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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00452491 | MAXOMAT ® in the Treatment of Severe Early Onset Intrauterine Growth Retardation on Pre-pubertal Children | PHASE3 | COMPLETED | 306 | — | — | May 1, 1993 | Apr 1, 2010 | Oct 5, 2010 | 1 | France |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| somatropin | DRUG | 0.2 IU/kg/day 7 days per week given sequentially (alternating periods of 6 months of treatment and 6 months of no treatment) for 3 years |
Inclusion Criteria: * Pre-pubertal children of either sex presenting with severe early onset intrauterine growth retardation (I.U.G.R.) * Height Less Than or Equal to -3 SD Exclusion Criteria: * Age less than 3 years The above information is not intended to contain all considerations relevant to...