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OpenTrials
Completed

NCT Number: NCT01578135

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

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)

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Key information

Conditions

Growth Disorder Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Small for Gestational Age

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Paris La Défense, 92936, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Born small for gestational age

Treatment and study plan

Somatropin

Drug

Patients are to fill in a questionnaire at inclusion in registry

Primary outcomes

  1. Growth in height

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

Secondary outcomes

  1. Blood pressure: Systolic and diastolic

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

  2. Bone age

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

  3. Insulin-Like Growth Factor 1 (IGF-1)

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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2018
Study completion
2018
First posted
Apr 16, 2012
Registry last updated
Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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