- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00567385
Liquid Somatropin Formulation in Children With Growth Hormone Deficiency
February 27, 2017 updated by: Novo Nordisk A/S
An Open, Multi-centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin® SimpleXx® in Children With GH Deficiency
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
176
Phase
- Phase 4
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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Altunizade-Istanbul, Turkey, 34662
- 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
3 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of acceptance
Time Frame: after 12 weeks of treatment
|
after 12 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
---|
Safety
|
Compliance
|
Adverse Events (AE)
|
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)
March 10, 2003
Primary Completion (Actual)
March 22, 2004
Study Completion (Actual)
March 22, 2004
Study Registration Dates
First Submitted
November 30, 2007
First Submitted That Met QC Criteria
December 3, 2007
First Posted (Estimate)
December 4, 2007
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
Other Study ID Numbers
- GHLIQUID-1515
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.
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Novo Nordisk A/SCompletedHealthy | Growth Hormone DisorderGermany
Clinical Trials on somatropin
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Novo Nordisk A/SCompletedNoonan Syndrome | Genetic DisorderSweden
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Novo Nordisk A/SCompletedNoonan Syndrome | Genetic DisorderJapan
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LG ChemCompletedBioavailability, Safety and Tolerability Among Different Eutropin Formulations in Healthy VolunteersKorea, Republic of
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Novo Nordisk A/SCompletedFoetal Growth Problem | Small for Gestational AgeJapan
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Novo Nordisk A/SCompletedAchondroplasia | Genetic DisorderJapan
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Novo Nordisk A/SCompletedNoonan Syndrome | Genetic DisorderSweden