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Growth Response in Girls With Turner Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01734486
First received: November 22, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Genetic Disorder
Turner Syndrome
 Drug: somatropin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Turner Syndrome
Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Height gain, SDS (Standard Deviation Score) [ Designated as safety issue: No ]
  • Height gain in cm [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Height [ Designated as safety issue: No ]
  • Bone maturation [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: September 1996
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose Drug: somatropin
0.9 UI/kg/week. Subcutaneous injection for 3 years
Experimental: High dose Drug: somatropin
1.8 UI/kg/week. Subcutaneous injection for 3 years

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734486

Locations
France
TOULOUSE cedex, France, 31059
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Bruno Baron Novo Nordisk Pharmaceutique SAS
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01734486     History of Changes
Other Study ID Numbers: GHTUR/F/3
Study First Received: November 22, 2012
Last Updated: November 22, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Genetic Diseases, Inborn
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
 Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Gonadal Disorders
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 19, 2013