Somatropin (Norditropin) in Insulin-Like Growth Factor (IGF) Deficient Children

This study has been completed.

First Received on February 1, 2005. Last Updated on June 12, 2009 History of Changes

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00102817

Purpose

This trial is conducted in the United States of America (USA). This is a 12 month study to determine if Norditropin is safe and effective in children with IGF deficiency.

Condition	Intervention	Phase
Dwarfism, Pituitary	Drug: somatropin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Somatropin (Norditropin) in Children With Growth Failure Associated With ICF Deficiency.

Resource links provided by NLM:

Genetics Home Reference related topics: combined pituitary hormone deficiency pseudoachondroplasia

MedlinePlus related topics: Diabetes Medicines Dwarfism

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Change in height standard deviation score [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

12 months change in height standard deviation score adjusted for parent height z-score [ Designated as safety issue: No ]

Enrollment:	149
Study Start Date:	May 2003
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	3 Years to 13 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ages 3-15, presence of growth failure indicated by height standard deviation score less than equal to -2, body mass index greater than or equal to 25th percentile for height age, IGF concentration less than or equal to 33rd percentile

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102817

Show 25 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

John Germak, MD

Novo Nordisk

More Information

Additional Information:

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

No publications provided

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00102817 History of Changes
Other Study ID Numbers:	HGH-2147
Study First Received:	February 1, 2005
Last Updated:	June 12, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novo Nordisk:

Growth Hormone Deficiency

Additional relevant MeSH terms:

Dwarfism
Dwarfism, Pituitary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases

Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012