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NCT00396097 Clinical Trial

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

Idiopathic Short Stature Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00396097
Other study ID # A6281280
Secondary ID
Status Completed
Phase Phase 3
First received November 2, 2006
Last updated December 20, 2013
Start date December 2006
Est. completion date August 2012

Study information
Verified date December 2013
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 316
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 10 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.
• 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.

Locations
Country Name City State
United States Pfizer Investigational Site Aurora Colorado
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Bronx New York
United States Pfizer Investigational Site Brooklyn New York
United States Pfizer Investigational Site Buffalo New York
United States Pfizer Investigational Site Charleston South Carolina
United States Pfizer Investigational Site Colorado Springs Colorado
United States Pfizer Investigational Site Columbus Ohio
United States Pfizer Investigational Site Columbus Ohio
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Fort Worth Texas
United States Pfizer Investigational Site Greenwood Village Colorado
United States Pfizer Investigational Site Hollywood Florida
United States Pfizer Investigational Site Iowa City Iowa
United States Pfizer Investigational Site Kansas City Missouri
United States Pfizer Investigational Site Little Rock Alaska
United States Pfizer Investigational Site Little Rock Arkansas
United States Pfizer Investigational Site Livingston New Jersey
United States Pfizer Investigational Site Longmont Colorado
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Mineola New York
United States Pfizer Investigational Site Morristown New Jersey
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site New Hyde Park New York
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Orlando Florida
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Pittsburgh Pennsylvania
United States Pfizer Investigational Site Pittsburgh Pennsylvania
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Sleepy Hollow New York
United States Pfizer Investigational Site Springfield Massachusetts
United States Pfizer Investigational Site St. Louis Missouri
United States Pfizer Investigational Site Tallahassee Florida

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Absolute On-target Difference (AOTD) at 24 Months This was defined as an absolute difference between the 24-month height standard deviation score (SDS) and targeted 24-month height SDS (10th percentile (%), or -1.3 SDS). SDS indicates how similar the participant was to the reference population. These were calculated using 2000 Center for the Disease Control (CDC) growth reference tables (by age and gender). 2 years No
Secondary Variability of Height SDS at 24 Months The continuous endpoint of variability of height SDS at 24 months was defined as the SD of the 24 month height SDS. 2 years No
Secondary Time Cost (Months Until >= -2 SDS) Time cost was defined as the number of months needed until height SDS was within the normal limit (ie, >= -2SDS). 2 years No
Secondary Computed Cost of Height Gain at 48 Months The computed cost of height gain was defined as the amount of drug used relative to the observed height-gain, in terms of mg/cm, this was calculated at Month 48. 4 years No
Secondary Estimated Cost of Height Gain Estimated Until Full Adult Height (FAH) at 48 Months The estimated cost of long-term height gain until FAH was calculated. 4 years No
Secondary Change From Baseline in Height SDS at 48 Months. Change in height SDS was measured at 48 months. 4 years No
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06382155 - A Phase 2 Study of Vosoritide in Children With Idiopathic Short Stature Phase 2
Recruiting NCT05894876 - A Study of the Genetic Basis of Response to Growth Hormone Treatment in Children With Idiopathic Short Stature
Completed NCT01246219 - Short Stature Related Distress Phase 4
Completed NCT00965484 - Genotropin Study Assessing Use of Injection Pen Phase 3
Completed NCT00710307 - Epidemiology Study on Insulin-like Growth Factor-1 in Children With Idiopathic Short Stature (EPIGROW Study)
Completed NCT01504802 - Pharmacodynamics of CNP During Growth Hormone Treatment N/A
Completed NCT01248416 - Aromatase Inhibitors, Alone And In Combination With Growth Hormone In Adolescent Boys With Idiopathic Short Stature Phase 3
Completed NCT00488124 - Growth Response in Short Children Suffering From a Disease With Growth Retardation and Treated With Somatropin Phase 2
Withdrawn NCT01438801 - Predictive Value of the Insulin-like Growth Factor-1 (IGF-1) Generation Test for the Growth Response to Growth Hormone Treatment (PRED-IGF) Phase 4
Recruiting NCT06309979 - A Study to Assess Growth in Children With Idiopathic Short Stature
Terminated NCT00121875 - Study to Identify Markers of Insulin Resistance During Growth Hormone Treatment for Short Stature Phase 4
Not yet recruiting NCT05858606 - Multidisciplinary Evaluation and a Genome-wide Analysis in a Cohort of Idiopathic Short Stature Patients N/A
Active, not recruiting NCT04020913 - Skeletal Muscle Effects of GH in Boys
Completed NCT01401244 - Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers Phase 1
Recruiting NCT02973061 - The Impact of the Use of Recombinant Human Growth Hormone on ADHD Characteristics in Children and Adolescents
Completed NCT01778023 - Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short Stature Phase 3
Recruiting NCT01604395 - Long-term Safety and Effectiveness of Growth Hormone With GHD, TS, CRF, SGA , ISS and PWS in Children
Active, not recruiting NCT00840944 - A 4 Year Combination Therapy of Growth Hormone and (GnRH) Agonist in Children With a Short Predicted Height Phase 4
Completed NCT01070173 - Ghrelin Levels in Children With Poor Growth N/A
Completed NCT01543867 - Safety and Efficacy of Long-term Somatropin Treatment in Children N/A

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