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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00102817
First received: February 1, 2005
Last updated: January 17, 2017
Last verified: January 2017
  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
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 ]

Secondary Outcome Measures:
  • 12 months change in height standard deviation score adjusted for parent height z-score

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   (Child)
Sexes Eligible for Study:   All
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 27 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:
Cohen P, Rogol A, Kappelgaard A-M, Weng W, Germak J, Rosenfeld RG on behalf of the American Norditropin Study Group. Efficacy of IGF-I Based Growth Hormone (GH) Dose Titration in Non-GH Deficient (Non-GHD) Children with Short Stature Associated with IGF-I Deficiency (IGFD). Pediatric Academic Societies (PAS)/Lawson Wilkins Pediatric Endocrine Society (LWPES) 2007; Country: Canada City: Toronto
Cohen P, Rosenfeld R, Rogol A, Kappelgaard A-M, Mak C, Germak J. Validation of the Efficacy and Safety of IGF-based Dose-titration in Children with Growth Failure Associated with Non-GH-deficient, IGF-I Deficiency: Results of Clinical Trial HGH 2147 on Behalf of the American Norditropin® Clinical Studies Group. 3rd International Congress of the Growth Hormone Research Society and the IGF Society 2006; Country: Japan City: Kobe

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: 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: January 17, 2017

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

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 April 26, 2017