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

NCT ID: NCT01578135

Last Updated: 2022-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

291 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-18

Study Completion Date

2018-10-09

Brief Summary

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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)

Detailed Description

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Conditions

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Growth Disorder Small for Gestational Age

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Phase I

somatropin

Intervention Type DRUG

Patients are to fill in a questionnaire at inclusion in registry

Phase II

somatropin

Intervention Type DRUG

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

Interventions

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somatropin

Patients are to fill in a questionnaire at inclusion in registry

Intervention Type DRUG

somatropin

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Born small for gestational age
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Paris La Défense, , France

Site Status

Countries

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France

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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GHSGA-1757

Identifier Type: -

Identifier Source: org_study_id

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