CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 98 enrolled
Drug / intervention
somatropin +1 moredrug
Likely dose
NN-220 0.033 mg/kg/day or 0.067 mg/kg/day by subcutaneous injectionAI-extracted
Key inclusion· 4
  • ✓Born small for gestational age with birth weight and birth length below 10th percentile, AND either birth length ≤-2.0 SDS or birth weight ≤-2.0 SDS for gestational age
  • ✓Current height at or below -2.0 SDS for chronological age
  • ✓Normal growth hormone production with peak GH level >10 ng/mL on provocation test
  • ✓For extension phase: chronological age 4-11 years for boys, 4-10 years for girls
Key exclusion· 3
  • ✕Diabetes mellitus
  • ✕Current or prior malignancy
  • ✕Several undisclosed medical conditions

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00184717
NCT00184717Phase 3Completed
CompareCT.gov

GHLIQUID-1516: A 104-week, Multi-centre, Randomised, Double-blind, Parallel-group, no Treatment Controlled (Open-label) Trial Investigating the Efficacy and Safety of Two Doses of NN-220 in Subjects With Short Stature Born Small for Gestational Age / GHLIQUID-1517: A Long-term, Multi-centre, Randomised, Controlled, Double-blind, Parallel-group Trial, Investigating the Efficacy and Safety of Two Doses of NN-220 in Subjects With Short Stature Born Small for Gestational Age

Novo Nordisk A/S·interventional·Posted Sep 16, 2005·Updated Jul 7, 2017

In Brief

A Phase 3 clinical trial evaluating somatropin for Foetal Growth Problem and Small for Gestational Age. Completed, enrolled 98 participants across 1 site.

Detailed Summary

This study is conducted in Japan. The aim of this trial is to assess the efficacy and safety of somatropin in children born small for gestational age (SGA) in Japan. In the main period, subjects will receive either active treatment for 104 weeks (two dosing regimens) or no treatment for 52 weeks followed by an extension period where subjects who received active treatment for 104 weeks (two years) will continue with the same treatment for further 156 weeks (three years) while those subjects who received no treatment for 52 weeks (one year) will be randomised to receive two dosing regimens for 208 weeks (four years). In total, subjects participate in trial for 260 weeks (five years). Main period is registered internally at Novo Nordisk as GHLIQUID-1516 while the extension period is registered as GHLIQUID-1517.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFoetal Growth Problem, Small for Gestational Age
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartAug 18, 2004
Primary CompletionMar 29, 2006
Study CompletionDec 28, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 20.8 years ago

Interventions

somatropindrug

0.033 mg/kg/day of NN-220 for s.c. injection in cartridge

somatropindrug

0.067 mg/kg/day of NN-220 for s.c. injection in cartridge