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Caffeine · 2 trials · 2 indications
Pain intensity scale is the Numerical Rating Scale measured from 0 to 10, where 0 indicates no pain and 10 means the wors pain imaginable. Pain intensity Difference (PID) is calculated by subtracting the pain intensity at different time points in the post-dose time point from the pain intensity at baseline. The summed pain intensity difference (SPID) is to be calculated by multiplying the PID score at each post dose time point by the duration (in hours) since the preceding time point and then summing the values over the relevant time period. For SPID (0-8), eight PIDs are summed up, which is minimally 0, if there is no pain relief or maximally 80, if there is very strong pain and significant pain relief.
Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. Sum of Pain Intensity Differences (SPIDs) was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 8 hours ranges from -80 to 80. A higher value indicates a better pain reduction.
| Arm | Type | Description |
|---|---|---|
| Naproxen sodium/caffeine - Dose 1 | EXPERIMENTAL | Participants will receive a single dose of one tablet of naproxen sodium/caffeine plus one tablet of placebo after extraction of third molars. |
| Naproxen sodium/caffeine - Dose 2 | EXPERIMENTAL | Participants will receive a single dose of two tablets of naproxen sodium/caffeine after extraction of third molars. |
| Naproxen sodium | EXPERIMENTAL | Participants will receive a single dose of one tablet of naproxen sodium plus one tablet of placebo after extraction of third molars. |
| Caffeine | EXPERIMENTAL | Participants will receive a single dose of two tablets of caffeine after extraction of third molars. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a single dose of two tablets of matching placebo after extraction of third molars. |
| Naproxen sodium/caffeine - Dose 3 | EXPERIMENTAL | Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ medium low dose) plus one tablet of placebo after extraction of third molars |
| Naproxen sodium/caffeine - Dose 4 | EXPERIMENTAL | Participants received a single dose of one tablet of naproxen sodium/caffeine (low dose/ low dose) plus one tablet of placebo after extraction of third molars |
| Name | Type | Description |
|---|---|---|
| Naproxen sodium and caffeine (BAY2880376) | DRUG | Tablet, oral use, single dose |
| Naproxen sodium (Aleve) | DRUG | Tablet, oral use, single dose |
| Caffeine | DRUG | Tablet, oral use, single dose |
| Placebo | DRUG | Tablet, oral use, single dose |
| Naproxen sodium/Caffeine (BAY2880376) | DRUG | Tablet, oral, single dose |
Inclusion Criteria: * Healthy, ambulatory, male or female volunteers 16 years of age or older; * Body mass index (BMI) 18.5 to 35.0 kg/m\^2 inclusive as measured by the National Institutes of Health (NIH) BMI Calculator; * Participants will undergo surgical extraction of three or four third molars,...
Caffeine is being studied as part of a fixed-dose combination tablet with naproxen sodium for the relief of moderate to severe pain after dental surgeries, including wisdom tooth removal. It is being evaluated in clinical trials for postoperative dental pain and postoperative pain.
Caffeine is being developed by Bayer AG, a pharmaceutical company traded on the OTC market under the ticker BAYRY. The company is conducting clinical trials to evaluate caffeine in combination with naproxen sodium for postoperative pain relief.
Caffeine is in clinical development, with a completed Phase 2 trial and a completed Phase 3 trial. It is an investigational combination product and has not been approved for the studied indications based on the available data.
Caffeine is a small molecule that acts as a central nervous system stimulant. In the studied combination, it is used as an adjuvant to enhance the analgesic effect of naproxen sodium, a nonsteroidal anti-inflammatory drug, for postoperative pain relief.
Caffeine has been studied in two completed clinical trials: NCT04132336, a Phase 2 dose-finding study in patients with moderate to severe pain after wisdom tooth removal, and NCT05485805, a Phase 3 study comparing a fixed-dose combination of naproxen sodium and caffeine to its single ingredients and placebo after dental surgeries.
Caffeine is being studied as part of a fixed-dose combination tablet with naproxen sodium. The combination is being evaluated for postoperative dental pain, with the caffeine component intended to enhance pain relief compared to naproxen sodium alone.