Observational Prospective Study on Patients Treated With Norditropin® - Full Text View

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00960128

Purpose

This study is conducted in Europe. The aim of this observational 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 already being treated with Norditropin® or who are candidates for treatment with Norditropin®.

Condition	Intervention
Growth Hormone Deficiency (GHD) Growth Hormone Deficiency, Adults (GHDA) Turner Syndrome Small for Gestational Age (SGA) Chronic Renal Insufficiency Noonan Syndrome	Drug: somatropin

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

Resource links provided by NLM:

Genetics Home Reference related topics: Baller-Gerold syndrome Crouzon syndrome Noonan syndrome pseudoachondroplasia Turner syndrome

MedlinePlus related topics: Turner Syndrome

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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 3 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 3 years in accordance with defined duration of the study. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Effect of Norditropin® treatment on glucose metabolism, body weight, blood biochemistry, bone age, primary tumour occurrence or reoccurrence, 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 3 years in accordance with defined duration of the study. ] [ Designated as safety issue: Yes ]
Effect of Norditropin® treatment on quality of life, glucose metabolism, tumour status, 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 3 years in accordance with defined duration of the study. ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	10000
Study Start Date:	April 2006
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (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 already being treated with Norditropin® or who are judged by the physician as candidates for treatment with Norditropin®.

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

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

Contacts

Contact: Public Access to Clinical Trials - Novo Nordisk

Please Contact NN via email

clinicaltrials@novonordisk.com

Show 21 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Viatcheslav Rakov, MD

Novo Nordisk Health Care AG

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	GHLIQUID-3676
Study First Received:	August 13, 2009
Last Updated:	February 5, 2010
ClinicalTrials.gov Identifier:	NCT00960128 History of Changes
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; Netherlands: 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; Sweden: Not required for observational study; Switzerland: Not required for observational study; United Kingdom: Not required for observational study; Argentina: Not required for observational study; Saudi Arabia: Not required for observational study; Brazil: Not required for observational study; Ireland: Not required for observational study; Israel: Ministry of Health

Additional relevant MeSH terms:

Bone Diseases, Endocrine
Dwarfism
Renal Insufficiency
Gonadal Disorders
Craniofacial Abnormalities
Dwarfism, Pituitary
Brain Diseases
Sex Differentiation Disorders
Bone Diseases
Musculoskeletal Abnormalities
Urogenital Abnormalities
Pathologic Processes
Urologic Diseases
Hypopituitarism
Musculoskeletal Diseases

Syndrome
Bone Diseases, Developmental
Connective Tissue Diseases
Kidney Diseases
Noonan Syndrome
Congenital Abnormalities
Hypothalamic Diseases
Disease
Pituitary Diseases
Nervous System Diseases
Chromosome Disorders
Endocrine System Diseases
Central Nervous System Diseases
Turner Syndrome
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on February 08, 2010