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Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00396097
First received: November 2, 2006
Last updated: September 18, 2012
Last verified: September 2012
History of Changes

November 2, 2006
September 18, 2012
December 2006
August 2012   (final data collection date for primary outcome measure)
To demonstrate that an individualized, formula-based Genotropin regimen for children with Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th percentile (%), or -1.3 SDS) during 24 months of treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To demonstrate that an individualized, formula-based Genotropin regimen for children with Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th percentile (%), or -1.3 SDS) during 24 months of treatment
Complete list of historical versions of study NCT00396097 on ClinicalTrials.gov Archive Site
  • More uniformly achieve the desired height gain at 24 months with the goal of minimizing the variability between subjects. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Demonstrate safety of Genotropin treatment with this treatment paradigm [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Identify pharmacogenomic variants related to growth/stature [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Explore treatment efficiency over four years of two formula-based dose regimens (sub-arms) compared to standard treatment [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Explore maintained treatment efficacy at four years of two formula-based dose regimens (sub-arms) compared to standard treatment [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • More uniformly achieve the desired height gain at 24 months with the goal of minimizing the variability between subjects.
  • Demonstrate safety of Genotropin treatment with this treatment paradigm
  • Identify pharmacogenomic variants related to growth/stature
  • Explore treatment efficiency over four years of two formula-based dose regimens (sub-arms) compared to standard treatment
  • Explore maintained treatment efficacy at four years of two formula-based dose regimens (sub-arms) compared to standard treatment
Not Provided
Not Provided
 
Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature
A Four-Year Open-Label Multi-Center Randomized Two-Arm Study Of Genotropin In Idiopathic Short Stature Patients: Comparing An Individualized, Target-Driven Treatment Regimen To Standard Dosing Of Genotropin

To demonstrate that an individualized, formula-based Genotropin regimen for children with Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th percentile (%), or -1.3 SDS) during 24 months of treatment. The endpoint at 4 years is to explore treatment efficiency over four years of two formula-based dose regimens (sub-arms) compared to standard treatment
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Idiopathic Short Stature
Drug: Genotropin
Compare daily injections of formula-based HGH treatment to daily injections of standard HGH treatment in subjects with Idiopathic Short Stature over 24 months period followed by an exploratory 24 months period.
  • Active Comparator: Standard
    Standard daily HGH treatment
    Intervention: Drug: Genotropin
  • Active Comparator: Formula-based
    Formula-based dose regimen
    Intervention: Drug: Genotropin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
316
August 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Prepubertal children with bone ages between 3 and 10 years of age for males and 3 and 9 years of age for females
  • Naive to Growth Hormone treatment

Exclusion Criteria:

  • Abnormal karyotype. Small Gestational Age and Skeletal dysplasia.
Both
3 Years to 10 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00396097
A6281280
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2012

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