Effect of Growth Hormone in Children With Growth Hormone Deficiency

• Status: Completed
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Hormones

Criteria

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.