French National Longitudinal Prospective Follow-up of Children Born Small for Gestational Age and Treated With Norditropin SimpleXx (French Health Authorities Commitment)

Novo Nordisk A/S1 site in 1 country291 target enrollmentMarch 18, 2007

ConditionsGrowth Disorder Small for Gestational Age

Interventionssomatropin

Drugssomatropin

Overview

Phase: Not Applicable
Intervention: somatropin
Conditions: Growth Disorder
Sponsor: Novo Nordisk A/S
Enrollment: 291
Locations: 1
Primary Endpoint: Growth in height
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

March 18, 2007

End Date

October 9, 2018

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Born small for gestational age

Exclusion Criteria

Not provided

Arms & Interventions

Phase I

Intervention: somatropin

Phase II

Intervention: somatropin

Outcomes

Primary Outcomes

Growth in height

Time Frame: 6 months after inclusion into registry and then annually until adult height is reached

Secondary Outcomes

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)