Efficacy and Safety of Growth Hormone Treatment in Children Small for Gestational Age

Phase 3

Completed

• Conditions: Foetal Growth Problem; Small for Gestational Age

• Registration Number: NCT00557336
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this clinical trial is to evaluate the height gain during 12 months of growth hormone treatment in children born small for gestational age due to intrauterine growth retardation.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07-28
• Primary Completion: 2005-06-29
• Study Completion: 2005-06-29
• Study First Submitted: 2007-11-12
• Study First Submitted QC: 2007-11-12
• Study First Posted: 2007-11-14
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Born small for gestational age (SGA) due to intrauterine growth retardation (IUGR) defined as birth length and/or weight below P10
• Chronological age at least 4 years old until bone age maturation of maximum 12 years for girls and maximum 13,5 for boys at time of inclusion in the study
• Insufficient catch-up growth (height lesser than or equal to -2.5 SDS for chronological age
• Normal response to GH stimulation test (greater than 10 ng/mL)

Exclusion Criteria

• Diabetes
• Growth retardation associated with infections severe chronic diseases (including chromosomal anomaly or nutritional disorders)
• Treatment with any medical product (anabolic drugs, sex steroids, etc.) which may interfere with GH effects
• History or presence of severe disease that could interfere with GH treatment/participation in the trial, e.g. active malignancy
• Previous or ongoing growth hormone therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Height gain according to birth group, age of onset, the treatment and Tanner stage	during 12 months of treatment

Secondary Outcome Measures

Name	Time	Method
Height SDS for bone age	during 12 months of treatment
Height velocity SDS for bone age	during 12 months of treatment
Height velocity for chronological age	during 12 months of treatment

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇪🇸 Zaragoza, Spain