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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00102817
First received: February 1, 2005
Last updated: April 15, 2013
Last verified: April 2013
  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
Growth Hormone Disorder
Pituitary Dwarfism
Drug: somatropin
Phase 3

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:


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

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
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: NCT00102817

  Show 24 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: John Germak, MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00102817     History of Changes
Other Study ID Numbers: HGH-2147
Study First Received: February 1, 2005
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novo Nordisk A/S:
Growth Hormone Disorder

Additional relevant MeSH terms:
Dwarfism, Pituitary
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
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014