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

Last updated on May 11, 2018

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Study Location
Contact
1-800-718-1021
[email protected]pfizer.com
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Growth Hormone Deficiency
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
15-20 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Males or females : Chronological age > or = 15 years and

- Chronological age > or = 17 years and

- GHD of childhood onset treated for at least 2 years

- Last GH injection at least 12 months before baseline visit

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Turner's syndrome

- Chronic hepatic impairment as shown by GGT and / or ASAT and / or ALAT > 2 X ULN

NCT00156143
Pfizer
Completed
Transition Study: Growth Hormone Therapy In Partial Growth Hormone Deficient Adolescents

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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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Growth Hormone Deficiency
  • Procedure: Blood sample
  • Procedure: Radiography
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
April 2005
Not Provided

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
Sexes Eligible for Study: All
15 Years to 20 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
France
 
NCT00156143
307-MET-9002-016
A6281018
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
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

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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