At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 62 enrolled
Drug / intervention
Genotropin (somatropin)drug
Likely dose
Genotropin (somatropin) 12 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Long Term Study Of Pnu-180307 For Short Children Born Small For Gestational Age (Sga) Without Epiphyseal Closure (Extension Of The Study 307-met-0021-002)
In Brief
A Phase 4 clinical trial evaluating Genotropin (somatropin) for Short Stature Born Small for Gestational Age (SGA). Completed, enrolled 62 participants across 19 sites.
Detailed Summary
To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--
Timeline
Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2002
First PostedMay 2013
Primary CompletionAug 2015
TodayJul 2026
First PostedMay 22, 2013
Enrollment StartOct 1, 2002
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 12.8 yearsPosted 13.1 years ago
Interventions
Genotropin (somatropin)drug
Genotropin(somatoropin) 12 mg, Genotropin(somatropin) will be given at a dose of 0.067 mg/kg/day or 0.033 mg/kg/day to all participating patients