Back to resultsTreatment Of Children With Short Stature At An Age Of 3-7 Years Who Were Born Small For Gestational Age
Primary Purpose
Growth Disorders
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Genotropin
Sponsored by
About this trial
This is an interventional treatment trial for Growth Disorders
Eligibility Criteria
Inclusion Criteria: Birth length below -2 SD Height at start below - 2 Sd Exclusion Criteria: Any endocrine or chronic disease Any known syndrome with short stature
Sites / Locations
Outcomes
Primary Outcome Measures
Height, height velocity
Secondary Outcome Measures
Side effects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00174408
Brief Title
Treatment Of Children With Short Stature At An Age Of 3-7 Years Who Were Born Small For Gestational Age
Official Title
Growth Hormone Treatment in Short Children Born Small for Date (Genotonorm)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
March 1990 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
The primary objective is to evaluate, if Genotonorm (Genotropin) increases linear growth in short children born SGA. Safety of the drug is a main objective as well. The growth promoting effect of two different dosages is compared. The effect of long-term treatment on final height is evaluated (according to several amendments)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Genotropin
Primary Outcome Measure Information:
Title
Height, height velocity
Secondary Outcome Measure Information:
Title
Side effects
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Birth length below -2 SD
Height at start below - 2 Sd
Exclusion Criteria:
Any endocrine or chronic disease
Any known syndrome with short stature
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Treatment Of Children With Short Stature At An Age Of 3-7 Years Who Were Born Small For Gestational Age
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