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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01778023
Other study ID # GH-3899
Secondary ID U1111-1125-47902
Status Completed
Phase Phase 3
First received January 24, 2013
Last updated November 27, 2015
Start date January 2013
Est. completion date December 2014

Study information

Verified date November 2015
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 4 Years to 11 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Height velocity (Ht-V) After 6 months of treatment No
Secondary Change in Ht-SDS (height standard deviation score) From day 0 to the end of treatment (month 6) No
Secondary Change in IGF related factors: IGF-I (insulin-like growth factor-I) From day 0 to the end of treatment (month 6) No
Secondary Change in IGF related factors: IGFBP-3 (insulin-like growth factor binding protein-3) From day 0 to the end of treatment (month 6) No
Secondary Change for bone age From day 0 to the end of treatment (month 6) No
Secondary Occurrence of Adverse events From day 0 through month 6 No
Secondary Ht-V (height velocity) At the first 6 months and the last 6 months of group A No
See also
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Completed NCT01246219 - Short Stature Related Distress Phase 4
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Completed NCT00710307 - Epidemiology Study on Insulin-like Growth Factor-1 in Children With Idiopathic Short Stature (EPIGROW Study)
Completed NCT01248416 - Aromatase Inhibitors, Alone And In Combination With Growth Hormone In Adolescent Boys With Idiopathic Short Stature Phase 3
Completed NCT01504802 - Pharmacodynamics of CNP During Growth Hormone Treatment N/A
Completed NCT00488124 - Growth Response in Short Children Suffering From a Disease With Growth Retardation and Treated With Somatropin Phase 2
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Recruiting NCT06309979 - A Study to Assess Growth in Children With Idiopathic Short Stature
Terminated NCT00121875 - Study to Identify Markers of Insulin Resistance During Growth Hormone Treatment for Short Stature Phase 4
Not yet recruiting NCT05858606 - Multidisciplinary Evaluation and a Genome-wide Analysis in a Cohort of Idiopathic Short Stature Patients N/A
Active, not recruiting NCT04020913 - Skeletal Muscle Effects of GH in Boys
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Recruiting NCT02973061 - The Impact of the Use of Recombinant Human Growth Hormone on ADHD Characteristics in Children and Adolescents
Recruiting NCT01604395 - Long-term Safety and Effectiveness of Growth Hormone With GHD, TS, CRF, SGA , ISS and PWS in Children
Active, not recruiting NCT00840944 - A 4 Year Combination Therapy of Growth Hormone and (GnRH) Agonist in Children With a Short Predicted Height Phase 4
Completed NCT01070173 - Ghrelin Levels in Children With Poor Growth N/A
Completed NCT01543867 - Safety and Efficacy of Long-term Somatropin Treatment in Children N/A
Recruiting NCT04798690 - Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature