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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01778023
First received: January 24, 2013
Last updated: August 11, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention Phase
Growth Disorder
Idiopathic Short Stature
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: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Height Velocity (Ht-V) [ Time Frame: After 6 months of treatment ] [ Designated as safety issue: No ]
    Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Ht-V was calculated by Novo Nordisk.


Secondary Outcome Measures:
  • Change in Ht-SDS (Height Standard Deviation Score) [ Time Frame: After 6 months of treatment. ] [ Designated as safety issue: No ]
    Height standard deviation scores (HSDS) were calculated using Korean growth data (reported by the Korea Centre for Disease Control and Prevention). The mean normal range for HSDS is from -2 to +2. Negative scores below -2 indicate a height below normal range, whereas positive scores above +2 indicate a height above normal.

  • Change in IGF Related Factors: IGF-I (Insulin-like Growth Factor-I) [ Time Frame: After 6 months of treatment. ] [ Designated as safety issue: No ]
    IGF-I (insulin-like growth factor-1) was measured at Visit 1 (screening),Visit 3 (3 months ± 7 days ),Visit 4 (6 months ± 7 days),Visit 5 (9 months ± 7 days ) and Visit 6 (12 months ± 7 days ). Change of IGF-I from baseline to 6 months treatment was calculated.

  • Change in IGF Related Factors: IGFBP-3 (Insulin-like Growth Factor Binding Protein-3) [ Time Frame: After 6 months of treatment. ] [ Designated as safety issue: No ]
    IGFBP-3 was measured at Visit 1(screening), Visit 3 (3 months ± 7 days ), Visit 4 (6 months ± 7 days), 5 (9 months ± 7 days ) and 6 ( 12 months ± 7 days). Change of IGFBP-3 from baseline to 6 months treatment were calculated.

  • Change in Bone Age [ Time Frame: After 6 months of treatment. ] [ Designated as safety issue: No ]
    Change in bone age from the baseline to 6 months.

  • Occurrence of Adverse Events [ Time Frame: Throughout the trial (12 months) ] [ Designated as safety issue: No ]
    AEs were collected throughout the trial in both groups.

  • Ht-V (Height Velocity) [ Time Frame: At the first 6 months and the last 6 months in group A ] [ Designated as safety issue: No ]
    Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Three sort of Ht-V was calculated from height data at Visit 2 (day 0), 4 (6 months ± 7 days) and 6 (12 months ± 7 days), as follows: Between Visits 2 and 4, between Visit 4 and 6 and between Visit 2 and 6. Ht-V was calculated by Novo Nordisk. It is the difference between Ht-V for the last 6 months and Ht-V for the first 6 months of treatment. This endpoint was only evaluated for Group A as per the trial protocol.


Enrollment: 54
Study Start Date: January 2013
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hGH:12months treatment 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.
Active Comparator: hGH: 6 month un-treatment + 6 month treatment 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.

  Eligibility

Ages Eligible for Study:   4 Years to 11 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01778023

Locations
Korea, Republic of
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01778023     History of Changes
Other Study ID Numbers: GH-3899  U1111-1125-4790  2015-002613-30 
Study First Received: January 24, 2013
Results First Received: December 17, 2015
Last Updated: August 11, 2016
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Dwarfism
Growth Disorders
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases
Pathologic Processes
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 08, 2016