At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 224 enrolled
Drug / intervention
MOD-4023 +1 moredrug
Likely dose
Not stated in 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.
A Phase 3, Open-label, Randomized, Multicenter, 12 Months, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin - Therapy in Pre-pubertal Children With Growth Hormone Deficiency
In Brief
A Phase 3 clinical trial evaluating MOD-4023 and Somatropin for Pediatric Growth Hormone Deficiency. Completed, enrolled 224 participants across 81 sites in 20 countries.
Detailed Summary
This is an open-label, randomized, multicenter, efficacy and safety study of weekly MOD-4023 compared to daily Genotropin therapy in pre-pubertal children with growth hormone deficiency.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPediatric Growth Hormone Deficiency
CountriesArgentina, Australia, Belarus, Bulgaria, Canada, Colombia, Georgia, Greece, India, Israel, Mexico, New Zealand, Poland, Russia, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 2016
Enrollment StartDec 2016
Primary CompletionAug 2019
Study CompletionMay 2024
TodayJul 2026
First PostedNov 18, 2016
Enrollment StartDec 1, 2016
Primary CompletionAug 1, 2019
Study CompletionMay 1, 2024
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.6 years ago
Interventions
MOD-4023drug
Once weekly subcutaneous injection using pre-filled pen device.
Somatropindrug
Once daily subcutaneous injection of Genotropin using pre-filled pen device.