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

October 19, 2022 updated by: Novo Nordisk A/S

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

291

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris La Défense, France, 92936
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Phase I: All patients born SGA treated with Norditropin® SimpleXx® (somatropin) whether they were previously treated with another growth hormone for this indication or not from the 29th of April 2005 until 29th of April 2010.

Phase II: Sub-population randomly selected (every 5th patient being included in registry in study phase I).

Description

Inclusion Criteria:

  • Born small for gestational age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 18, 2007

Primary Completion (ACTUAL)

October 9, 2018

Study Completion (ACTUAL)

October 9, 2018

Study Registration Dates

First Submitted

April 13, 2012

First Submitted That Met QC Criteria

April 13, 2012

First Posted (ESTIMATE)

April 16, 2012

Study Record Updates

Last Update Posted (ACTUAL)

October 20, 2022

Last Update Submitted That Met QC Criteria

October 19, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHSGA-1757

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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