Clinical trial NCT01502124: Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency
Official title: Norditropin® and Norditropin® Cartridges: An Open-Label, Randomized, Comparative Safety and Efficacy Trial in Children With Growth Hormone Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Growth Hormone Disorder
Growth Hormone Deficiency in Children
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-30
Enrollment: 78
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
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). The aim of this trial is to evaluate the safety profiles of Norditropin® (lyophilized somatropin) and Norditropin® cartridges (liquid somatropin) in children with growth hormone deficiency.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of short stature (height maximum 2 standard deviations of mean for age and gender) or inadequate growth deemed secondary to growth hormone deficiency (GHD)
* Naïve to growth hormone therapy

Exclusion Criteria:

* Known or suspected allergy to the trial product or related products
* Growth retardation attributable to causes other than GHD. Growth retardation attributable to diabetes mellitus, inborn errors of metabolism, primary bone disease, chromosomal disorders or disease of the genitourinary, cardiopulmonary, gastrointestinal or central nervous system; bone marrow transplantation or any syndrome known to give short stature (examples are: Prader-Willi Syndrome, Russell-Silver Syndrome, Turner Syndrome, Noonan Syndrome)
* Intrauterine growth retardation: birth weight below 3rd percentile, adjusted for gestational age
* Pregnancy or the intention to become pregnant
* Breast-feeding
* Administration of other growth-altering medication

Primary outcomes:
measure: Adverse events (especially injection site reactions)
measure: Serious adverse events
Secondary outcomes:
measure: IGF-1 (Insulin-like growth factor 1) concentration
measure: IGFBP-3 (Insulin-like growth factor binding protein 3) concentration
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Wilmington
country: United States
facility: Novo Nordisk Investigational Site
state: Delaware
city: Washington
country: United States
facility: Novo Nordisk Investigational Site
state: District of Columbia
city: Gainesville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Orlando
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Tampa
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Wichita
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Worcester
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Manhasset
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Akron
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Hershey
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Seattle
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: