A 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

• Conditions: Idiopathic short stature; MedDRA version: 19.0Level: LLTClassification code 10066333Term: Idiopathic short statureSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2015-002613-30-Outside-EU/EEA
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-25
• Last Update Posted: 2 May 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 54

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 < 4 mL in males
· Height below 3 percentile†
· Epiphyses confirmed as open in patients =10 years of age
· Growth hormone level above 10 ng/mL following a stimulation test (test result within 6 months from screening can be used)
· Bone age = 12 years
†:According to the 2007 Korean National growth chart (see Appendix D)
Are the trial subjects under 18? yes
Number of subjects for this age range: 54
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

· Known presence of one or more pituitary hormone deficiencies (ACTH, ADH, FSH, LH, TSH)
· 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 (inclusive)
· Active malignancy, CNS trauma, active chemotherapy or radiation therapy for neoplasia within 5 years prior to screening (Visit 1)
· Prior history of intracranial hypertension
· Hypertrophic cardiomyopathy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified