Approval Probability
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Adjusted LOA
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acetaminophen Caplet · 1 trial · 1 indication
Minutes until confirmed first perceptible pain relief are achieved. Stopwatch is started after the subject takes the study medication. The subject is instructed to stop the stopwatch when they first begin to feel any pain relief. The first perceptible pain relief is confirmed if the subject also stopped the second stopwatch indicating meaningful pain relief.
| Arm | Type | Description |
|---|---|---|
| Test acetaminophen | EXPERIMENTAL | acetaminophen tablet and placebo caplet and placebo liquid-filled capsule |
| Commercial acetaminophen | ACTIVE_COMPARATOR | acetaminophen caplet and placebo tablet and placebo liquid-filled capsule |
| Commercial ibuprofen | ACTIVE_COMPARATOR | ibuprofen liquid-filled capsule and placebo tablet and placebo caplet |
| Placebo | PLACEBO_COMPARATOR | Placebo tablet and placebo caplet and placebo liquid-filled capsule |
| Name | Type | Description |
|---|---|---|
| acetaminophen Tablet | DRUG | 2 test acetaminophen 500 mg tablets |
| acetaminophen Caplet | DRUG | 2 commercial acetaminophen 500 mg caplets |
| ibuprofen Liquid-filled capsule | DRUG | 2 commercial ibuprofen 200 mg Liquid-filled capsules |
| Placebo Tablet | DRUG | 2 placebo tablets |
| Placebo Caplet | DRUG | 2 placebo caplets |
| Placebo Liquid-filled capsule | DRUG | 2 placebo Liquid-filled capsules |
Inclusion Criteria: 1. 17 years to 50 years old 2. Weight 100 lbs or greater with a body mass index (BMI) 18-30 inclusive 3. Dental extraction of three or four molars 4. Experience moderate to severe pain after extraction of third molars 5. Females of childbearing age must be willing to use accepta...
Acetaminophen Caplet is being studied for the treatment of post operative dental pain. Johnson & Johnson is developing it in this pain indication, and the clinical program has evaluated it in a Phase 3 trial in the United States. It is a small molecule therapeutic candidate rather than an approved product for this use.
Acetaminophen Caplet targets PTGS2, PTGS1, FAAH and TRPV1. It is classified as an inhibitor, meaning it acts by inhibiting these molecular targets. PTGS1 and PTGS2 are cyclooxygenase enzymes, FAAH is fatty acid amide hydrolase, and TRPV1 is a transient receptor potential ion channel involved in pain signaling.
Johnson & Johnson, which trades under the ticker JNJ, is the developer of acetaminophen Caplet. The company is responsible for the clinical program evaluating the drug candidate in post operative dental pain.
Acetaminophen Caplet has been evaluated in a Phase 3 clinical trial. That study is completed, and there are currently no active trials of this candidate. It is an investigational product in clinical development and has not been established as an approved treatment for post operative dental pain.
Acetaminophen Caplet has been studied in one clinical trial, NCT02735122, titled Study of Acetaminophen (ACM) in Post-operative Dental Pain. The Phase 3 trial was completed, enrolled 420 participants, was randomized, double blind and placebo controlled, and was conducted in the United States.