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NCT01578135 Clinical Trial

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

Small for Gestational Age Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01578135
Other study ID # GHSGA-1757
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 18, 2007
Est. completion date October 9, 2018

Study information
Verified date October 2022
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)

Recruitment information / eligibility
Status Completed
Enrollment 291
Est. completion date October 9, 2018
Est. primary completion date October 9, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Born small for gestational age

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Novo Nordisk Investigational Site Paris La Défense

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Growth in height 6 months after inclusion into registry and then annually until adult height is reached
Secondary Blood pressure: Systolic and diastolic 6 months after inclusion into registry and then annually until adult height is reached
Secondary Bone age 6 months after inclusion into registry and then annually until adult height is reached
Secondary Insulin-Like Growth Factor 1 (IGF-1) 6 months after inclusion into registry and then annually until adult height is reached
See also
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Recruiting NCT02964793 - Effects of Serial Plotting on Fundal Height Charts on Identification and Outcomes of Small for Gestational Age Infants N/A
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