At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 56 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.
Safety and Dose Finding Study of Different MOD-4023 Dose Levels Compared to Daily r-hGH Therapy in Pre-pubertal Growth Hormone Deficient Children
In Brief
A Phase 2 clinical trial evaluating MOD-4023 and Somatropin for Pediatric Growth Hormone Deficiency. Completed, enrolled 56 participants across 4 sites in 3 countries.
Detailed Summary
This is a phase II, open label, active-controlled, randomized safety and dose finding study of different MOD-4023 dose levels compared to daily r-hGH therapy in pre-pubertal growth hormone deficient children.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPediatric Growth Hormone Deficiency
CountriesGreece, Hungary, Slovakia
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2012
First PostedMay 2012
Primary CompletionJul 2015
TodayJul 2026
First PostedMay 7, 2012
Enrollment StartFeb 1, 2012
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 14.2 years ago
Interventions
MOD-4023drug
Once weekly subcutaneous injection
Somatropindrug
Once daily subcutaneous injection of Genotropin