Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00627523 | Genotropin Treatment In Very Young Children Born Small For Gestational Age | PHASE3 | COMPLETED | 43 | — | — | Feb 1, 2008 | Dec 1, 2013 | Nov 4, 2014 | 17 | Belgium, Czechia +7 |
Height SDS was calculated at the relevant visit by means of the following formula: Height SDS = (participant height) - (normal height)/normal height standard deviation. Where participant height refers to the participant's height at the relevant visit, and normal height and the normal height standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for height SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | The active treatment arm |
| Control | EXPERIMENTAL | Control |
| Name | Type | Description |
|---|---|---|
| Genotropin (PN-180,307) Somatropin | DRUG | Injectable Genotropin |
| Control-no treatment | DRUG | Control-no treatment |
Inclusion Criteria: Caucasian male or female subjects aged between 19-29 months at Screening Visit 1. Born SGA (birth length and/or weight \<-2 SD for gestational age, using country-specific standards). Height below -2.5 SD at screening (19-29 months of age). At least one measurement of length be...