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Completed

NCT Number: NCT01778023

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

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.

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Key information

Conditions

Growth Disorder Growth Disorders Idiopathic Short Stature Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

4 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Busan, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somatropin

Drug

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.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Change in Bone Age

    Time frame: After 6 months of treatment.

    Change in bone age from the baseline to 6 months.

  5. Occurrence of Adverse Events

    Time frame: Throughout the trial (12 months)

    AEs were collected throughout the trial in both groups.

  6. 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.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 29, 2013
Registry last updated
Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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