Treatment Of Short Stature With Genotropin In Children Born Small For Gestational Age Until Final Height

Phase 3

Completed

• Conditions: Growth Disorder

• Registration Number: NCT00174421
• Lead Sponsor: Pfizer

Brief Summary

This trial evaluates whether long-term treatment with Genotropin normalizes final (adult) height in short children born small for gestational age

Detailed Description

Not available

Study Timeline

• Study Start: 2001-04
• Study Completion: 2005-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Status Verified: 2007-05
• Last Update Submitted: 2007-05-01
• Last Update Posted: 2007-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Participation in the 90-080 study

Exclusion Criteria

• Any severe, acute or chronic disease
• Any other identifiable reason for short stature

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Final height, compared to the expected familial target height

Secondary Outcome Measures

Name	Time	Method
Body weight, body mass index at final height; adverse events and assessment of hematological and clinical chemistry