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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT01578135

Collaborator

(none)

291

Enrollment

Location

138.7

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Growth Disorder Small for Gestational Age	Drug: somatropin Drug: somatropin

Study Design

Study Type:

Observational

Actual Enrollment :

291 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 18, 2007

Actual Primary Completion Date :

Oct 9, 2018

Actual Study Completion Date :

Oct 9, 2018

Arms and Interventions

Arm	Intervention/Treatment
Phase I	Drug: somatropin Patients are to fill in a questionnaire at inclusion in registry
Phase II	Drug: somatropin Patients are to fill in a questionnaire 6 months after inclusion into registry and then annually until adult height is reached

Arm

Intervention/Treatment

Phase I

Drug: somatropin

Patients are to fill in a questionnaire at inclusion in registry

Phase II

Drug: somatropin

Patients are to fill in a questionnaire 6 months after inclusion into registry and then annually until adult height is reached

Outcome Measures

Primary Outcome Measures

Growth in height [6 months after inclusion into registry and then annually until adult height is reached]

Secondary Outcome Measures

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]
Insulin-Like Growth Factor 1 (IGF-1) [6 months after inclusion into registry and then annually until adult height is reached]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Born small for gestational age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Paris La Défense		France	92936

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Clinical Trials at Novo Nordisk

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT01578135

Other Study ID Numbers:

GHSGA-1757

First Posted:

Apr 16, 2012

Last Update Posted:

Jan 14, 2020

Last Verified:

Jan 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Growth Disorders

Study Results

No Results Posted as of Jan 14, 2020