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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00396097 | Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature | PHASE3 | COMPLETED | 316 | — | — | Dec 1, 2006 | Aug 1, 2012 | Apr 5, 2016 | 43 | United States |
This was defined as an absolute difference between the 24-month height standard deviation score (SDS) and targeted 24-month height SDS (10th percentile (%), or -1.3 SDS). SDS indicates how similar the participant was to the reference population. These were calculated using 2000 Center for the Disease Control (CDC) growth reference tables (by age and gender).
| Arm | Type | Description |
|---|---|---|
| Standard | ACTIVE_COMPARATOR | Standard daily HGH treatment |
| Formula-based | ACTIVE_COMPARATOR | Formula-based dose regimen |
| Name | Type | Description |
|---|---|---|
| Genotropin | DRUG | Compare daily injections of formula-based HGH treatment to daily injections of standard HGH treatment in subjects with Idiopathic Short Stature over 24 months period followed by an exploratory 24 months period. |
Inclusion Criteria: * Prepubertal children with bone ages between 3 and 10 years of age for males and 3 and 9 years of age for females * Naive to Growth Hormone treatment Exclusion Criteria: * Abnormal karyotype. Small Gestational Age and Skeletal dysplasia.