Trial intelligence / Profile preview

Norditropin in Idiopathic Short Stature

NCT01778023Phase 3

Key facts

Status: Completed
Start: Jan 2013
Primary completion: Dec 2014
Countries: 1
Sponsor: Novo Nordisk
Modality: Hormone, rProtein (Recombinant Protein), Biologic

Drugs: somatropin
Conditions: Idiopathic Short Stature (ISS)

Overview

Phase 3, randomised, open-label trial of somatropin in Idiopathic Short Stature (ISS) (2 arms), sponsored by Novo Nordisk. Primary endpoint: Height Velocity (Ht-V) at 6 months. Started Jan 2013; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

hGH:12months treatment
Norditropin for 12 months
hGH: 6 month un-treatment + 6 month treatment
No treatment for 6 months, then Norditropin for 6 months

Who it enrols

Pre-pubertal children (males 4-11, females 4-9) with idiopathic short stature, height < 3rd percentile, bone age <= 12 years, and normal GH levels (>10 ng/mL).

Endpoints

Primary

Height Velocity (Ht-V)6 months

Secondary

Change in Height Standard Deviation Score (Ht-SDS)6 months
Change in Insulin-like Growth Factor-I (IGF-I)6 months
Change in Insulin-like Growth Factor Binding Protein-3 (IGFBP-3)6 months
Change in Bone Age6 months
Occurrence of Adverse Events12 months
Height Velocity (Ht-V) in Group A12 months

Results

Primary endpoints met

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