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
1 other identifier
interventional
316
1 country
43
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2006
Longer than P75 for phase_3
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2006
CompletedFirst Posted
Study publicly available on registry
November 6, 2006
CompletedStudy Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
November 13, 2013
CompletedApril 5, 2016
March 1, 2016
5.7 years
November 2, 2006
August 30, 2013
March 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
Variability of Height SDS at 24 Months
2 years
Time Cost (Months Until >= -2 SDS)
2 years
Computed Cost of Height Gain at 48 Months
4 years
Estimated Cost of Height Gain Estimated Until Full Adult Height (FAH) at 48 Months
4 years
Change From Baseline in Height SDS at 48 Months.
4 years
Study Arms (2)
Standard
ACTIVE COMPARATORStandard daily HGH treatment
Formula-based
ACTIVE COMPARATORFormula-based dose regimen
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Abnormal karyotype. Small Gestational Age and Skeletal dysplasia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (43)
Arkansas Children's Hospital
Little Rock, Alaska, 72202, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
Rady Children's Hospital - San Diego
San Diego, California, 32123-4282, United States
Pediatric Endocrinology of San Diego Medical Group Incorporated
San Diego, California, 92123, United States
Childrens Hospital Colorado
Aurora, Colorado, 80045, United States
Memorial Pediatric Specialty Clinic
Colorado Springs, Colorado, 80909, United States
Pediatric Endocrine Associates
Greenwood Village, Colorado, 80111, United States
Pediatric Endocrine Associates at The Longmont Clinic
Longmont, Colorado, 80501, United States
Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
Miller School Of Medicine, University of Miami/Jackson Memorial Medical Center
Miami, Florida, 33136, United States
Pediatric Endocrinology Associates
Miami, Florida, 33155, United States
Arnold Palmer Hospital for Children
Orlando, Florida, 32806, United States
Nemours Children's Clinic
Orlando, Florida, 32806, United States
Nancy Wright, MD
Tallahassee, Florida, 32308, United States
University of Iowa Children's Hospital
Iowa City, Iowa, 52242, United States
University of Maryland Baltimore
Baltimore, Maryland, 21201, United States
Johns Hopkins Pediatric Endocrinology
Baltimore, Maryland, 21205, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Children's Hospital
Boston, Massachusetts, 02115, United States
Baystate Medical Center Children's Hospital
Springfield, Massachusetts, 01199, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Children's Endocrine Care of St. Louis, LLC
St Louis, Missouri, 63141, United States
Saint Barnabas Ambulatory Care Center
Livingston, New Jersey, 07039, United States
Morristown Memorial Hospital
Morristown, New Jersey, 07962, United States
Maimonides Medical Center
Brooklyn, New York, 11219, United States
Women & Children's Hospital of Buffalo
Buffalo, New York, 14222, United States
The Steven and Alexandra Cohen Children's Medical Center of New York (CCMC)
Lake Success, New York, 11042, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Mount Sinai School of Medicine
New York, New York, 10029-6574, United States
Diabetes & Endocrine Center for Children & Young Adults at Phelps Memorial Hospital
Sleepy Hollow, New York, 10591, United States
Children's Hospital at Montefiore
The Bronx, New York, 10467-2490, United States
The Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Central Ohio Pediatric Endocrinology/Diabetes Services (COPEDS)
Columbus, Ohio, 43235, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Pediatric Alliance, PC
Pittsburgh, Pennsylvania, 15218, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
The Endocrine Clinic P.C.
Memphis, Tennessee, 38119, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
Ellen Sher, MD PA
Dallas, Texas, 75230, United States
Children's Medical Center
Dallas, Texas, 75235, United States
Cooks Children Medical Center/Dept. of Pediatric Endocrinology
Fort Worth, Texas, 76104, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2006
First Posted
November 6, 2006
Study Start
December 1, 2006
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
April 5, 2016
Results First Posted
November 13, 2013
Record last verified: 2016-03