Somatropin (Norditropin) in Insulin-like Growth Factor (IGF) Deficient Children

Phase 3

Completed

• Conditions: Pituitary Dwarfism; Growth Hormone Disorder

• Registration Number: NCT00102817
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in the United States of America (USA). This is a 12 month study to determine if Norditropin is safe and effective in children with IGF deficiency.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2005-02-01
• Study First Submitted QC: 2005-02-01
• Study First Posted: 2005-02-02
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-17
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

• Ages 3-15
• Presence of growth failure indicated by height standard deviation score less than equal to -2
• Body mass index greater than or equal to 25th percentile for height age
• IGF concentration less than or equal to 33rd percentile

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in height standard deviation score	12 months

Secondary Outcome Measures

Name	Time	Method
12 months change in height standard deviation score adjusted for parent height z-score

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Milwaukee, Wisconsin, United States