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

NCT00156143

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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.
Show details

- 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
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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Transition Study: Growth Hormone Therapy In Partial Growth Hormone Deficient Adolescents
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Growth Hormone Deficiency
Intervention  ICMJE
  • Procedure: Blood sample
  • Procedure: Radiography
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 9, 2005)
90
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE April 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 15 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries France
 
Administrative Information
NCT Number  ICMJE NCT00156143
Other Study ID Numbers  ICMJE 307-MET-9002-016
A6281018
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP