Clinical trial NCT00102817: Somatropin (Norditropin) in Insulin-like Growth Factor (IGF) Deficient Children
Official title: Somatropin (Norditropin) in Children With Growth Failure Associated With ICF Deficiency.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Growth Hormone Disorder
Pituitary Dwarfism
Keywords: Growth Hormone Disorder
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2005-02-02
Enrollment: 149
Sex: ALL
Minimum age (years): 3
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Change in height standard deviation score
timeFrame: 12 months
Secondary outcomes:
measure: 12 months change in height standard deviation score adjusted for parent height z-score
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: San Diego
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Stanford
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: St. Petersburg
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Tallahassee
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Tampa
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Indianapolis
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
city: Boston
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Worcester
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Kalamazoo
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: Novo Nordisk Investigational Site
state: Minnesota
city: Kansas City
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Bronx
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Brooklyn
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Buffalo
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Rockville Centre
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Akron
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Novo Nordisk Investigational Site
state: Oklahoma
city: Hershey
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Seattle
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: Novo Nordisk Investigational Site
state: Wisconsin
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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
citation: 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
citation: Cohen P, Rogol AD, Weng W, Kappelgaard AM, Rosenfeld RG, Germak J; American Norditropin Study Group. Efficacy of IGF-based growth hormone (GH) dosing in nonGH-deficient (nonGHD) short stature children with low IGF-I is not related to basal IGF-I levels. Clin Endocrinol (Oxf). 2013 Mar;78(3):405-14. doi: 10.1111/cen.12014.