Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ibuprofen Immediate Release/ Caplet · 1 trial · 1 indication
Participants as correct selectors included all participants who selected Ibuprofen 600 mg IR/ER medication with the last episode of pain of \>=6 hours, if left untreated. Participants as correct de-selectors included all participants who either selected Ibuprofen 200 mg or selected 'neither' with a typical pain duration of less than (\<) 6 hours, if left untreated.
Participants as correct selectors included all participants who selected Ibuprofen 600 mg IR/ER medication with the last episode of pain of \>=6 hours, if left untreated. Participants as correct de-selectors included all participants who either selected Ibuprofen 200 mg or selected 'neither' with a typical pain duration of \<6 hours, if left untreated. Participants were classified as "missed opportunity" cases when they selected the Ibuprofen 200 mg IR medication with their typical duration of pain \>=6 hours.
Percentage of participants with correct selection of Ibuprofen 600 mg IR/ER medication with a typical duration of pain \<6 hours were reported in this outcome measure.
Percentage of participants with selection of Ibuprofen 200 mg IR medication with a typical duration of pain \>=6 hours were reported in this outcome measure. These participants were classified as ''missed opportunity'' cases.
Percentage of participants with the use of study medication for \>10 days with an average daily dose of \>1600 mg were reported in this outcome measure.
Percentage of participants who used the study medication for \<=10 days and used more than 20 tablets with an average daily dose of \>1600 mg were reported in this outcome measure.
| Arm | Type | Description |
|---|---|---|
| Ibuprofen 600 mg Immediate Release/Extended Release Caplet | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Ibuprofen 600 mg Immediate Release/Extended Release Caplet | DRUG | Ibuprofen 600 mg Immediate Release/Extended Release Caplet to be adminstered orally (i.e., one caplet every 12 hours, not to exceed 2 caplets per day) for pain. |
Inclusion Criteria: * at least 12 years of age * use of at least 5 doses per month of over-the-counter pain relievers over the past 3 months * provide written informed consent (subjects 12-\<18 years of age provide a written assent and parent/guardian will provide written informed consent) * capabl...
Ibuprofen Immediate Release/Caplet is used for analgesia, the relief of pain. It is a small molecule being developed by Pfizer, Inc. under the ticker PFE. The asset is in Phase 3 development, and its clinical program has focused on pain relief in an analgesia setting.
Ibuprofen Immediate Release/Caplet targets PTGS2 and PTGS1, also known as cyclooxygenase-2 and cyclooxygenase-1. It acts as an inhibitor of these enzymes. This target class places it among nonsteroidal anti-inflammatory drugs that reduce prostaglandin production linked to pain and inflammation.
Pfizer, Inc. is the developer of Ibuprofen Immediate Release/Caplet. The company trades under the ticker PFE. Pfizer has advanced the asset into Phase 3 clinical development for analgesia, with one completed trial listed in the program.
Ibuprofen Immediate Release/Caplet is in Phase 3 development. It is an investigational asset, and the program includes one completed Phase 3 trial. No active trials are currently listed for this specific caplet formulation.
Ibuprofen Immediate Release/Caplet has been studied in the Phase 3 trial NCT01789606, titled Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet. The trial enrolled 1,083 participants, was conducted in the United States, and is now completed.