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ULTRAM · 2 trials · 1 indication
| 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...
ULTRAM is a small molecule drug being developed for the treatment of pain. It is currently in Phase 1 clinical development as an investigational product and is not yet approved by the FDA.
ULTRAM is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ.
ULTRAM is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, with a total of 75 participants enrolled.
ULTRAM has completed two Phase 1 clinical trials. The first, NCT01586494, studied ULTRAM ER in children aged 7 years and older with pain. The second, NCT01586507, studied ULTRAM ER at two dose levels in adolescents aged 12 years and older with pain.
ULTRAM ER is the extended-release formulation of ULTRAM. Both names refer to the same drug product, with ULTRAM ER being the specific formulation studied in the clinical trials for pain.