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Observational Prospective Study on Patients Treated With Norditropin®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00960128
Recruitment Status : Completed
First Posted : August 17, 2009
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This observational study is conducted globally. The aim of the study is to investigate the effectiveness and safety of real-life treatment with Norditropin®. The study population will consist of children and adults who are on treatment with Norditropin® in accordance with normal clinical practice.

Condition or disease Intervention/treatment
Growth Hormone Disorder Growth Hormone Deficiency in Children Adult Growth Hormone Deficiency Genetic Disorder Turner Syndrome Foetal Growth Problem Small for Gestational Age Chronic Kidney Disease Chronic Renal Insufficiency Noonan Syndrome Drug: somatropin

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Study Type : Observational
Actual Enrollment : 21249 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: NordiNet® International Outcome Study-Observational Prospective Study on Patients Treated With Norditropin®
Actual Study Start Date : April 1, 2006
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016


Group/Cohort Intervention/treatment
A
Adult cohort
Drug: somatropin
The effectiveness and safety data collection with the use of Norditropin® in daily clinical practice with adults.

B
Paediatric cohort
Drug: somatropin
The effectiveness and safety data collection with the use of Norditropin® in daily clinical practice with children.




Primary Outcome Measures :
  1. Effect of Norditropin® treatment on height gain (change in height) in children [ Time Frame: Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study. ]
  2. Effect of Norditropin® treatment on body weight and body composition in adults [ Time Frame: Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study. ]

Secondary Outcome Measures :
  1. Effect of Norditropin® treatment body weight, blood biochemistry, bone age, the endocrine system and pubertal development in children [ Time Frame: Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study. ]
  2. Effect of Norditropin® treatment on quality of life, blood biochemistry and the endocrine system in adults [ Time Frame: Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population consists of children and adults who are on treatment with Norditropin® in accordance with normal clinical practice
Criteria

Inclusion Criteria:

  • Judged by the physician as per the Norditropin® label

Exclusion Criteria:

  • Judged by the physician as per the Norditropin® label

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00960128


Locations
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Argentina
Novo Nordisk Investigational Site
Prov. de Buenos Aires, Argentina, B1636DSU
Belgium
Novo Nordisk Investigational Site
Brussels, Belgium, 1070
Czechia
Novo Nordisk Investigational Site
Prague, Czechia, 16000
Denmark
Novo Nordisk Investigational Site
Copenhagen S, Denmark, 2300
Finland
Novo Nordisk Investigational Site
Espoo, Finland, FI-02600
France
Novo Nordisk Investigational Site
Paris La défense cedex, France, 92932
Germany
Novo Nordisk Investigational Site
Mainz, Germany, 55127
Hungary
Novo Nordisk Investigational Site
Budapest, Hungary, 1025
Ireland
Novo Nordisk Investigational Site
Dublin 2, Ireland
Israel
Novo Nordisk Investigational Site
Kfar Saba, Israel, 44425
Italy
Novo Nordisk Investigational Site
Rome, Italy, 00144
Lithuania
Novo Nordisk Investigational Site
Vilnius, Lithuania, 01112
Luxembourg
Novo Nordisk Investigational Site
Luxembourg, Luxembourg
Netherlands
Novo Nordisk Investigational Site
Alphen a/d Rijn, Netherlands
Norway
Novo Nordisk Investigational Site
Rud, Norway, 1309
Russian Federation
Novo Nordisk Investigational Site
Moscow, Russian Federation, 119330
Saudi Arabia
Novo Nordisk Investigational Site
Riyadh, Saudi Arabia, 3542
Serbia
Novo Nordisk Investigational Site
Belgrade, Serbia, 11 070
Slovenia
Novo Nordisk Investigational Site
Ljubljana, Slovenia, SI-1000
Spain
Novo Nordisk Investigational Site
Madrid, Spain, 28033
Sweden
Novo Nordisk Investigational Site
Malmö, Sweden, 202 15
Switzerland
Novo Nordisk Investigational Site
Zurich, Switzerland, CH-8050
United Kingdom
Novo Nordisk Investigational Site
Crawley, United Kingdom, RH11 9RT
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00960128    
Other Study ID Numbers: GHLIQUID-3676
2008-001674-32 ( EudraCT Number )
First Posted: August 17, 2009    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Dwarfism, Pituitary
Noonan Syndrome
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Turner Syndrome
Genetic Diseases, Inborn
Endocrine System Diseases
Disease
Syndrome
Pathologic Processes
Urologic Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Gonadal Dysgenesis
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases