Back to resultsTreatment Of Short Stature With Genotropin In Children Born Small For Gestational Age Until Final Height
Primary Purpose
Growth Disorder
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Treatment with Genotropin in different dosages
Sponsored by
About this trial
This is an interventional treatment trial for Growth Disorder
Eligibility Criteria
Inclusion Criteria: Participation in the 90-080 study Exclusion Criteria: Any severe, acute or chronic disease Any other identifiable reason for short stature
Sites / Locations
Outcomes
Primary Outcome Measures
Final height, compared to the expected familial target height
Secondary Outcome Measures
Body weight, body mass index at final height; adverse events and assessment of hematological and clinical chemistry
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00174421
Brief Title
Treatment Of Short Stature With Genotropin In Children Born Small For Gestational Age Until Final Height
Official Title
Genotropin in Short Children Born Small for Gestational Ag - A Long-Term Study in Belgium
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
This trial evaluates whether long-term treatment with Genotropin normalizes final (adult) height in short children born small for gestational age
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Treatment with Genotropin in different dosages
Primary Outcome Measure Information:
Title
Final height, compared to the expected familial target height
Secondary Outcome Measure Information:
Title
Body weight, body mass index at final height; adverse events and assessment of hematological and clinical chemistry
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participation in the 90-080 study
Exclusion Criteria:
Any severe, acute or chronic disease
Any other identifiable reason for 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 Short Stature With Genotropin In Children Born Small For Gestational Age Until Final Height
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