Back to resultsLiquid Somatropin Formulation in Children With Growth Hormone Deficiency
Primary Purpose
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
somatropin
Sponsored by
About this trial
This is an interventional treatment trial for Growth Hormone Disorder
Eligibility Criteria
Inclusion Criteria:
- Growth failure due to growth hormone insufficiency (GHD)
- Turner syndrome: established diagnosis according to sex chromosome analysis, or
- Growth retardation in children with chronic renal disorders
Exclusion Criteria:
- Pregnancy
- Breast feeding women
- Suspected or know allergy to trial product
- Participating in any other trial involving other investigational products within the last 3 months
- Previous participation in the trial
- Other daily injection therapy (non-growth hormone, e.g insulin-therapy)
Sites / Locations
- Novo Nordisk Investigational Site
Outcomes
Primary Outcome Measures
Assessment of acceptance
Secondary Outcome Measures
Safety
Adverse Events (AE)
Compliance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00567385
Brief Title
Liquid Somatropin Formulation in Children With Growth Hormone Deficiency
Official Title
An Open, Multi-centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin® SimpleXx® in Children With GH Deficiency
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 10, 2003 (Actual)
Primary Completion Date
March 22, 2004 (Actual)
Study Completion Date
March 22, 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 evaluate the acceptance of the new liquid growth hormone formulation, somatropin, in children with growth hormone deficiency.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Hormone Disorder, Growth Hormone Deficiency in Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
176 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
somatropin
Primary Outcome Measure Information:
Title
Assessment of acceptance
Time Frame
after 12 weeks of treatment
Secondary Outcome Measure Information:
Title
Safety
Title
Adverse Events (AE)
Title
Compliance
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Growth failure due to growth hormone insufficiency (GHD)
Turner syndrome: established diagnosis according to sex chromosome analysis, or
Growth retardation in children with chronic renal disorders
Exclusion Criteria:
Pregnancy
Breast feeding women
Suspected or know allergy to trial product
Participating in any other trial involving other investigational products within the last 3 months
Previous participation in the trial
Other daily injection therapy (non-growth hormone, e.g insulin-therapy)
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
Altunizade-Istanbul
ZIP/Postal Code
34662
Country
Turkey
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Liquid Somatropin Formulation in Children With Growth Hormone Deficiency
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