Clinical Trials Directory

Trials / Completed

CompletedNCT01778023

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

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
54 (actual)
Sponsor
Novo Nordisk A/S · Industry
Sex
All
Age
4 Years – 11 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGsomatropinA 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.

Timeline

Start date
2013-01-17
Primary completion
2014-12-17
Completion
2014-12-17
First posted
2013-01-29
Last updated
2017-06-02
Results posted
2016-10-05

Locations

8 sites across 1 country: South Korea

Source: ClinicalTrials.gov record NCT01778023. Inclusion in this directory is not an endorsement.