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

Somatropin (Norditropin) in Children With Growth Failure Associated With ICF Deficiency.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00102817
Enrollment
149
Registered
2005-02-02
Start date
2003-05-31
Completion date
2006-12-31
Last updated
2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Hormone Disorder, Pituitary Dwarfism

Keywords

Growth Hormone Disorder

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.

Interventions

DRUGsomatropin

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 13 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in height standard deviation score12 months

Secondary

MeasureTime frame
12 months change in height standard deviation score adjusted for parent height z-score

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026