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

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NCT00396097

Last updated on December 5, 2018
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FOR MORE INFORMATION
Study Location
Arkansas Children's Hospital
Little Rock, Alaska, 72202 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Idiopathic Short Stature
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3-10 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

- Abnormal karyotype. Small Gestational Age and Skeletal dysplasia.

NCT00396097
Pfizer
Completed
Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature

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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
Intervention Model: Parallel Assignment
Masking: None (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.
Sexes Eligible for Study: All
3 Years to 10 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00396097
A6281280
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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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[email protected]



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