Efficacy on Height in SGA Children Treated With Growth Hormone

Phase 3

Completed

• Conditions: Foetal Growth Problem; Small for Gestational Age

• Registration Number: NCT00184756
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluate effect on Height in SGA Children Treated with Growth Hormone	After 2 years of treatment

Secondary Outcome Measures

Name	Time	Method
Appetite
Height SDS, yearly

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇪 Örebro, Sweden