Efficacy on Height in SGA Children Treated With Growth Hormone

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Europe and Middle East. Growth hormone in SGA Children This trial compares a treated group of patients with an untreated group of patients.

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

Details

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

Criteria

Inclusion Criteria:

• Born small for gestational age with length and/or weight at -2 SDS or below at time of birth, according to country specific references.

• Severe growth failure with no catch up and with height at -2.5 SDS or below, according to country specific references, for chronological age at time of inclusion

Exclusion Criteria:

• Growth Hormone Deficiency (GHD)

• Treatment with any medical product which may interfere with GH effects

• Growth retardation associated with infections, severe chronic diseases including chromosomal anomaly or nutritional disorders