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NCT00156143 Clinical Trial

Transition Study: Growth Hormone Therapy In Partial Growth Hormone Deficient Adolescents

Growth Hormone Deficiency Clinical Trial

— TAUBER  

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00156143
Other study ID # 307-MET-9002-016
Secondary ID A6281018
Status Completed
Phase Phase 3
First received September 7, 2005
Last updated July 27, 2007
Start date April 2002
Est. completion date April 2005

Study information
Verified date July 2007
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date April 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 20 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood sample

• Radiography

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline of the % of fat mass assessed by DEXA after 1 year of treatment.
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