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Observational Prospective Study on Patients Treated With Norditropin®

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00960128
First received: August 13, 2009
Last updated: August 16, 2017
Last verified: August 2017
  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. ]
  • 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:
  • 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. ]
  • 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. ]

Enrollment: 21249
Actual Study Start Date: April 1, 2006
Study Completion Date: December 31, 2016
Primary Completion Date: December 31, 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

Ages Eligible for Study:   Child, Adult, Senior
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
  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 23 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00960128     History of Changes
Other Study ID Numbers: GHLIQUID-3676
2008-001674-32 ( EudraCT Number )
Study First Received: August 13, 2009
Last Updated: August 16, 2017

Additional relevant MeSH terms:
Noonan Syndrome
Disease
Syndrome
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Endocrine System Diseases
Dwarfism, Pituitary
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
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
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 20, 2017