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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01586494 | A Pharmacokinetic, Tolerability, and Safety Study of ULTRAM ER in Children With Pain | PHASE1 | COMPLETED | 37 | — | — | Oct 1, 2007 | Jun 1, 2009 | Aug 29, 2012 | - | — |
| NCT01586507 | A Study of ULTRAM ER at Two Dose Levels in Adolescents With Pain | PHASE1 | COMPLETED | 38 | — | — | Oct 1, 2007 | Sep 1, 2008 | Aug 29, 2012 | - | — |
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | - |
| Group 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ULTRAM ER | DRUG | One dose of ULTRAM ER that is closest to 2 mg/kg, based on the participant's body weight and adjusting the dose in 25 mg increments. |
Inclusion Criteria: * Confirmed need for control of pain due to injury or nonmalignant disease that does not influence fluid shifts and general drug disposition * Weighs at least 20 kg * Female participants must be premenarchal and in the opinion of the investigator not sexually active * Able to sw...