Effect of Growth Hormone in Children With Growth Hormone Deficiency

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Idiopathic Short Stature; Growth Hormone Deficiency in Children; Growth Disorder; Growth Hormone Disorder

Treatments: Drug: somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00262249

HGH-2051

Details and patient eligibility

About

This trial is conducted in the United States of America (USA). The purpose of the trial is to compare the effect of Norditropin® using different dosing regimens in children suspected of growth hormone deficiency.

Enrollment: 173 patients

Sex: All

Ages: 3 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically suspected GHD
• Height < -2.0 SDS
• Serum IGF-I less than or equal to -1.0 SDS
• Bone age less than or equal to 9 years for boys and less than or equal to 7 years for girls.
• Puberty Tanner Stage I

Exclusion criteria

• Previous use of growth hormone
• Growth retardation attributable to causes other than GHD (e.g. inborn errors of metabolism, primary bone disease, chromosomal disorders, etc.)
• Intrauterine growth retardation: birth weight < 3rd percentile.
• Administration of other growth-altering medications.
• Evidence of any malignancy or intracranial tumors.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)