Trial · NCT05485805
A Study to Learn How Well a Single Dose of the Study Treatment Naproxen Sodium and Caffeine Combined in One Tablet (Fixed-dose Combination) Works to Relieve Pain After Dental Surgeries Compared to the Single Ingredients and to Placebo
NCT05485805, Phase 3, Completed, Bayer; results first posted 2025-03-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Learn How Well a Single Dose of the Study Treatment Naproxen Sodium and Caffeine Combined in One Tablet (Fixed-dose Combination) Works to Relieve Pain After Dental Surgeries Compared to the Single Ingredients and to Placebo. Trials, record NCT05485805. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05485805
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Learn How Well a Single Dose of the Study Treatment Naproxen Sodium and Caffeine Combined in One Tablet (Fixed-dose Combination) Works to Relieve Pain After Dental Surgeries Compared to the Single Ingredients and to Placebo
- NCT number
- NCT05485805
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 541 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Postoperative Dental Pain
- Interventions
- Naproxen sodium and caffeine (BAY2880376), Naproxen sodium (Aleve), Caffeine, Placebo
- First posted
- 2022-08-03
- Last updated
- 2025-03-25
- Other registries' IDs
- eudract:2022-003274-22
- Results first posted
- 2025-03-25
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sum of Pain Intensity Difference (SPID) Over 8 Hours Post-dose | Up to 8 hours post-dose | 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. |
| Secondary | Sum of Pain Intensity Differences From 0 to 2, 4, 6, 12 and 24 Hours Post-dose | from 0 to 2, 4, 6, 12 and 24 hours post-dose | 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-i), i PIDs are summed up, which minimally is 0, if there is no pain relief or maximally i\*10, if there is very strong pain and significant pain relief. |
| Secondary | Total Pain Relief (TOTPAR) From 0 to 2, 4, 6, 8, 12 and 24 Hours Post-dose | up to 24 hours post-dose | Total Pain Relief (TOTPAR) is a cumulative measure that evaluates the overall pain relief over a specific time frame from 0-2,0-4,0-6,0-8,0-12 and 0-24 following drug administration. It is calculated by multiplying the pain relief score from the categorical pain relief scale at each time post-dose time by multiplying the duration (in hours) since the preceding time point and then adding these values. Categorical Pain Relief Scale measure the degree of pain relief using a scale from 0 to 4, in which 0 is no relief, 1 a little relief, 2 some relief, 3 a lot of relief and 4 complete relief. Higher values of TOTPAR indicates better pain relief and suggest that the investigational product provided consistence and meaningful pain relief over the period. Low TOTPAR values indicates minimal pain relief or short-lasting efficacy. |
| Secondary | Time to First Use of Rescue Medication | Up to 24 hours post-dose | |
| Secondary | The Cumulative Proportion of Participants Taking Rescue Medication Over the 24 Hour Period | Up to 24 hours post-dose | |
| Secondary | Time to First Perceptible Relief Measured by a Stopwatch | Up to 24 hours post-dose | |
| Secondary | Time to Meaningful Relief Measured by a Stopwatch | Up to 24 hours post-dose | meaningful relief is the point when the participant perceives their pain as significant and meaningful to them using the double-stopwatched method that allows to differentiate between the onset of the analgesic effect (first perceptible pain relief) and the onset of meaningful pain relief |
| Secondary | Time to First Perceptible Relief Confirmed by Meaningful Relief Defined as the Time to Perceptible Pain Relief | Up to 24 hours post-dose | |
| Secondary | Pain Intensity Difference (PID) | up to 24 hours post-dose | Pain Intensity Difference (PID) is the change of pain intensity at a specific time point compared to baseline using the Numerical Rating Scale from 0 to 10. Value of 0 score means no pain and 10 score result means the worst possible pain. For each post-dose time point, pain intensity differences will be derived by subtracting the pain intensity at the post-dose time point from the baseline intensity score. Positive PID values indicate pain relief (reduction in pain intensity), while negative or small PID values suggest little or no reduction in pain intensity |
| Secondary | Pain Relief Score | Up to 24 hours post-dose | Pain Relief Score (PRS): 0 = No Relief; 1 = A Little Relief; 2 = Some Relief; 3 = A Lot of Relief; 4 = Complete Relief. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sum of Pain Intensity Difference (SPID) Over 8 Hours Post-dose | Up to 8 hours post-dose | Points on scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Sum of Pain Intensity Differences From 0 to 2, 4, 6, 12 and 24 Hours Post-dose | from 0 to 2, 4, 6, 12 and 24 hours post-dose | Points on scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Total Pain Relief (TOTPAR) From 0 to 2, 4, 6, 8, 12 and 24 Hours Post-dose | up to 24 hours post-dose | Points on scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Time to First Use of Rescue Medication | Up to 24 hours post-dose | Hours | MEDIAN | |
| SECONDARY | The Cumulative Proportion of Participants Taking Rescue Medication Over the 24 Hour Period | Up to 24 hours post-dose | proportion | NUMBER | |
| SECONDARY | Time to First Perceptible Relief Measured by a Stopwatch | Up to 24 hours post-dose | Hours | MEDIAN | |
| SECONDARY | Time to Meaningful Relief Measured by a Stopwatch | Up to 24 hours post-dose | Hours | MEDIAN | |
| SECONDARY | Time to First Perceptible Relief Confirmed by Meaningful Relief Defined as the Time to Perceptible Pain Relief | Up to 24 hours post-dose | Hours | MEDIAN | |
| SECONDARY | Pain Intensity Difference (PID) | up to 24 hours post-dose | Points on scale | MEAN | |
| SECONDARY | Pain Relief Score | Up to 24 hours post-dose | Points on scale | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group560
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sum of Pain Intensity Difference (SPID) Over 8 Hours Post-dose | Naproxen Sodium/ Caffeine 220/65 mg | 31.293 | Standard Error 1.441 | Points on scale | |
| Sum of Pain Intensity Difference (SPID) Over 8 Hours Post-dose | Naproxen Sodium/Caffeine 2x220/65 mg | 37.242 | Standard Error 1.436 | Points on scale | |
| Sum of Pain Intensity Difference (SPID) Over 8 Hours Post-dose | Naproxen Sodium 220 mg | 31.082 | Standard Error 1.443 | Points on scale | |
| Sum of Pain Intensity Difference (SPID) Over 8 Hours Post-dose | Caffeine 100 mg | 5.146 | Standard Error 2.470 | Points on scale | |
| Sum of Pain Intensity Difference (SPID) Over 8 Hours Post-dose | Placebo | 8.622 | Standard Error 2.521 | Points on scale | |
| Sum of Pain Intensity Differences From 0 to 2, 4, 6, 12 and 24 Hours Post-dose | Naproxen Sodium/ Caffeine 220/65 mg | 0-2 hours post-dose | 7.347 | Standard Error 0.341 | Points on scale |
| Sum of Pain Intensity Differences From 0 to 2, 4, 6, 12 and 24 Hours Post-dose | Naproxen Sodium/Caffeine 2x220/65 mg | 0-2 hours post-dose | 8.950 | Standard Error 0.340 | Points on scale |
| Sum of Pain Intensity Differences From 0 to 2, 4, 6, 12 and 24 Hours Post-dose | Naproxen Sodium 220 mg | 0-2 hours post-dose | 7.973 | Standard Error 0.341 | Points on scale |
| Sum of Pain Intensity Differences From 0 to 2, 4, 6, 12 and 24 Hours Post-dose | Caffeine 100 mg | 0-2 hours post-dose | 1.876 | Standard Error 0.585 | Points on scale |
| Sum of Pain Intensity Differences From 0 to 2, 4, 6, 12 and 24 Hours Post-dose | Placebo | 0-2 hours post-dose | 1.567 | Standard Error 0.597 | Points on scale |
1 to 10 of 560Source ClinicalTrials.gov
See all 560 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Naproxen Sodium/ Caffeine 220/65 mg | 147 | |
| Overall Study | STARTED | Naproxen Sodium/Caffeine 2x220/65 mg | 148 | |
| Overall Study | STARTED | Naproxen Sodium 220 mg | 147 | |
| Overall Study | STARTED | Caffeine 100 mg | 50 | |
| Overall Study | STARTED | Placebo | 49 | |
| Overall Study | COMPLETED | Naproxen Sodium/ Caffeine 220/65 mg | 145 | |
| Overall Study | COMPLETED | Naproxen Sodium/Caffeine 2x220/65 mg | 144 | |
| Overall Study | COMPLETED | Naproxen Sodium 220 mg | 142 | |
| Overall Study | COMPLETED | Caffeine 100 mg | 49 | |
| Overall Study | COMPLETED | Placebo | 47 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events140
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Naproxen Sodium/ Caffeine 220/65 mg | 0 | 147 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Naproxen Sodium/Caffeine 2x220/65 mg | 1 | 148 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 0 | 49 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Caffeine 100 mg | 0 | 50 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Naproxen Sodium 220 mg | 0 | 147 | 0 |
| other | Alveolar osteitis | Infections and infestations | Naproxen Sodium/ Caffeine 220/65 mg | 4 | 147 | 4 |
| other | Alveolar osteitis | Infections and infestations | Naproxen Sodium/Caffeine 2x220/65 mg | 0 | 148 | 0 |
| other | Alveolar osteitis | Infections and infestations | Placebo | 0 | 49 | 0 |
| other | Alveolar osteitis | Infections and infestations | Caffeine 100 mg | 0 | 50 | 0 |
| other | Alveolar osteitis | Infections and infestations | Naproxen Sodium 220 mg | 1 | 147 | 1 |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Naproxen Sodium/ Caffeine 220/65 mg | 0 | 147 |
| Total, all-cause mortality | Naproxen Sodium/Caffeine 2x220/65 mg | 0 | 148 |
| Total, all-cause mortality | Placebo | 0 | 49 |
| Total, all-cause mortality | Caffeine 100 mg | 0 | 50 |
| Total, all-cause mortality | Naproxen Sodium 220 mg | 0 | 147 |
| Total, other adverse events | Naproxen Sodium/ Caffeine 220/65 mg | 19 | 147 |
| Total, other adverse events | Naproxen Sodium/Caffeine 2x220/65 mg | 11 | 148 |
| Total, other adverse events | Placebo | 4 | 49 |
| Total, other adverse events | Caffeine 100 mg | 3 | 50 |
| Total, other adverse events | Naproxen Sodium 220 mg | 23 | 147 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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