Growth Hormone Treatment in Short Children Born Small for Gestational Age

Lilly

Status and phase: Completed; Phase 3

Conditions: Infant, Small for Gestational Age

Treatments: Drug: somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191529

B9R-EW-GDGB

6581

Details and patient eligibility

About

Comparison of 2 different doses of human growth hormone treatment on change in height after 1 and 2 years of treatment.

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Born small for gestational age
• actual body height less than or equal -3 SDS
• chronological age greater than 3 years

Exclusion criteria

• Growth hormone deficiency
• any defined syndromal disease
• Diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)