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Growth Response in Girls With Turner Syndrome

Primary Purpose

Genetic Disorder, Turner Syndrome

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
somatropin
somatropin
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genetic Disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low dose

High dose

Arm Description

Outcomes

Primary Outcome Measures

Height gain, SDS (Standard Deviation Score)
Height gain in cm

Secondary Outcome Measures

Height
Bone maturation

Full Information

First Posted
November 22, 2012
Last Updated
February 27, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01734486
Brief Title
Growth Response in Girls With Turner Syndrome
Official Title
Growth Response in Girls With Turner Syndrome During a Three-year GH Treatment Comparing Two Dose Regimens. Identification of Predictive Factors of Growth Response
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 23, 1996 (Actual)
Primary Completion Date
May 21, 2003 (Actual)
Study Completion Date
May 21, 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genetic Disorder, Turner Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose
Arm Type
Experimental
Arm Title
High dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
somatropin
Intervention Description
0.9 UI/kg/week. Subcutaneous injection for 3 years
Intervention Type
Drug
Intervention Name(s)
somatropin
Intervention Description
1.8 UI/kg/week. Subcutaneous injection for 3 years
Primary Outcome Measure Information:
Title
Height gain, SDS (Standard Deviation Score)
Title
Height gain in cm
Secondary Outcome Measure Information:
Title
Height
Title
Bone maturation

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Dunkerque
ZIP/Postal Code
59385
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Lorient
Country
France
Facility Name
Novo Nordisk Investigational Site
City
NICE cedex 3
ZIP/Postal Code
06202
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Paris
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Reims
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Rennes
ZIP/Postal Code
35056
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Tarbes
Country
France
Facility Name
Novo Nordisk Investigational Site
City
TOULOUSE cedex
ZIP/Postal Code
31059
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France

12. IPD Sharing Statement

Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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Growth Response in Girls With Turner Syndrome

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