- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01518036
Use of Somatropin in Turner Syndrome
February 27, 2017 updated by: Novo Nordisk A/S
The Use of Norditropin® in Turner's Syndrome
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
57
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Crawley, United Kingdom, RH11 9RT
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 11 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low dose
|
2.9 IU/m^2/day.
Administered as once daily subcutaneous injection until final height is reached
4.3 IU/m^2/day.
Administered as once daily subcutaneous injection until final height is reached
|
Experimental: High dose
|
2.9 IU/m^2/day.
Administered as once daily subcutaneous injection until final height is reached
4.3 IU/m^2/day.
Administered as once daily subcutaneous injection until final height is reached
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Final height in cm
|
Secondary Outcome Measures
Outcome Measure |
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Adverse events
|
Ratio between change in bone age and change in chronological age
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Age at onset of puberty
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 14, 1987
Primary Completion (Actual)
April 11, 2004
Study Completion (Actual)
April 11, 2004
Study Registration Dates
First Submitted
January 20, 2012
First Submitted That Met QC Criteria
January 20, 2012
First Posted (Estimate)
January 25, 2012
Study Record Updates
Last Update Posted (Actual)
February 28, 2017
Last Update Submitted That Met QC Criteria
February 27, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Endocrine System Diseases
- Disease
- Gonadal Disorders
- Disorders of Sex Development
- Urogenital Abnormalities
- Congenital Abnormalities
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Chromosome Disorders
- Sex Chromosome Disorders
- Sex Chromosome Disorders of Sex Development
- Syndrome
- Genetic Diseases, Inborn
- Turner Syndrome
- Gonadal Dysgenesis
Other Study ID Numbers
- GHTUR/BPD/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Turner Syndrome
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University of Colorado, DenverCompletedTurner Syndrome | Turner Syndrome Mosaicism, 45, X/46, XX or XY | Turner Syndrome Mosaicism 46,X,I(X)(Q10)/45,X | Turner Syndrome Karyotype 46,X With Abnormal Sex Chromosome , Except I(Xq)United States
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Novo Nordisk A/SRecruitingSGA, Turner Syndrome, Noonan Syndrome, ISSBelgium, Korea, Republic of, United States, Ireland, Malaysia, United Kingdom, Finland, France, Netherlands, Italy, Thailand, China, Japan, Portugal, Israel, Brazil, Greece, India, Mexico, Bulgaria, Serbia, Lithuania, Austria, Canada, C... and more
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Merck KGaA, Darmstadt, GermanyCompletedGrowth Hormon Deficiency | Turner Syndrome in Pre-pubertal Children
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Radboud University Medical CenterPrincess Beatrix Muscle FoundationCompletedParsonage Turner Syndrome | Neuralgic Amyotrophy | Neuralgic Amyotrophy, Hereditary | Brachial NeuritisNetherlands
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Verinata Health, Inc.CompletedPregnancy | Down Syndrome | Edwards Syndrome | Patau Syndrome | Turners SyndromeUnited States
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Eunice Kennedy Shriver National Institute of Child...CompletedGonadal Dysgenesis | Turner's SyndromeUnited States
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Eunice Kennedy Shriver National Institute of Child...CompletedGonadal Dysgenesis | Turner's SyndromeUnited States
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National Institute of Neurological Disorders and...Jefferson Medical College of Thomas Jefferson UniversityCompletedTurner's SyndromeUnited States
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