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Growth Response in Girls With Turner Syndrome

NCT ID: NCT01734486

Last Updated: 2017-02-28

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

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-09-23

Study Completion Date

2003-05-21

Brief Summary

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This trial is conducted in Europe. The aim of the trial is to evaluate growth response of two somatropin dose regimens in girls with Turner Syndrome.

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Detailed Description

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Conditions

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Genetic Disorder Turner Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low dose

Group Type EXPERIMENTAL

somatropin

Intervention Type DRUG

0.9 UI/kg/week. Subcutaneous injection for 3 years

High dose

Group Type EXPERIMENTAL

somatropin

Intervention Type DRUG

1.8 UI/kg/week. Subcutaneous injection for 3 years

Interventions

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somatropin

0.9 UI/kg/week. Subcutaneous injection for 3 years

Intervention Type DRUG

somatropin

1.8 UI/kg/week. Subcutaneous injection for 3 years

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Turner syndrome
* If age below 3 years, either body height below - 1 SD (standard deviation) with average growth velocity according to chronological age or body height below 0 SD with growth velocity below -1 SD according to chronological age
* If age above 3 years, body height below - 1 SD with average growth velocity according to chronological age
* Measured parental height available
* Written informed consent
Eligible Sex

FEMALE

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

Besançon, , France

Site Status

Novo Nordisk Investigational Site

Bordeaux, , France

Site Status

Novo Nordisk Investigational Site

Dunkirk, , France

Site Status

Novo Nordisk Investigational Site

Grenoble, , France

Site Status

Novo Nordisk Investigational Site

Lille, , France

Site Status

Novo Nordisk Investigational Site

Lorient, , France

Site Status

Novo Nordisk Investigational Site

Nice, , France

Site Status

Novo Nordisk Investigational Site

Paris, , France

Site Status

Novo Nordisk Investigational Site

Reims, , France

Site Status

Novo Nordisk Investigational Site

Rennes, , France

Site Status

Novo Nordisk Investigational Site

Rouen, , France

Site Status

Novo Nordisk Investigational Site

Tarbes, , France

Site Status

Novo Nordisk Investigational Site

Toulouse, , France

Site Status

Novo Nordisk Investigational Site

Tours, , France

Site Status

Novo Nordisk Investigational Site

Vandœuvre-lès-Nancy, , 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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GHTUR/F/3

Identifier Type: -

Identifier Source: org_study_id

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