Back to resultsUse of Somatropin in Turner Syndrome
Primary Purpose
Genetic Disorder, Turner Syndrome
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
somatropin
somatropin
Sponsored by
About this trial
This is an interventional treatment trial for Genetic Disorder
Eligibility 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
Sites / Locations
- 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
Final height in cm
Secondary Outcome Measures
Ratio between change in bone age and change in chronological age
Age at onset of puberty
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01518036
Brief Title
Use of Somatropin in Turner Syndrome
Official Title
The Use of Norditropin® in Turner's Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 14, 1987 (Actual)
Primary Completion Date
April 11, 2004 (Actual)
Study Completion Date
April 11, 2004 (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 this trial is to study the dose-response relationship and effect of somatropin (Norditropin®) on final height 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 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (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
2.9 IU/m^2/day. Administered as once daily subcutaneous injection until final height is reached
Intervention Type
Drug
Intervention Name(s)
somatropin
Intervention Description
4.3 IU/m^2/day. Administered as once daily subcutaneous injection until final height is reached
Primary Outcome Measure Information:
Title
Final height in cm
Secondary Outcome Measure Information:
Title
Ratio between change in bone age and change in chronological age
Title
Age at onset of puberty
Title
Adverse events
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
Crawley
ZIP/Postal Code
RH11 9RT
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Use of Somatropin in Turner Syndrome
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