Observational Prospective Study on Patients Treated With Norditropin®

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00960128
First received: August 13, 2009
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: NordiNet® International Outcome Study-Observational Prospective Study on Patients Treated With Norditropin®

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 17000
Study Start Date: April 2006
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00960128

  Show 22 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Viatcheslav Rakov, MD Novo Nordisk Health Care AG
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00960128     History of Changes
Other Study ID Numbers: GHLIQUID-3676
Study First Received: August 13, 2009
Last Updated: May 6, 2014
Health Authority: Czech Republic: Not required for observational study
Denmark: Not required for observational study
Finland: Not required for observational study
France: Not required for observational study
Germany: Not required for observational study
Hungary: Not required for observational study
Italy: Not required for observational study
Lithuania: Not required for observational study
Norway: Not required for observational study
Russia: Not required for observational study
Serbia: Not required for observational study
Slovenia: Not required for observational study
Spain: Not required for observational study
Sweden: Not required for observational study
Switzerland: Not required for observational study
United Kingdom: Not required for observational study
Ireland: Not required for observational study
Israel: Ministry of Health
Luxembourg: Not required for observational study

Additional relevant MeSH terms:
Noonan Syndrome
Dwarfism, Pituitary
Genetic Diseases, Inborn
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Endocrine System 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
Urologic Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on July 26, 2014