French National Registry of Children Born Small for Gestational Age Treated With Somatropin

Completed

• Conditions: Growth Disorder; Small for Gestational Age
• Interventions: Drug: somatropin

• Registration Number: NCT01578135
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Europe. The aim of the study is to describe the patient population and therapeutic practices (study phase I), assess efficacy on growth and adult height and assess tolerance of somatropin (Norditropin® SimpleXx®) (study phase II)

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-18
• Study First Submitted: 2012-04-13
• Study First Submitted QC: 2012-04-13
• Study First Posted: 2012-04-16
• Primary Completion: 2018-10-09
• Study Completion: 2018-10-09
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-19
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 291

Inclusion Criteria

• Born small for gestational age

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Phase I	somatropin	-
Phase II	somatropin	-

Primary Outcome Measures

Name	Time	Method
Growth in height	6 months after inclusion into registry and then annually until adult height is reached

Secondary Outcome Measures

Name	Time	Method
Insulin-Like Growth Factor 1 (IGF-1)	6 months after inclusion into registry and then annually until adult height is reached
Blood pressure: Systolic and diastolic	6 months after inclusion into registry and then annually until adult height is reached
Bone age	6 months after inclusion into registry and then annually until adult height is reached

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇫🇷 Paris La Défense, France