Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short Stature

Idiopathic Short Stature Clinical Trial

Official title:

A 12-month, Open-labelled, Randomised, Parallel-group, Multi-centre, Interventional Trial to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone (hGH) (Norditropin® Nordilet®) Therapy on Height Velocity (Ht-V) in Patients With Idiopathic Short Stature in Korea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01778023
• Other study ID #: GH-3899
• Secondary ID: U1111-1125-47902
• Status: Completed
• Phase: Phase 3
• First received: January 24, 2013
• Last updated: November 27, 2015
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: November 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of recombinant human growth hormone (hGH) in subjects with idiopathic short stature in Korea.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 11 Years

Eligibility

Inclusion Criteria:

• Informed consent obtained from subject's parents or legally acceptable representative before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)

• Pre-pubertal status (males aged from 4 to 11 [both inclusive], females aged from 4 to 9 [both inclusive]): an absence of breast development in females (Tanner 1 only) and testicular volume below 4 mL in males

• Growth hormone level above 10 ng/mL following a stimulation test (test result within 6 months from screening can be used)

• Height below 3 percentile

• Bone age below or equal to 12 year

• Epiphyses confirmed as open in patients at least 10 years or more of age

Exclusion Criteria:

• Known presence of one or more pituitary hormone deficiencies (ACTH (adrenocorticotropic hormone), ADH (antidiuretic hormone), FSH (follicle-stimulating hormone), LH (luteinising hormone), TSH (thyroid-stimulating hormone))

• Known primary hypothyroidism, adrenal insufficiency or hypogonadism (treated or untreated)

• Specific types of growth failure including, but not limited to, known chromosomal abnormalities associated with growth failure and altered sensitivity to growth hormone

• Bone age is advanced over chronological age more than 3 years

• Active malignancy, CNS (central nervous system) trauma, active chemotherapy or radiation therapy for neoplasia

• Prior history of intracranial hypertension

• Hypertrophic cardiomyopathy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dwarfism
• Growth Disorder
• Growth Disorders
• Idiopathic Short Stature

Intervention

Drug:
• somatropin
A weekly dosage of 0.469 mg of somatropin per kg of body weight per week will be injected subcutaneously (under the skin) in the evening in 7 days per week.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Height velocity (Ht-V)		After 6 months of treatment	No
Secondary	Change in Ht-SDS (height standard deviation score)		From day 0 to the end of treatment (month 6)	No
Secondary	Change in IGF related factors: IGF-I (insulin-like growth factor-I)		From day 0 to the end of treatment (month 6)	No
Secondary	Change in IGF related factors: IGFBP-3 (insulin-like growth factor binding protein-3)		From day 0 to the end of treatment (month 6)	No
Secondary	Change for bone age		From day 0 to the end of treatment (month 6)	No
Secondary	Occurrence of Adverse events		From day 0 through month 6	No
Secondary	Ht-V (height velocity)		At the first 6 months and the last 6 months of group A	No

External Links

•   Clinical Trials at Novo Nordisk