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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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16 October 2017 |
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Main ID: |
EUCTR2008-001674-32-FI |
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Date of registration:
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25/08/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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NordiNet International Outcome Study (NordiNet IOS) - NordiNet IOS
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Scientific title:
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NordiNet International Outcome Study (NordiNet IOS) - NordiNet IOS |
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Date of first enrolment:
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29/04/2009 |
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Target sample size:
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17000 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001674-32 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Finland
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
The study population will consist of children and adults who are on treatment with Norditropin® in accordance with normal clinical practice.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
As per Norditropin SPC
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Small Gestation Age, Turner Syndrome, Growth Hormone Deficiency
MedDRA version: 16.1
Level: PT
Classification code 10056438
Term: Growth hormone deficiency
System Organ Class: 10014698 - Endocrine disorders
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Intervention(s)
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Trade Name: Norditropin
Pharmaceutical Form: Injection
INN or Proposed INN: somatotropine
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Primary Outcome(s)
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Secondary Objective: To gather the data of patients using Norditropin to same data base (NordiNet) to help the clinicians every-day work.
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Main Objective: To collect the post-marketing data on effectiviness and safety of real-life treatment with Norditropin.
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Primary end point(s): Effectiviness endpoints: effect of Norditropin on height gain, glucose metabolism, the cardiovascular system, body weight/composition, blood chemistry, bone status, primary tumour occurrence or reoccurrence, the endocrine system and pubertal development. Safety endpoints: adverse reactions and severe adverse events, deteriorative changes in clinical and laboratory parameters.
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Secondary ID(s)
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NordiNet-IOS
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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