Trial Outcomes & Findings for Study to Find Out the Optimal Dose of Caffeine in the Combination Tablet of Naproxen Sodium and Caffeine in Patients Experiencing Moderate to Severe Pain After Having Wisdom Teeth Removed (NCT NCT04132336)
NCT ID: NCT04132336
Last Updated: 2021-09-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
193 participants
Primary outcome timeframe
Up to 8 hours post dose
Results posted on
2021-09-01
Participant Flow
Study was conducted at a single center in United States with first participant first visit on 12-Nov-2019 and last participant last visit on 02-Mar-2020. Study was completed on 03-Mar-2020 (End of follow up, phone call).
A total of 193 participants, including 32 in each of the naproxen sodium containing groups, 16 in the caffeine group, and 17 in the placebo group, underwent dental surgery and were randomized to study drug
Participant milestones
| Measure |
Naproxen Sodium/Caffeine-Dose 1
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 2
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 3
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
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
|
Naproxen Sodium
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
|
Caffeine
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
|
Placebo
Participants received a single dose of two tablets of matching placebo after extraction of third molars
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
32
|
32
|
32
|
16
|
17
|
|
Overall Study
COMPLETED
|
32
|
31
|
32
|
32
|
32
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Naproxen Sodium/Caffeine-Dose 1
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 2
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 3
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
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
|
Naproxen Sodium
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
|
Caffeine
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
|
Placebo
Participants received a single dose of two tablets of matching placebo after extraction of third molars
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Investigator Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study to Find Out the Optimal Dose of Caffeine in the Combination Tablet of Naproxen Sodium and Caffeine in Patients Experiencing Moderate to Severe Pain After Having Wisdom Teeth Removed
Baseline characteristics by cohort
| Measure |
Naproxen Sodium/Caffeine-Dose 1
n=32 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 2
n=32 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 3
n=32 Participants
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
n=32 Participants
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
|
Naproxen Sodium
n=32 Participants
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
|
Caffeine
n=16 Participants
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
|
Placebo
n=17 Participants
Participants received a single dose of two tablets of matching placebo after extraction of third molars
|
Total
n=193 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
17.0 years
STANDARD_DEVIATION 1.03 • n=5 Participants
|
17.4 years
STANDARD_DEVIATION 2.42 • n=7 Participants
|
17.1 years
STANDARD_DEVIATION 1.34 • n=5 Participants
|
17.3 years
STANDARD_DEVIATION 1.49 • n=4 Participants
|
17.9 years
STANDARD_DEVIATION 2.74 • n=21 Participants
|
17.3 years
STANDARD_DEVIATION 1.70 • n=10 Participants
|
17.7 years
STANDARD_DEVIATION 1.40 • n=115 Participants
|
17.4 years
STANDARD_DEVIATION 1.86 • n=6 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
77 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
116 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
10 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
183 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Baseline Pain Intensity Score
No Pain (0)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Baseline Pain Intensity Score
Mild Pain (1)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Baseline Pain Intensity Score
Moderate Pain (2)
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
70 Participants
n=6 Participants
|
|
Baseline Pain Intensity Score
Severe Pain (3)
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
123 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Up to 8 hours post dosePain 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.
Outcome measures
| Measure |
Naproxen Sodium/Caffeine-Dose 1
n=32 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 2
n=31 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 3
n=32 Participants
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
n=32 Participants
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
|
Naproxen Sodium
n=32 Participants
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
|
Caffeine
n=16 Participants
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
|
Placebo
n=16 Participants
Participants received a single dose of two tablets of matching placebo after extraction of third molars
|
|---|---|---|---|---|---|---|---|
|
Sum of Pain Intensity Difference (SPID) Over 8 Hours
|
35.45 Scores on a scale*hours
Standard Deviation 14.517 • Interval 14.517 to
|
37.87 Scores on a scale*hours
Standard Deviation 16.876 • Interval 16.876 to
|
30.70 Scores on a scale*hours
Standard Deviation 17.679 • Interval 17.679 to
|
36.02 Scores on a scale*hours
Standard Deviation 14.825 • Interval 14.825 to
|
29.95 Scores on a scale*hours
Standard Deviation 19.067 • Interval 19.067 to
|
8.75 Scores on a scale*hours
Standard Deviation 21.465 • Interval 21.465 to
|
6.03 Scores on a scale*hours
Standard Deviation 17.810 • Interval 17.81 to
|
SECONDARY outcome
Timeframe: Up to 2 hours, 4 hours and 12 hours post dosePain 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 0-2 ranges from -20 to 20, SPID 0-4 ranges from -40 to 40 and SPID 0-12 ranges from -120 to 120. A higher value indicates a better pain reduction.
Outcome measures
| Measure |
Naproxen Sodium/Caffeine-Dose 1
n=32 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 2
n=31 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 3
n=32 Participants
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
n=32 Participants
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
|
Naproxen Sodium
n=32 Participants
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
|
Caffeine
n=16 Participants
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
|
Placebo
n=16 Participants
Participants received a single dose of two tablets of matching placebo after extraction of third molars
|
|---|---|---|---|---|---|---|---|
|
Sum of Pain Intensity Differences (SPIDs) From 0 to 2, 4 and 12 Hours Post-dose
SPID 0-2
|
8.30 Scores on a scale*hours
Standard Deviation 3.141 • Interval 3.141 to
|
8.68 Scores on a scale*hours
Standard Deviation 3.789 • Interval 3.789 to
|
7.17 Scores on a scale*hours
Standard Deviation 3.721 • Interval 3.721 to
|
6.92 Scores on a scale*hours
Standard Deviation 3.501 • Interval 3.501 to
|
6.05 Scores on a scale*hours
Standard Deviation 3.511 • Interval 3.511 to
|
2.13 Scores on a scale*hours
Standard Deviation 4.060 • Interval 4.06 to
|
1.16 Scores on a scale*hours
Standard Deviation 2.925 • Interval 2.925 to
|
|
Sum of Pain Intensity Differences (SPIDs) From 0 to 2, 4 and 12 Hours Post-dose
SPID 0-12
|
50.58 Scores on a scale*hours
Standard Deviation 24.237 • Interval 24.237 to
|
52.45 Scores on a scale*hours
Standard Deviation 27.305 • Interval 27.305 to
|
44.80 Scores on a scale*hours
Standard Deviation 28.929 • Interval 28.929 to
|
52.45 Scores on a scale*hours
Standard Deviation 23.022 • Interval 23.022 to
|
43.08 Scores on a scale*hours
Standard Deviation 30.034 • Interval 30.034 to
|
12.44 Scores on a scale*hours
Standard Deviation 32.059 • Interval 32.059 to
|
1.15 Scores on a scale*hours
Standard Deviation 2.833 • Interval 2.833 to
|
|
Sum of Pain Intensity Differences (SPIDs) From 0 to 2, 4 and 12 Hours Post-dose
SPID 0-4
|
18.02 Scores on a scale*hours
Standard Deviation 6.387 • Interval 6.387 to
|
19.26 Scores on a scale*hours
Standard Deviation 8.019 • Interval 8.019 to
|
15.58 Scores on a scale*hours
Standard Deviation 7.697 • Interval 7.697 to
|
17.05 Scores on a scale*hours
Standard Deviation 7.232 • Interval 7.232 to
|
14.33 Scores on a scale*hours
Standard Deviation 8.391 • Interval 8.391 to
|
4.50 Scores on a scale*hours
Standard Deviation 9.604 • Interval 9.604 to
|
2.59 Scores on a scale*hours
Standard Deviation 7.625 • Interval 7.625 to
|
SECONDARY outcome
Timeframe: Up to 8 hours post dosePain relief is measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total Pain Relief is calculated as the area under the curve of pain relief score over time for the given time period by multiplying the pain relief score at each time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. TOTPAR over 8 hours ranges from 0 to 32, a higher value indicates more pain relief.
Outcome measures
| Measure |
Naproxen Sodium/Caffeine-Dose 1
n=32 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 2
n=31 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 3
n=32 Participants
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
n=32 Participants
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
|
Naproxen Sodium
n=32 Participants
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
|
Caffeine
n=16 Participants
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
|
Placebo
n=16 Participants
Participants received a single dose of two tablets of matching placebo after extraction of third molars
|
|---|---|---|---|---|---|---|---|
|
Total Pain Relief (TOTPAR) Over 8 Hours
|
19.58 Scores on a scale*hours
Standard Deviation 7.007 • Interval 7.007 to
|
20.26 Scores on a scale*hours
Standard Deviation 7.673 • Interval 7.673 to
|
17.41 Scores on a scale*hours
Standard Deviation 8.063 • Interval 8.063 to
|
19.53 Scores on a scale*hours
Standard Deviation 6.448 • Interval 6.448 to
|
16.27 Scores on a scale*hours
Standard Deviation 8.514 • Interval 8.514 to
|
7.03 Scores on a scale*hours
Standard Deviation 9.283 • Interval 9.283 to
|
5.44 Scores on a scale*hours
Standard Deviation 7.709 • Interval 7.709 to
|
SECONDARY outcome
Timeframe: Up to 2 hours, 4 hours and 12 hours post dosePain relief is measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total Pain Relief is calculated as the area under the curve of pain relief score over time for the given time period by multiplying the pain relief score at each time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. TOTPAR 0-2 ranges from 0 to 8, TOTPAR 0-4 ranges from 0 to 16, and TOTPAR 0-12 ranges from 0 to 48. A higher value indicates more pain relief
Outcome measures
| Measure |
Naproxen Sodium/Caffeine-Dose 1
n=32 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 2
n=31 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 3
n=32 Participants
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
n=32 Participants
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
|
Naproxen Sodium
n=32 Participants
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
|
Caffeine
n=16 Participants
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
|
Placebo
n=16 Participants
Participants received a single dose of two tablets of matching placebo after extraction of third molars
|
|---|---|---|---|---|---|---|---|
|
Total Pain Relief (TOTPAR) From 0 to 2, 4 and 12 Hours Post-dose
TOTPAR 0-12
|
28.20 Scores on a scale*hours
Standard Deviation 12.262 • Interval 12.262 to
|
28.26 Scores on a scale*hours
Standard Deviation 12.690 • Interval 12.69 to
|
25.13 Scores on a scale*hours
Standard Deviation 13.291 • Interval 13.291 to
|
28.72 Scores on a scale*hours
Standard Deviation 10.678 • Interval 10.678 to
|
22.95 Scores on a scale*hours
Standard Deviation 13.206 • Interval 13.206 to
|
10.28 Scores on a scale*hours
Standard Deviation 13.882 • Interval 13.882 to
|
8.44 Scores on a scale*hours
Standard Deviation 12.419 • Interval 12.419 to
|
|
Total Pain Relief (TOTPAR) From 0 to 2, 4 and 12 Hours Post-dose
TOTPAR 0-2
|
4.83 Scores on a scale*hours
Standard Deviation 1.401 • Interval 1.401 to
|
4.77 Scores on a scale*hours
Standard Deviation 1.731 • Interval 1.731 to
|
4.22 Scores on a scale*hours
Standard Deviation 1.596 • Interval 1.596 to
|
3.97 Scores on a scale*hours
Standard Deviation 1.436 • Interval 1.436 to
|
3.52 Scores on a scale*hours
Standard Deviation 1.644 • Interval 1.644 to
|
1.66 Scores on a scale*hours
Standard Deviation 1.767 • Interval 1.767 to
|
1.06 Scores on a scale*hours
Standard Deviation 1.328 • Interval 1.328 to
|
|
Total Pain Relief (TOTPAR) From 0 to 2, 4 and 12 Hours Post-dose
TOTPAR 0-4
|
10.27 Scores on a scale*hours
Standard Deviation 2.750 • Interval 2.75 to
|
10.29 Scores on a scale*hours
Standard Deviation 3.449 • Interval 3.449 to
|
8.84 Scores on a scale*hours
Standard Deviation 3.286 • Interval 3.286 to
|
9.28 Scores on a scale*hours
Standard Deviation 2.842 • Interval 2.842 to
|
7.86 Scores on a scale*hours
Standard Deviation 3.813 • Interval 3.813 to
|
3.59 Scores on a scale*hours
Standard Deviation 4.148 • Interval 4.148 to
|
2.44 Scores on a scale*hours
Standard Deviation 3.281 • Interval 3.281 to
|
SECONDARY outcome
Timeframe: Up to 12 hours post doseOutcome measures
| Measure |
Naproxen Sodium/Caffeine-Dose 1
n=32 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 2
n=31 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 3
n=32 Participants
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
n=32 Participants
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
|
Naproxen Sodium
n=32 Participants
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
|
Caffeine
n=16 Participants
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
|
Placebo
n=16 Participants
Participants received a single dose of two tablets of matching placebo after extraction of third molars
|
|---|---|---|---|---|---|---|---|
|
Time to First Use of Rescue Medication
|
NA hours
NA= insufficient number of participants with events
|
NA hours
Interval 8.967 to
NA= insufficient number of participants with events
|
NA hours
Interval 8.817 to
NA= insufficient number of participants with events
|
NA hours
NA= insufficient number of participants with events
|
NA hours
Interval 8.125 to
NA= insufficient number of participants with events
|
2.083 hours
Interval 1.275 to
NA= insufficient number of participants with events
|
2.125 hours
Interval 1.408 to
NA= insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to 12 hours post doseOutcome measures
| Measure |
Naproxen Sodium/Caffeine-Dose 1
n=32 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 2
n=31 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 3
n=32 Participants
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
n=32 Participants
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
|
Naproxen Sodium
n=32 Participants
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
|
Caffeine
n=16 Participants
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
|
Placebo
n=16 Participants
Participants received a single dose of two tablets of matching placebo after extraction of third molars
|
|---|---|---|---|---|---|---|---|
|
The Cumulative Percentage of Participants Taking Rescue Medication
9 Hours Post-Dose
|
21.9 Percentage of participants
|
25.8 Percentage of participants
|
25.0 Percentage of participants
|
9.4 Percentage of participants
|
28.1 Percentage of participants
|
68.8 Percentage of participants
|
75.0 Percentage of participants
|
|
The Cumulative Percentage of Participants Taking Rescue Medication
2 Hours Post-Dose
|
0 Percentage of participants
|
3.2 Percentage of participants
|
3.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
50 Percentage of participants
|
37.5 Percentage of participants
|
|
The Cumulative Percentage of Participants Taking Rescue Medication
3 Hours Post-Dose
|
0 Percentage of participants
|
6.5 Percentage of participants
|
6.3 Percentage of participants
|
3.1 Percentage of participants
|
15.6 Percentage of participants
|
56.3 Percentage of participants
|
56.3 Percentage of participants
|
|
The Cumulative Percentage of Participants Taking Rescue Medication
4 Hours Post-Dose
|
3.1 Percentage of participants
|
6.5 Percentage of participants
|
9.4 Percentage of participants
|
3.1 Percentage of participants
|
18.8 Percentage of participants
|
56.3 Percentage of participants
|
68.8 Percentage of participants
|
|
The Cumulative Percentage of Participants Taking Rescue Medication
5 Hours Post-Dose
|
9.4 Percentage of participants
|
6.5 Percentage of participants
|
15.6 Percentage of participants
|
3.1 Percentage of participants
|
18.8 Percentage of participants
|
62.5 Percentage of participants
|
68.8 Percentage of participants
|
|
The Cumulative Percentage of Participants Taking Rescue Medication
6 Hours Post-Dose
|
9.4 Percentage of participants
|
9.7 Percentage of participants
|
18.8 Percentage of participants
|
6.3 Percentage of participants
|
21.9 Percentage of participants
|
68.8 Percentage of participants
|
68.8 Percentage of participants
|
|
The Cumulative Percentage of Participants Taking Rescue Medication
7 Hours Post-Dose
|
12.5 Percentage of participants
|
9.7 Percentage of participants
|
21.9 Percentage of participants
|
6.3 Percentage of participants
|
21.9 Percentage of participants
|
68.8 Percentage of participants
|
68.8 Percentage of participants
|
|
The Cumulative Percentage of Participants Taking Rescue Medication
8 Hours Post-Dose
|
15.6 Percentage of participants
|
9.7 Percentage of participants
|
21.9 Percentage of participants
|
9.4 Percentage of participants
|
21.9 Percentage of participants
|
68.8 Percentage of participants
|
75.0 Percentage of participants
|
|
The Cumulative Percentage of Participants Taking Rescue Medication
0.5 Hours Post-Dose
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
The Cumulative Percentage of Participants Taking Rescue Medication
1 Hour Post-Dose
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
The Cumulative Percentage of Participants Taking Rescue Medication
12 Hours Post-Dose
|
25.0 Percentage of participants
|
29.0 Percentage of participants
|
28.1 Percentage of participants
|
18.8 Percentage of participants
|
34.4 Percentage of participants
|
75.0 Percentage of participants
|
75.0 Percentage of participants
|
|
The Cumulative Percentage of Participants Taking Rescue Medication
1.5 Hours Post-Dose
|
0 Percentage of participants
|
3.2 Percentage of participants
|
3.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
37.5 Percentage of participants
|
25.0 Percentage of participants
|
|
The Cumulative Percentage of Participants Taking Rescue Medication
10 Hours Post-Dose
|
25.0 Percentage of participants
|
25.8 Percentage of participants
|
28.1 Percentage of participants
|
15.6 Percentage of participants
|
31.3 Percentage of participants
|
68.8 Percentage of participants
|
75.0 Percentage of participants
|
|
The Cumulative Percentage of Participants Taking Rescue Medication
11 Hours Post-Dose
|
25.0 Percentage of participants
|
25.8 Percentage of participants
|
28.1 Percentage of participants
|
15.6 Percentage of participants
|
34.4 Percentage of participants
|
68.8 Percentage of participants
|
75.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 hours post dosePain 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
Outcome measures
| Measure |
Naproxen Sodium/Caffeine-Dose 1
n=32 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 2
n=31 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 3
n=32 Participants
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
n=31 Participants
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
|
Naproxen Sodium
n=32 Participants
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
|
Caffeine
n=16 Participants
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
|
Placebo
n=16 Participants
Participants received a single dose of two tablets of matching placebo after extraction of third molars
|
|---|---|---|---|---|---|---|---|
|
Pain Intensity Difference (PID) at Each Evaluation
0.5 Hours Post-Dose
|
2.3 Scores on a scale
Standard Deviation 2.07
|
2.6 Scores on a scale
Standard Deviation 1.82
|
2.1 Scores on a scale
Standard Deviation 2.23
|
1.4 Scores on a scale
Standard Deviation 1.56
|
1.5 Scores on a scale
Standard Deviation 1.34
|
0.8 Scores on a scale
Standard Deviation 0.98
|
0.5 Scores on a scale
Standard Deviation 0.89
|
|
Pain Intensity Difference (PID) at Each Evaluation
1.5 Hours Post-Dose
|
4.9 Scores on a scale
Standard Deviation 1.67
|
5.1 Scores on a scale
Standard Deviation 2.26
|
4.3 Scores on a scale
Standard Deviation 1.98
|
4.2 Scores on a scale
Standard Deviation 2.32
|
3.7 Scores on a scale
Standard Deviation 2.16
|
1.2 Scores on a scale
Standard Deviation 2.79
|
0.7 Scores on a scale
Standard Deviation 1.74
|
|
Pain Intensity Difference (PID) at Each Evaluation
6 Hours Post-Dose
|
4.6 Scores on a scale
Standard Deviation 2.24
|
4.8 Scores on a scale
Standard Deviation 2.42
|
3.8 Scores on a scale
Standard Deviation 2.87
|
4.9 Scores on a scale
Standard Deviation 2.40
|
3.9 Scores on a scale
Standard Deviation 2.88
|
1.1 Scores on a scale
Standard Deviation 3.19
|
1.0 Scores on a scale
Standard Deviation 3.06
|
|
Pain Intensity Difference (PID) at Each Evaluation
8 Hours Post-Dose
|
4.0 Scores on a scale
Standard Deviation 2.53
|
4.2 Scores on a scale
Standard Deviation 2.65
|
3.7 Scores on a scale
Standard Deviation 3.12
|
4.3 Scores on a scale
Standard Deviation 2.29
|
3.7 Scores on a scale
Standard Deviation 2.96
|
0.9 Scores on a scale
Standard Deviation 2.95
|
0.7 Scores on a scale
Standard Deviation 2.65
|
|
Pain Intensity Difference (PID) at Each Evaluation
11 Hours Post-Dose
|
3.8 Scores on a scale
Standard Deviation 2.92
|
3.5 Scores on a scale
Standard Deviation 3.02
|
3.6 Scores on a scale
Standard Deviation 3.17
|
4.2 Scores on a scale
Standard Deviation 2.79
|
3.1 Scores on a scale
Standard Deviation 3.02
|
0.8 Scores on a scale
Standard Deviation 2.99
|
0.9 Scores on a scale
Standard Deviation 2.96
|
|
Pain Intensity Difference (PID) at Each Evaluation
1 Hour Post-Dose
|
4.2 Scores on a scale
Standard Deviation 1.88
|
4.2 Scores on a scale
Standard Deviation 2.44
|
3.7 Scores on a scale
Standard Deviation 1.95
|
3.4 Scores on a scale
Standard Deviation 2.39
|
2.9 Scores on a scale
Standard Deviation 1.88
|
1.2 Scores on a scale
Standard Deviation 2.26
|
0.6 Scores on a scale
Standard Deviation 1.71
|
|
Pain Intensity Difference (PID) at Each Evaluation
2 Hours Post-Dose
|
5.1 Scores on a scale
Standard Deviation 1.76
|
5.5 Scores on a scale
Standard Deviation 2.20
|
4.3 Scores on a scale
Standard Deviation 2.23
|
4.8 Scores on a scale
Standard Deviation 2.23
|
4.1 Scores on a scale
Standard Deviation 2.22
|
1.1 Scores on a scale
Standard Deviation 2.67
|
0.5 Scores on a scale
Standard Deviation 1
|
|
Pain Intensity Difference (PID) at Each Evaluation
3 Hours Post-Dose
|
5.0 Scores on a scale
Standard Deviation 1.82
|
5.4 Scores on a scale
Standard Deviation 2.27
|
4.3 Scores on a scale
Standard Deviation 2.33
|
5.0 Scores on a scale
Standard Deviation 2.29
|
4.0 Scores on a scale
Standard Deviation 2.83
|
1.1 Scores on a scale
Standard Deviation 2.85
|
0.6 Scores on a scale
Standard Deviation 2.42
|
|
Pain Intensity Difference (PID) at Each Evaluation
4 Hours Post-Dose
|
4.8 Scores on a scale
Standard Deviation 2.17
|
5.2 Scores on a scale
Standard Deviation 2.59
|
4.1 Scores on a scale
Standard Deviation 2.62
|
5.1 Scores on a scale
Standard Deviation 2.27
|
4.3 Scores on a scale
Standard Deviation 2.82
|
1.3 Scores on a scale
Standard Deviation 3.11
|
0.9 Scores on a scale
Standard Deviation 2.78
|
|
Pain Intensity Difference (PID) at Each Evaluation
5 Hours Post-Dose
|
4.7 Scores on a scale
Standard Deviation 2.28
|
5.0 Scores on a scale
Standard Deviation 2.42
|
4.0 Scores on a scale
Standard Deviation 2.72
|
5.0 Scores on a scale
Standard Deviation 2.25
|
4.1 Scores on a scale
Standard Deviation 2.83
|
1.1 Scores on a scale
Standard Deviation 3.14
|
1.0 Scores on a scale
Standard Deviation 2.92
|
|
Pain Intensity Difference (PID) at Each Evaluation
7 Hours Post-Dose
|
4.3 Scores on a scale
Standard Deviation 2.55
|
4.5 Scores on a scale
Standard Deviation 2.45
|
3.8 Scores on a scale
Standard Deviation 3.07
|
4.7 Scores on a scale
Standard Deviation 2.31
|
3.9 Scores on a scale
Standard Deviation 3.08
|
1.1 Scores on a scale
Standard Deviation 3.36
|
0.8 Scores on a scale
Standard Deviation 2.49
|
|
Pain Intensity Difference (PID) at Each Evaluation
9 Hours Post-Dose
|
3.8 Scores on a scale
Standard Deviation 2.71
|
3.8 Scores on a scale
Standard Deviation 3.12
|
3.6 Scores on a scale
Standard Deviation 3.00
|
4.2 Scores on a scale
Standard Deviation 2.45
|
3.6 Scores on a scale
Standard Deviation 3.14
|
1.1 Scores on a scale
Standard Deviation 3.09
|
0.8 Scores on a scale
Standard Deviation 2.74
|
|
Pain Intensity Difference (PID) at Each Evaluation
10 Hours Post-Dose
|
3.8 Scores on a scale
Standard Deviation 2.88
|
3.7 Scores on a scale
Standard Deviation 3.04
|
3.4 Scores on a scale
Standard Deviation 3.15
|
4.1 Scores on a scale
Standard Deviation 2.60
|
3.3 Scores on a scale
Standard Deviation 3.07
|
1.1 Scores on a scale
Standard Deviation 3.07
|
0.9 Scores on a scale
Standard Deviation 2.99
|
|
Pain Intensity Difference (PID) at Each Evaluation
12 Hours Post-Dose
|
3.8 Scores on a scale
Standard Deviation 2.97
|
3.6 Scores on a scale
Standard Deviation 3.06
|
3.5 Scores on a scale
Standard Deviation 3.38
|
4.0 Scores on a scale
Standard Deviation 2.92
|
3.1 Scores on a scale
Standard Deviation 2.97
|
0.8 Scores on a scale
Standard Deviation 3.00
|
0.9 Scores on a scale
Standard Deviation 2.96
|
SECONDARY outcome
Timeframe: Up to 12 hours post dosePain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). Participants circle a number (from 0 to 10) on the Numerical Rating Scale to indicate the severity the pain they are experiencing at baseline and at each post dose time point. 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).
Outcome measures
| Measure |
Naproxen Sodium/Caffeine-Dose 1
n=32 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 2
n=31 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 3
n=32 Participants
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
n=32 Participants
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
|
Naproxen Sodium
n=32 Participants
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
|
Caffeine
n=16 Participants
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
|
Placebo
n=16 Participants
Participants received a single dose of two tablets of matching placebo after extraction of third molars
|
|---|---|---|---|---|---|---|---|
|
Peak Pain Intensity Difference (PID)
|
6.0 Scores on a scale
Standard Deviation 1.53 • Interval 1.53 to
|
6.2 Scores on a scale
Standard Deviation 1.97 • Interval 1.97 to
|
5.9 Scores on a scale
Standard Deviation 2.01 • Interval 2.01 to
|
6.3 Scores on a scale
Standard Deviation 1.72 • Interval 1.72 to
|
5.3 Scores on a scale
Standard Deviation 2.57 • Interval 2.57 to
|
2.7 Scores on a scale
Standard Deviation 2.94 • Interval 2.94 to
|
2.3 Scores on a scale
Standard Deviation 2.98 • Interval 2.98 to
|
SECONDARY outcome
Timeframe: Up to 12 hours post dosePain relief is measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief)
Outcome measures
| Measure |
Naproxen Sodium/Caffeine-Dose 1
n=32 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 2
n=31 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 3
n=32 Participants
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
n=32 Participants
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
|
Naproxen Sodium
n=32 Participants
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
|
Caffeine
n=16 Participants
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
|
Placebo
n=16 Participants
Participants received a single dose of two tablets of matching placebo after extraction of third molars
|
|---|---|---|---|---|---|---|---|
|
Pain Relief Score at Each Evaluation
3 Hours Post-Dose
|
2.8 Scores on a scale
Standard Deviation 0.79 • Interval 0.79 to
|
2.8 Scores on a scale
Standard Deviation 0.97 • Interval 0.97 to
|
2.4 Scores on a scale
Standard Deviation 1.04 • Interval 1.04 to
|
2.6 Scores on a scale
Standard Deviation 0.91 • Interval 0.91 to
|
2.1 Scores on a scale
Standard Deviation 1.21 • Interval 1.21 to
|
0.9 Scores on a scale
Standard Deviation 1.24 • Interval 1.24 to
|
0.6 Scores on a scale
Standard Deviation 1.09 • Interval 1.09 to
|
|
Pain Relief Score at Each Evaluation
4 Hours Post-Dose
|
2.7 Scores on a scale
Standard Deviation 1.07 • Interval 1.07 to
|
2.7 Scores on a scale
Standard Deviation 1.19 • Interval 1.19 to
|
2.3 Scores on a scale
Standard Deviation 1.16 • Interval 1.16 to
|
2.7 Scores on a scale
Standard Deviation 0.96 • Interval 0.96 to
|
2.2 Scores on a scale
Standard Deviation 1.26 • Interval 1.26 to
|
1.0 Scores on a scale
Standard Deviation 1.37 • Interval 1.37 to
|
0.8 Scores on a scale
Standard Deviation 1.18 • Interval 1.18 to
|
|
Pain Relief Score at Each Evaluation
8 Hours Post-Dose
|
2.1 Scores on a scale
Standard Deviation 1.33 • Interval 1.33 to
|
2.3 Scores on a scale
Standard Deviation 1.28 • Interval 1.28 to
|
2.1 Scores on a scale
Standard Deviation 1.46 • Interval 1.46 to
|
2.4 Scores on a scale
Standard Deviation 1.19 • Interval 1.19 to
|
2.0 Scores on a scale
Standard Deviation 1.28 • Interval 1.28 to
|
0.8 Scores on a scale
Standard Deviation 1.33 • Interval 1.33 to
|
0.7 Scores on a scale
Standard Deviation 1.25 • Interval 1.25 to
|
|
Pain Relief Score at Each Evaluation
11 Hours Post-Dose
|
2.1 Scores on a scale
Standard Deviation 1.52 • Interval 1.52 to
|
1.9 Scores on a scale
Standard Deviation 1.40 • Interval 1.4 to
|
1.9 Scores on a scale
Standard Deviation 1.48 • Interval 1.48 to
|
2.4 Scores on a scale
Standard Deviation 1.34 • Interval 1.34 to
|
1.4 Scores on a scale
Standard Deviation 1.32 • Interval 1.32 to
|
0.8 Scores on a scale
Standard Deviation 1.34 • Interval 1.34 to
|
0.8 Scores on a scale
Standard Deviation 1.34 • Interval 1.34 to
|
|
Pain Relief Score at Each Evaluation
0.5 Hours Post-Dose
|
1.6 Scores on a scale
Standard Deviation 1.08 • Interval 1.08 to
|
1.5 Scores on a scale
Standard Deviation 0.89 • Interval 0.89 to
|
1.5 Scores on a scale
Standard Deviation 1.02 • Interval 1.02 to
|
0.9 Scores on a scale
Standard Deviation 0.80 • Interval 0.8 to
|
1.0 Scores on a scale
Standard Deviation 0.74 • Interval 0.74 to
|
0.6 Scores on a scale
Standard Deviation 0.62 • Interval 0.62 to
|
0.4 Scores on a scale
Standard Deviation 0.63 • Interval 0.63 to
|
|
Pain Relief Score at Each Evaluation
1 Hours Post-Dose
|
2.4 Scores on a scale
Standard Deviation 0.84 • Interval 0.84 to
|
2.3 Scores on a scale
Standard Deviation 1.22 • Interval 1.22 to
|
2.2 Scores on a scale
Standard Deviation 0.91 • Interval 0.91 to
|
2.0 Scores on a scale
Standard Deviation 1.14 • Interval 1.14 to
|
1.8 Scores on a scale
Standard Deviation 0.91 • Interval 0.91 to
|
0.9 Scores on a scale
Standard Deviation 1.00 • Interval 1.0 to
|
0.6 Scores on a scale
Standard Deviation 0.81 • Interval 0.81 to
|
|
Pain Relief Score at Each Evaluation
1.5 Hours Post-Dose
|
2.8 Scores on a scale
Standard Deviation 0.64 • Interval 0.64 to
|
2.8 Scores on a scale
Standard Deviation 0.99 • Interval 0.99 to
|
2.3 Scores on a scale
Standard Deviation 0.87 • Interval 0.87 to
|
2.4 Scores on a scale
Standard Deviation 0.91 • Interval 0.91 to
|
2.0 Scores on a scale
Standard Deviation 1.05 • Interval 1.05 to
|
0.9 Scores on a scale
Standard Deviation 1.24 • Interval 1.24 to
|
0.6 Scores on a scale
Standard Deviation 0.73 • Interval 0.73 to
|
|
Pain Relief Score at Each Evaluation
2 Hours Post-Dose
|
2.8 Scores on a scale
Standard Deviation 0.85 • Interval 0.85 to
|
2.9 Scores on a scale
Standard Deviation 1.01 • Interval 1.01 to
|
2.4 Scores on a scale
Standard Deviation 1.01 • Interval 1.01 to
|
2.6 Scores on a scale
Standard Deviation 0.79 • Interval 0.79 to
|
2.2 Scores on a scale
Standard Deviation 1.01 • Interval 1.01 to
|
0.8 Scores on a scale
Standard Deviation 1.05 • Interval 1.05 to
|
0.5 Scores on a scale
Standard Deviation 0.82 • Interval 0.82 to
|
|
Pain Relief Score at Each Evaluation
5 Hours Post-Dose
|
2.6 Scores on a scale
Standard Deviation 1.16 • Interval 1.16 to
|
2.6 Scores on a scale
Standard Deviation 1.15 • Interval 1.15 to
|
2.3 Scores on a scale
Standard Deviation 1.27 • Interval 1.27 to
|
2.7 Scores on a scale
Standard Deviation 1.00 • Interval 1.0 to
|
2.2 Scores on a scale
Standard Deviation 1.24 • Interval 1.24 to
|
0.9 Scores on a scale
Standard Deviation 1.36 • Interval 1.36 to
|
0.8 Scores on a scale
Standard Deviation 1.18 • Interval 1.18 to
|
|
Pain Relief Score at Each Evaluation
6 Hours Post-Dose
|
2.4 Scores on a scale
Standard Deviation 1.16 • Interval 1.16 to
|
2.6 Scores on a scale
Standard Deviation 1.18 • Interval 1.18 to
|
2.2 Scores on a scale
Standard Deviation 1.35 • Interval 1.35 to
|
2.7 Scores on a scale
Standard Deviation 1.10 • Interval 1.1 to
|
2.1 Scores on a scale
Standard Deviation 1.30 • Interval 1.3 to
|
0.9 Scores on a scale
Standard Deviation 1.45 • Interval 1.45 to
|
0.8 Scores on a scale
Standard Deviation 1.24 • Interval 1.24 to
|
|
Pain Relief Score at Each Evaluation
7 Hours Post-Dose
|
2.3 Scores on a scale
Standard Deviation 1.34 • Interval 1.34 to
|
2.5 Scores on a scale
Standard Deviation 1.15 • Interval 1.15 to
|
2.1 Scores on a scale
Standard Deviation 1.38 • Interval 1.38 to
|
2.5 Scores on a scale
Standard Deviation 1.08 • Interval 1.08 to
|
2.1 Scores on a scale
Standard Deviation 1.29 • Interval 1.29 to
|
0.9 Scores on a scale
Standard Deviation 1.50 • Interval 1.5 to
|
0.8 Scores on a scale
Standard Deviation 1.28 • Interval 1.28 to
|
|
Pain Relief Score at Each Evaluation
9 Hours Post-Dose
|
2.2 Scores on a scale
Standard Deviation 1.40 • Interval 1.4 to
|
2.1 Scores on a scale
Standard Deviation 1.48 • Interval 1.48 to
|
2.0 Scores on a scale
Standard Deviation 1.45 • Interval 1.45 to
|
2.3 Scores on a scale
Standard Deviation 1.12 • Interval 1.12 to
|
1.9 Scores on a scale
Standard Deviation 1.41 • Interval 1.41 to
|
0.9 Scores on a scale
Standard Deviation 1.36 • Interval 1.36 to
|
0.8 Scores on a scale
Standard Deviation 1.34 • Interval 1.34 to
|
|
Pain Relief Score at Each Evaluation
10 Hours Post-Dose
|
2.2 Scores on a scale
Standard Deviation 1.51 • Interval 1.51 to
|
2.0 Scores on a scale
Standard Deviation 1.43 • Interval 1.43 to
|
1.8 Scores on a scale
Standard Deviation 1.42 • Interval 1.42 to
|
2.3 Scores on a scale
Standard Deviation 1.28 • Interval 1.28 to
|
1.8 Scores on a scale
Standard Deviation 1.41 • Interval 1.41 to
|
0.9 Scores on a scale
Standard Deviation 1.36 • Interval 1.36 to
|
0.8 Scores on a scale
Standard Deviation 1.34 • Interval 1.34 to
|
|
Pain Relief Score at Each Evaluation
12 Hours Post-Dose
|
2.2 Scores on a scale
Standard Deviation 1.55 • Interval 1.55 to
|
1.9 Scores on a scale
Standard Deviation 1.46 • Interval 1.46 to
|
2.0 Scores on a scale
Standard Deviation 1.51 • Interval 1.51 to
|
2.2 Scores on a scale
Standard Deviation 1.45 • Interval 1.45 to
|
1.6 Scores on a scale
Standard Deviation 1.39 • Interval 1.39 to
|
0.8 Scores on a scale
Standard Deviation 1.34 • Interval 1.34 to
|
0.8 Scores on a scale
Standard Deviation 1.34 • Interval 1.34 to
|
SECONDARY outcome
Timeframe: Up to 12 hours post dosePain relief is measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). At each post-dose time point, participants check the appropriate box (from 0 to 4) on the Categorical Pain Relief Rating Scale to indicate the relief from starting pain at the post dose time points.
Outcome measures
| Measure |
Naproxen Sodium/Caffeine-Dose 1
n=32 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 2
n=31 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 3
n=32 Participants
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
n=32 Participants
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
|
Naproxen Sodium
n=32 Participants
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
|
Caffeine
n=16 Participants
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
|
Placebo
n=16 Participants
Participants received a single dose of two tablets of matching placebo after extraction of third molars
|
|---|---|---|---|---|---|---|---|
|
Peak Pain Relief Score
|
3.3 Scores on a scale
Standard Deviation 0.62 • Interval 0.62 to
|
3.2 Scores on a scale
Standard Deviation 0.78 • Interval 0.78 to
|
3.0 Scores on a scale
Standard Deviation 0.82 • Interval 0.82 to
|
3.1 Scores on a scale
Standard Deviation 0.66 • Interval 0.66 to
|
2.6 Scores on a scale
Standard Deviation 1.01 • Interval 1.01 to
|
1.6 Scores on a scale
Standard Deviation 1.55 • Interval 1.55 to
|
1.3 Scores on a scale
Standard Deviation 1.39 • Interval 1.39 to
|
SECONDARY outcome
Timeframe: Up to 12 hours post doseGlobal assessment is performed either at 12 hours post-dose or immediately prior to the first intake of rescue medication. Global assessment is based on the question 'Overall, I would rate the study medication I received: 0=Poor, 1=Fair, 2=Good, 3=Very Good, 4=Excellent.'
Outcome measures
| Measure |
Naproxen Sodium/Caffeine-Dose 1
n=32 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 2
n=31 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 3
n=32 Participants
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
n=32 Participants
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
|
Naproxen Sodium
n=32 Participants
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
|
Caffeine
n=16 Participants
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
|
Placebo
n=16 Participants
Participants received a single dose of two tablets of matching placebo after extraction of third molars
|
|---|---|---|---|---|---|---|---|
|
Global Assessment of the Investigational Product
Fair (1)
|
2 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
|
Global Assessment of the Investigational Product
Good (2)
|
5 Participants
|
6 Participants
|
9 Participants
|
7 Participants
|
6 Participants
|
4 Participants
|
1 Participants
|
|
Global Assessment of the Investigational Product
Very Good (3)
|
18 Participants
|
14 Participants
|
13 Participants
|
17 Participants
|
14 Participants
|
2 Participants
|
3 Participants
|
|
Global Assessment of the Investigational Product
Poor (0)
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
8 Participants
|
10 Participants
|
|
Global Assessment of the Investigational Product
Excellent (4)
|
6 Participants
|
9 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 5 days post doseOutcome measures
| Measure |
Naproxen Sodium/Caffeine-Dose 1
n=32 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 2
n=32 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 3
n=32 Participants
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
n=32 Participants
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
|
Naproxen Sodium
n=32 Participants
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
|
Caffeine
n=16 Participants
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
|
Placebo
n=17 Participants
Participants received a single dose of two tablets of matching placebo after extraction of third molars
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
6 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 5 days post doseOutcome measures
| Measure |
Naproxen Sodium/Caffeine-Dose 1
n=32 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 2
n=32 Participants
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 3
n=32 Participants
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
n=32 Participants
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
|
Naproxen Sodium
n=32 Participants
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
|
Caffeine
n=16 Participants
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
|
Placebo
n=17 Participants
Participants received a single dose of two tablets of matching placebo after extraction of third molars
|
|---|---|---|---|---|---|---|---|
|
The Number of Participants With Clinically Significant Changes in Physical Examinations and Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Naproxen Sodium/Caffeine-Dose 1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Naproxen Sodium/Caffeine-Dose 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Naproxen Sodium/Caffeine-Dose 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Naproxen Sodium/Caffeine-Dose 4
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Naproxen Sodium
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Caffeine
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Naproxen Sodium/Caffeine-Dose 1
n=32 participants at risk
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 2
n=32 participants at risk
Participants received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
|
Naproxen Sodium/Caffeine-Dose 3
n=32 participants at risk
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
n=32 participants at risk
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
|
Naproxen Sodium
n=32 participants at risk
Participants received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
|
Caffeine
n=16 participants at risk
Participants received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
|
Placebo
n=17 participants at risk
Participants received a single dose of two tablets of matching placebo after extraction of third molars
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
3.1%
1/32 • Number of events 1 • Up to 5 days post-dose
|
0.00%
0/16 • Up to 5 days post-dose
|
0.00%
0/17 • Up to 5 days post-dose
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
6.2%
1/16 • Number of events 1 • Up to 5 days post-dose
|
0.00%
0/17 • Up to 5 days post-dose
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • Number of events 1 • Up to 5 days post-dose
|
3.1%
1/32 • Number of events 1 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
6.2%
2/32 • Number of events 2 • Up to 5 days post-dose
|
6.2%
2/32 • Number of events 3 • Up to 5 days post-dose
|
25.0%
4/16 • Number of events 5 • Up to 5 days post-dose
|
0.00%
0/17 • Up to 5 days post-dose
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
2/32 • Number of events 2 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
6.2%
1/16 • Number of events 1 • Up to 5 days post-dose
|
11.8%
2/17 • Number of events 2 • Up to 5 days post-dose
|
|
General disorders
Chest discomfort
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/16 • Up to 5 days post-dose
|
5.9%
1/17 • Number of events 1 • Up to 5 days post-dose
|
|
General disorders
Feeling hot
|
0.00%
0/32 • Up to 5 days post-dose
|
3.1%
1/32 • Number of events 1 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
3.1%
1/32 • Number of events 1 • Up to 5 days post-dose
|
0.00%
0/16 • Up to 5 days post-dose
|
0.00%
0/17 • Up to 5 days post-dose
|
|
General disorders
Pyrexia
|
3.1%
1/32 • Number of events 1 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/16 • Up to 5 days post-dose
|
0.00%
0/17 • Up to 5 days post-dose
|
|
Infections and infestations
Alveolar osteitis
|
0.00%
0/32 • Up to 5 days post-dose
|
3.1%
1/32 • Number of events 1 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/16 • Up to 5 days post-dose
|
0.00%
0/17 • Up to 5 days post-dose
|
|
Infections and infestations
Cellulitis
|
3.1%
1/32 • Number of events 1 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/16 • Up to 5 days post-dose
|
0.00%
0/17 • Up to 5 days post-dose
|
|
Nervous system disorders
Dizziness
|
3.1%
1/32 • Number of events 1 • Up to 5 days post-dose
|
3.1%
1/32 • Number of events 1 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
3.1%
1/32 • Number of events 1 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/16 • Up to 5 days post-dose
|
5.9%
1/17 • Number of events 1 • Up to 5 days post-dose
|
|
Nervous system disorders
Headache
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
12.5%
2/16 • Number of events 2 • Up to 5 days post-dose
|
0.00%
0/17 • Up to 5 days post-dose
|
|
Nervous system disorders
Syncope
|
3.1%
1/32 • Number of events 1 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/16 • Up to 5 days post-dose
|
0.00%
0/17 • Up to 5 days post-dose
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
2/32 • Number of events 5 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
3.1%
1/32 • Number of events 1 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/16 • Up to 5 days post-dose
|
0.00%
0/17 • Up to 5 days post-dose
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/16 • Up to 5 days post-dose
|
5.9%
1/17 • Number of events 1 • Up to 5 days post-dose
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
6.2%
1/16 • Number of events 1 • Up to 5 days post-dose
|
0.00%
0/17 • Up to 5 days post-dose
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/32 • Up to 5 days post-dose
|
3.1%
1/32 • Number of events 1 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/32 • Up to 5 days post-dose
|
0.00%
0/16 • Up to 5 days post-dose
|
0.00%
0/17 • Up to 5 days post-dose
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place