At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 278 enrolled
Drug / intervention
Omnitropedrug
Likely dose
Omnitrope 0.0351 mg/kgfrom 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 Phase IV Multicentre Study on the Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)
In Brief
A Phase 4 clinical trial evaluating Omnitrope for Small for Gestational Age. Completed, enrolled 278 participants across 31 sites in 7 countries.
Detailed Summary
This study is performed to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (SGA).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall for Gestational Age
CountriesBelgium, Czechia, Georgia, Germany, Hungary, Poland, Romania
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2007
Enrollment StartFeb 2008
Primary CompletionMar 2022
TodayJul 2026
First PostedOct 2, 2007
Enrollment StartFeb 6, 2008
Primary CompletionMar 25, 2022
TodayJul 2, 2026
Enrollment to primary: 14.1 yearsPosted 18.8 years ago
Interventions
Omnitropedrug
All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits.