Overview

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.