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

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Pituitary Dwarfism; Growth Hormone Disorder

Treatments: Drug: somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00102817

HGH-2147

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: All

Ages: 3 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)