NCT00156143CompletedPhase 3
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.
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 90
- Primary Endpoint
- Change from baseline of the % of fat mass assessed by DEXA after 1 year of treatment.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 20 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change from baseline of the % of fat mass assessed by DEXA after 1 year of treatment.
Secondary Outcomes
No secondary outcomes reported
Investigators
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