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

NCT00396097

Last updated date
Study Location
Arkansas Children's Hospital
Little Rock, Alaska, 72202, United States
Contact
1-800-718-1021

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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.

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Idiopathic Short StatureIndividualized, Target-Driven Treatment Of Children With Idiopathic Short Stature
NCT00396097
  1. Little Rock, Alaska
  2. Little Rock, Arkansas
  3. Los Angeles, California
  4. San Diego, California
  5. San Diego, California
  6. Aurora, Colorado
  7. Colorado Springs, Colorado
  8. Greenwood Village, Colorado
  9. Longmont, Colorado
  10. Hollywood, Florida
  11. Miami, Florida
  12. Miami, Florida
  13. Orlando, Florida
  14. Orlando, Florida
  15. Tallahassee, Florida
  16. Iowa City, Iowa
  17. Baltimore, Maryland
  18. Baltimore, Maryland
  19. Boston, Massachusetts
  20. Boston, Massachusetts
  21. Springfield, Massachusetts
  22. Kansas City, Missouri
  23. St. Louis, Missouri
  24. Livingston, New Jersey
  25. Morristown, New Jersey
  26. Bronx, New York
  27. Brooklyn, New York
  28. Buffalo, New York
  29. Lake Success, New York
  30. Mineola, New York
  31. New York, New York
  32. Sleepy Hollow, New York
  33. Columbus, Ohio
  34. Columbus, Ohio
  35. Philadelphia, Pennsylvania
  36. Pittsburgh, Pennsylvania
  37. Pittsburgh, Pennsylvania
  38. Charleston, South Carolina
  39. Memphis, Tennessee
  40. Nashville, Tennessee
  41. Dallas, Texas
  42. Dallas, Texas
  43. Fort Worth, Texas
ALL GENDERS
3 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature
Official Title  ICMJE 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
Brief Summary 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
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 Idiopathic Short Stature
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: Standard
    Standard daily HGH treatment
    Intervention: Drug: Genotropin
  • Active Comparator: Formula-based
    Formula-based dose regimen
    Intervention: Drug: Genotropin
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
Actual Enrollment  ICMJE
 (submitted: September 18, 2012)
316
Original Enrollment  ICMJE
 (submitted: November 2, 2006)
312
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 3 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00396097
Other Study ID Numbers  ICMJE A6281280
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2016

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