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Also known as ULTRAM ER
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 used for the treatment of pain. It is a small molecule therapeutic in the pain therapeutic area. Clinical development has focused on pain in pediatric and adolescent patients, including studies in children and adolescents with pain.
ULTRAM is developed by Johnson & Johnson, which trades under the ticker JNJ. Johnson & Johnson is the company associated with the ULTRAM and ULTRAM ER development programs.
ULTRAM is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 program consists of two completed trials, with no active trials currently listed.
ULTRAM has been studied in two completed Phase 1 trials. NCT01586507 evaluated ULTRAM ER at two dose levels in adolescents with pain, enrolling 38 patients. NCT01586494 was a pharmacokinetic, tolerability, and safety study of ULTRAM ER in children with pain, enrolling 37 patients.
Yes, ULTRAM ER is an alternative name for ULTRAM. Both names refer to the same Johnson & Johnson small molecule pain program, and the completed Phase 1 trials in adolescents and children were conducted under the ULTRAM ER designation.