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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-17

Study Completion Date

2014-12-17

Brief Summary

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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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Detailed Description

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Conditions

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Growth Disorder Idiopathic Short Stature

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hGH:12months treatment

Group Type EXPERIMENTAL

somatropin

Intervention Type 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.

hGH: 6 month un-treatment + 6 month treatment

Group Type ACTIVE_COMPARATOR

somatropin

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No