At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 208 enrolled
Drug / intervention
Genotonorm +2 moredrug
Likely dose
Genotonorm 0.7 IUfrom 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 Two Years Multicentre Study of Genotropin Treatment of Short Prepubertal Children With Intra-Uterine Growth Retardation
In Brief
A Phase 3 clinical trial evaluating Genotonorm for Growth Disorders and Intrauterine Growth Retardation. Completed, enrolled 208 participants across 31 sites.
Detailed Summary
To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGrowth Disorders, Intrauterine Growth Retardation
CountriesFrance
Collaborators--
Timeline
Phase 3CompletedFinished
19931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 1993
Primary CompletionMay 2009
First PostedFeb 2010
TodayJul 2026
First PostedFeb 23, 2010
Enrollment StartJul 1, 1993
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 15.8 yearsPosted 16.4 years ago
Interventions
Genotonormdrug
0.7 IU/kg/week or 0.03 mg/kg/day, daily subcutaneous injection
Genotonormdrug
1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection
Genotonormdrug
1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection Intermittent treatment (6 months with treatment and 6 months without)