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

May 4, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 614-735
        • Novo Nordisk Investigational Site
      • Daegu, Korea, Republic of, 700-721
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 03722
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 02841
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 137-701
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 150-713
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 138-736
        • Novo Nordisk Investigational Site
      • Suwon, Korea, Republic of, 443-721
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After 6 months of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After 6 months of treatment.
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.
After 6 months of treatment.
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.
After 6 months of treatment.
Change in Bone Age
Time Frame: After 6 months of treatment.
Change in bone age from the baseline to 6 months.
After 6 months of treatment.
Occurrence of Adverse Events
Time Frame: Throughout the trial (12 months)
AEs were collected throughout the trial in both groups.
Throughout the trial (12 months)
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.
At the first 6 months and the last 6 months in group A

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2013

Primary Completion (Actual)

December 17, 2014

Study Completion (Actual)

December 17, 2014

Study Registration Dates

First Submitted

January 24, 2013

First Submitted That Met QC Criteria

January 24, 2013

First Posted (Estimate)

January 29, 2013

Study Record Updates

Last Update Posted (Actual)

June 2, 2017

Last Update Submitted That Met QC Criteria

May 4, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GH-3899
  • U1111-1125-4790 (Other Identifier: WHO)
  • 2015-002613-30 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Growth Disorder

Clinical Trials on somatropin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe