Dwarfism, Pituitary

Brain Diseases
Hormones
Bone Diseases
Musculoskeletal Diseases
Hypopituitarism
Growth Hormone Deficiency
Bone Diseases, Developmental
Endocrinopathy

Additional relevant MeSH terms:

Dwarfism
Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Nervous System Diseases
Central Nervous System Diseases
Endocrine System Diseases

Dwarfism, Pituitary
Brain Diseases
Bone Diseases
Musculoskeletal Diseases
Hypopituitarism
Bone Diseases, Developmental

ClinicalTrials.gov processed this record on May 06, 2009