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Use of Somatropin in Turner Syndrome

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01518036
First received: January 20, 2012
Last updated: July 10, 2012
Last verified: July 2012
History of Changes
  Purpose

This trial is conducted in Europe. The aim of this trial is to study the dose-response relationship and effect of somatropin (Norditropin®) on final height in girls with Turner Syndrome.


Condition Intervention Phase
Genetic Disorder
Turner Syndrome
 Drug: somatropin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Norditropin® in Turner's Syndrome

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:
  • Final height in cm [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ratio between change in bone age and change in chronological age [ Designated as safety issue: No ]
  • Age at onset of puberty [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: September 1987
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose Drug: somatropin
2.9 IU/m^2/day. Administered as once daily subcutaneous injection until final height is reached
Experimental: High dose Drug: somatropin
4.3 IU/m^2/day. Administered as once daily subcutaneous injection until final height is reached

  Eligibility

Ages Eligible for Study:   2 Years to 11 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Turner Syndrome
  • Not previously treated with growth hormone or androgen
  • Well-documented height over the previous 12 months
  • Informed consent of parents (and child if appropriate)

Exclusion Criteria:

  • Growth hormone (GH) deficiency based on a GH stimulation test
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01518036

Locations
United Kingdom
Crawley, United Kingdom, RH11 9RT
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Christian B. Djurhuus Novo Nordisk
  More Information

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

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01518036     History of Changes
Other Study ID Numbers: GHTUR/BPD/1
Study First Received: January 20, 2012
Last Updated: July 10, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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 16, 2013