Effect of Two Years Treatment With Growth Hormone on Height in SGA Children.

Novo Nordisk A/S1 site in 1 country151 target enrollmentNovember 2002

ConditionsFoetal Growth Problem Small for Gestational Age

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Foetal Growth Problem
Sponsor: Novo Nordisk A/S
Enrollment: 151
Locations: 1
Primary Endpoint: Evaluate effect on Height in SGA Children Treated with Growth Hormone
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 2002

End Date

July 2006

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility 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