Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature
NCT00396097
Last updated date
ABOUT THIS STUDY
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
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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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ALL GENDERS
3 Years+
years
MULTIPLE SITES
Idiopathic Short StatureIndividualized, Target-Driven Treatment Of Children With Idiopathic Short Stature
NCT00396097
- Little Rock, Alaska
- Little Rock, Arkansas
- Los Angeles, California
- San Diego, California
- San Diego, California
- Aurora, Colorado
- Colorado Springs, Colorado
- Greenwood Village, Colorado
- Longmont, Colorado
- Hollywood, Florida
- Miami, Florida
- Miami, Florida
- Orlando, Florida
- Orlando, Florida
- Tallahassee, Florida
- Iowa City, Iowa
- Baltimore, Maryland
- Baltimore, Maryland
- Boston, Massachusetts
- Boston, Massachusetts
- Springfield, Massachusetts
- Kansas City, Missouri
- St. Louis, Missouri
- Livingston, New Jersey
- Morristown, New Jersey
- Bronx, New York
- Brooklyn, New York
- Buffalo, New York
- Lake Success, New York
- Mineola, New York
- New York, New York
- Sleepy Hollow, New York
- Columbus, Ohio
- Columbus, Ohio
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Pittsburgh, Pennsylvania
- Charleston, South Carolina
- Memphis, Tennessee
- Nashville, Tennessee
- Dallas, Texas
- Dallas, Texas
- 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 |
| |||
| 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 | 316 | |||
| Original Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| 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 | ||||