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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:
ClinicalTrials.gov Identifier:
NCT01778023
First Posted: January 29, 2013
Last Update Posted: June 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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. ]
    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. ]
    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. ]
    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. ]
    Change in bone age from the baseline to 6 months.

  • Occurrence of Adverse Events [ Time Frame: Throughout the trial (12 months) ]
    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 ]
    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
Actual Study Start Date: January 17, 2013
Study Completion Date: December 17, 2014
Primary Completion Date: December 17, 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

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Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778023


Locations
Korea, Republic of
Novo Nordisk Investigational Site
Busan, Korea, Republic of, 614-735
Novo Nordisk Investigational Site
Daegu, Korea, Republic of, 700-721
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 02841
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 03722
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 137-701
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 138-736
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 150-713
Novo Nordisk Investigational Site
Suwon, Korea, Republic of, 443-721
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Safety and Efficacy Evaluation of Human Growth Hormone (GH) Therapy in Patients with Idiopathic Short Stature (ISS) in Korea - a Randomized Controlled Trial; Min Ho Jung, Byung-Kyu Suh, Cheol Woo Ko et al.; 028-042-GH-Pediatrics (posters) ENDO meeting 2016, Boston Massachusetts

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01778023     History of Changes
Other Study ID Numbers: GH-3899
U1111-1125-4790 ( Other Identifier: WHO )
2015-002613-30 ( EudraCT Number )
First Submitted: January 24, 2013
First Posted: January 29, 2013
Results First Submitted: December 17, 2015
Results First Posted: October 5, 2016
Last Update Posted: June 2, 2017
Last Verified: May 2017

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