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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01778023
First received: January 24, 2013
Last updated: February 5, 2014
Last verified: February 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:
  • Change in height velocity (Ht-V) [ Time Frame: From day 0 to the end of treatment (month 6) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Ht-SDS (height standard deviation score) [ Time Frame: From day 0 to the end of treatment (month 6) ] [ Designated as safety issue: No ]
  • Change in IGF related factors: IGF-I (insulin-like growth factor-I) [ Time Frame: From day 0 to the end of treatment (month 6) ] [ Designated as safety issue: No ]
  • Change in IGF related factors: IGFBP-3 (insulin-like growth factor binding protein-3) [ Time Frame: From day 0 to the end of treatment (month 6) ] [ Designated as safety issue: No ]
  • Change for bone age [ Time Frame: From day 0 to the end of treatment (month 6) ] [ Designated as safety issue: No ]
  • Occurrence of Adverse events [ Time Frame: From day 0 through month 6 ] [ Designated as safety issue: No ]
  • Ht-V (height velocity) [ Time Frame: At the first 6 months and the last 6 months of group A ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (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

Ages Eligible for Study:   4 Years to 11 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778023

Locations
Korea, Republic of
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01778023     History of Changes
Other Study ID Numbers: GH-3899, U1111-1125-4790
Study First Received: January 24, 2013
Last Updated: February 5, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Dwarfism
Growth Disorders
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2014