Trial Outcomes & Findings for 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 NCT05485805)
NCT ID: NCT05485805
Last Updated: 2025-03-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
541 participants
Primary outcome timeframe
Up to 8 hours post-dose
Results posted on
2025-03-25
Participant Flow
The clinical study was conducted at a single study site in the United States between 21 September 2022 (first participant first visit) and 29 January 2024 (last participant last visit).
A total of 750 participants were screened at a single study center in the United States. 541 participants were randomly assigned to study intervention.
Participant milestones
| Measure |
Naproxen Sodium/ Caffeine 220/65 mg
Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.
|
Naproxen Sodium/Caffeine 2x220/65 mg
Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.
|
Naproxen Sodium 220 mg
Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.
|
Caffeine 100 mg
Participants received one tablet Caffeine 100 mg one tablet of placebo.
|
Placebo
Participants received two tablets of placebo.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
147
|
148
|
147
|
50
|
49
|
|
Overall Study
COMPLETED
|
145
|
144
|
142
|
49
|
47
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
5
|
1
|
2
|
Reasons for withdrawal
| Measure |
Naproxen Sodium/ Caffeine 220/65 mg
Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.
|
Naproxen Sodium/Caffeine 2x220/65 mg
Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.
|
Naproxen Sodium 220 mg
Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.
|
Caffeine 100 mg
Participants received one tablet Caffeine 100 mg one tablet of placebo.
|
Placebo
Participants received two tablets of placebo.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
2
|
0
|
2
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
3
|
1
|
0
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Naproxen Sodium/ Caffeine 220/65 mg
n=147 Participants
Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.
|
Naproxen Sodium/Caffeine 2x220/65 mg
n=148 Participants
Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.
|
Naproxen Sodium 220 mg
n=147 Participants
Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.
|
Caffeine 100 mg
n=50 Participants
Participants received one tablet Caffeine 100 mg one tablet of placebo.
|
Placebo
n=49 Participants
Participants received two tablets of placebo.
|
Total
n=541 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
18.3 years
STANDARD_DEVIATION 2.13 • n=99 Participants
|
18.1 years
STANDARD_DEVIATION 1.99 • n=107 Participants
|
18.1 years
STANDARD_DEVIATION 1.84 • n=206 Participants
|
17.7 years
STANDARD_DEVIATION 1.82 • n=7 Participants
|
17.9 years
STANDARD_DEVIATION 2.05 • n=31 Participants
|
18.1 years
STANDARD_DEVIATION 1.98 • n=30 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
243 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
26 Participants
n=31 Participants
|
298 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
11 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
140 Participants
n=99 Participants
|
139 Participants
n=107 Participants
|
135 Participants
n=206 Participants
|
45 Participants
n=7 Participants
|
46 Participants
n=31 Participants
|
505 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Up to 8 hours post-dosePain 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.
Outcome measures
| Measure |
Naproxen Sodium 220 mg
n=147 Participants
Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.
|
Caffeine 100 mg
n=50 Participants
Participants received one tablet Caffeine 100 mg one tablet of placebo.
|
Placebo
n=49 Participants
Participants received two tablets of placebo.
|
Naproxen Sodium/ Caffeine 220/65 mg
n=147 Participants
Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.
|
Naproxen Sodium/Caffeine 2x220/65 mg
n=148 Participants
Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.
|
|---|---|---|---|---|---|
|
Sum of Pain Intensity Difference (SPID) Over 8 Hours Post-dose
|
31.082 Points on scale
Standard Error 1.443 • Interval 1.443 to
|
5.146 Points on scale
Standard Error 2.470 • Interval 2.47 to
|
8.622 Points on scale
Standard Error 2.521 • Interval 2.521 to
|
31.293 Points on scale
Standard Error 1.441 • Interval 1.441 to
|
37.242 Points on scale
Standard Error 1.436 • Interval 1.436 to
|
SECONDARY outcome
Timeframe: from 0 to 2, 4, 6, 12 and 24 hours post-dosePain 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.
Outcome measures
| Measure |
Naproxen Sodium 220 mg
n=147 Participants
Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.
|
Caffeine 100 mg
n=50 Participants
Participants received one tablet Caffeine 100 mg one tablet of placebo.
|
Placebo
n=49 Participants
Participants received two tablets of placebo.
|
Naproxen Sodium/ Caffeine 220/65 mg
n=147 Participants
Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.
|
Naproxen Sodium/Caffeine 2x220/65 mg
n=148 Participants
Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.
|
|---|---|---|---|---|---|
|
Sum of Pain Intensity Differences From 0 to 2, 4, 6, 12 and 24 Hours Post-dose
0-2 hours post-dose
|
7.973 Points on scale
Standard Error 0.341 • Interval 0.341 to
|
1.876 Points on scale
Standard Error 0.585 • Interval 0.585 to
|
1.567 Points on scale
Standard Error 0.597 • Interval 0.597 to
|
7.347 Points on scale
Standard Error 0.341 • Interval 0.341 to
|
8.950 Points on scale
Standard Error 0.340 • Interval 0.34 to
|
|
Sum of Pain Intensity Differences From 0 to 2, 4, 6, 12 and 24 Hours Post-dose
0-4 hours post-dose
|
16.627 Points on scale
Standard Error 0.689 • Interval 0.689 to
|
2.924 Points on scale
Standard Error 1.179 • Interval 1.179 to
|
3.982 Points on scale
Standard Error 1.204 • Interval 1.204 to
|
15.899 Points on scale
Standard Error 0.688 • Interval 0.688 to
|
19.210 Points on scale
Standard Error 0.686 • Interval 0.686 to
|
|
Sum of Pain Intensity Differences From 0 to 2, 4, 6, 12 and 24 Hours Post-dose
0-6 hours post-dose
|
24.381 Points on scale
Standard Error 1.058 • Interval 1.058 to
|
4.024 Points on scale
Standard Error 1.812 • Interval 1.812 to
|
6.308 Points on scale
Standard Error 1.849 • Interval 1.849 to
|
23.851 Points on scale
Standard Error 1.057 • Interval 1.057 to
|
28.632 Points on scale
Standard Error 1.053 • Interval 1.053 to
|
|
Sum of Pain Intensity Differences From 0 to 2, 4, 6, 12 and 24 Hours Post-dose
0-12 hours post-dose
|
42.907 Points on scale
Standard Error 2.268 • Interval 2.268 to
|
7.003 Points on scale
Standard Error 3.883 • Interval 3.883 to
|
13.455 Points on scale
Standard Error 3.964 • Interval 3.964 to
|
44.207 Points on scale
Standard Error 2.266 • Interval 2.266 to
|
51.737 Points on scale
Standard Error 2.258 • Interval 2.258 to
|
|
Sum of Pain Intensity Differences From 0 to 2, 4, 6, 12 and 24 Hours Post-dose
0-24 hours post-dose
|
72.796 Points on scale
Standard Error 4.953 • Interval 4.953 to
|
12.533 Points on scale
Standard Error 8.481 • Interval 8.481 to
|
28.400 Points on scale
Standard Error 8.656 • Interval 8.656 to
|
77.596 Points on scale
Standard Error 4.949 • Interval 4.949 to
|
83.884 Points on scale
Standard Error 4.930 • Interval 4.93 to
|
SECONDARY outcome
Timeframe: up to 24 hours post-doseTotal 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.
Outcome measures
| Measure |
Naproxen Sodium 220 mg
n=147 Participants
Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.
|
Caffeine 100 mg
n=50 Participants
Participants received one tablet Caffeine 100 mg one tablet of placebo.
|
Placebo
n=49 Participants
Participants received two tablets of placebo.
|
Naproxen Sodium/ Caffeine 220/65 mg
n=147 Participants
Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.
|
Naproxen Sodium/Caffeine 2x220/65 mg
n=148 Participants
Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.
|
|---|---|---|---|---|---|
|
Total Pain Relief (TOTPAR) From 0 to 2, 4, 6, 8, 12 and 24 Hours Post-dose
0-2 hours post-dose
|
3.417 Points on scale
Standard Error 0.115 • Interval 0.115 to
|
1.047 Points on scale
Standard Error 0.196 • Interval 0.196 to
|
1.216 Points on scale
Standard Error 0.200 • Interval 0.2 to
|
3.284 Points on scale
Standard Error 0.114 • Interval 0.114 to
|
3.870 Points on scale
Standard Error 0.114 • Interval 0.114 to
|
|
Total Pain Relief (TOTPAR) From 0 to 2, 4, 6, 8, 12 and 24 Hours Post-dose
0-4 hours post-dose
|
8.102 Points on scale
Standard Error 0.287 • Interval 0.287 to
|
2.120 Points on scale
Standard Error 0.492 • Interval 0.492 to
|
3.168 Points on scale
Standard Error 0.502 • Interval 0.502 to
|
7.781 Points on scale
Standard Error 0.287 • Interval 0.287 to
|
9.118 Points on scale
Standard Error 0.286 • Interval 0.286 to
|
|
Total Pain Relief (TOTPAR) From 0 to 2, 4, 6, 8, 12 and 24 Hours Post-dose
0-6 hours post-dose
|
12.420 Points on scale
Standard Error 0.466 • Interval 0.466 to
|
3.228 Points on scale
Standard Error 0.798 • Interval 0.798 to
|
4.870 Points on scale
Standard Error 0.814 • Interval 0.814 to
|
12.098 Points on scale
Standard Error 0.465 • Interval 0.465 to
|
14.061 Points on scale
Standard Error 0.464 • Interval 0.464 to
|
|
Total Pain Relief (TOTPAR) From 0 to 2, 4, 6, 8, 12 and 24 Hours Post-dose
0-8 hours post-dose
|
16.225 Points on scale
Standard Error 0.645 • Interval 0.645 to
|
4.327 Points on scale
Standard Error 1.105 • Interval 1.105 to
|
6.552 Points on scale
Standard Error 1.128 • Interval 1.128 to
|
16.227 Points on scale
Standard Error 0.645 • Interval 0.645 to
|
18.625 Points on scale
Standard Error 0.642 • Interval 0.642 to
|
|
Total Pain Relief (TOTPAR) From 0 to 2, 4, 6, 8, 12 and 24 Hours Post-dose
0-12 hours post-dose
|
22.767 Points on scale
Standard Error 1.030 • Interval 1.03 to
|
6.264 Points on scale
Standard Error 1.764 • Interval 1.764 to
|
9.700 Points on scale
Standard Error 1.801 • Interval 1.801 to
|
23.512 Points on scale
Standard Error 1.029 • Interval 1.029 to
|
26.461 Points on scale
Standard Error 1.026 • Interval 1.026 to
|
|
Total Pain Relief (TOTPAR) From 0 to 2, 4, 6, 8, 12 and 24 Hours Post-dose
0-24 hours post-dose
|
39.127 Points on scale
Standard Error 2.283 • Interval 2.283 to
|
12.047 Points on scale
Standard Error 3.909 • Interval 3.909 to
|
18.975 Points on scale
Standard Error 3.990 • Interval 3.99 to
|
41.596 Points on scale
Standard Error 2.281 • Interval 2.281 to
|
43.908 Points on scale
Standard Error 2.272 • Interval 2.272 to
|
SECONDARY outcome
Timeframe: Up to 24 hours post-doseOutcome measures
| Measure |
Naproxen Sodium 220 mg
n=147 Participants
Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.
|
Caffeine 100 mg
n=50 Participants
Participants received one tablet Caffeine 100 mg one tablet of placebo.
|
Placebo
n=49 Participants
Participants received two tablets of placebo.
|
Naproxen Sodium/ Caffeine 220/65 mg
n=147 Participants
Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.
|
Naproxen Sodium/Caffeine 2x220/65 mg
n=148 Participants
Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.
|
|---|---|---|---|---|---|
|
Time to First Use of Rescue Medication
|
19.72 Hours
Interval 11.08 to
Insufficient number of participants with events.
|
2.07 Hours
Interval 1.72 to 2.75
|
2.65 Hours
Interval 1.67 to 7.28
|
NA Hours
Interval 17.33 to
Insufficient number of participants with events.
|
NA Hours
Interval 14.08 to
Insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 24 hours post-doseOutcome measures
| Measure |
Naproxen Sodium 220 mg
n=147 Participants
Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.
|
Caffeine 100 mg
n=50 Participants
Participants received one tablet Caffeine 100 mg one tablet of placebo.
|
Placebo
n=49 Participants
Participants received two tablets of placebo.
|
Naproxen Sodium/ Caffeine 220/65 mg
n=147 Participants
Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.
|
Naproxen Sodium/Caffeine 2x220/65 mg
n=148 Participants
Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.
|
|---|---|---|---|---|---|
|
The Cumulative Proportion of Participants Taking Rescue Medication Over the 24 Hour Period
0.5 hour
|
0 proportion
|
0 proportion
|
0 proportion
|
0 proportion
|
0 proportion
|
|
The Cumulative Proportion of Participants Taking Rescue Medication Over the 24 Hour Period
less or equal 1 hour
|
0.007 proportion
|
0.04 proportion
|
0.02 proportion
|
0.007 proportion
|
0 proportion
|
|
The Cumulative Proportion of Participants Taking Rescue Medication Over the 24 Hour Period
less or equal 1.5 hour
|
0.007 proportion
|
0.3 proportion
|
0.2 proportion
|
0.027 proportion
|
0.007 proportion
|
|
The Cumulative Proportion of Participants Taking Rescue Medication Over the 24 Hour Period
less or equal 2 hours
|
0.048 proportion
|
0.4 proportion
|
0.5 proportion
|
0.1 proportion
|
0.034 proportion
|
|
The Cumulative Proportion of Participants Taking Rescue Medication Over the 24 Hour Period
less or equal 3 hours
|
0.1 proportion
|
0.7 proportion
|
0.5 proportion
|
0.1 proportion
|
0.1 proportion
|
|
The Cumulative Proportion of Participants Taking Rescue Medication Over the 24 Hour Period
less or equal 4hours
|
0.1 proportion
|
0.7 proportion
|
0.6 proportion
|
0.2 proportion
|
0.1 proportion
|
|
The Cumulative Proportion of Participants Taking Rescue Medication Over the 24 Hour Period
less or equal 5 hours
|
0.1 proportion
|
0.7 proportion
|
0.6 proportion
|
0.2 proportion
|
0.1 proportion
|
|
The Cumulative Proportion of Participants Taking Rescue Medication Over the 24 Hour Period
less or equal 6 hours
|
0.2 proportion
|
0.8 proportion
|
0.6 proportion
|
0.2 proportion
|
0.1 proportion
|
|
The Cumulative Proportion of Participants Taking Rescue Medication Over the 24 Hour Period
less or equal 7 hours
|
0.2 proportion
|
0.8 proportion
|
0.6 proportion
|
0.2 proportion
|
0.1 proportion
|
|
The Cumulative Proportion of Participants Taking Rescue Medication Over the 24 Hour Period
less or equal 8 hours
|
0.3 proportion
|
0.8 proportion
|
0.6 proportion
|
0.2 proportion
|
0.1 proportion
|
|
The Cumulative Proportion of Participants Taking Rescue Medication Over the 24 Hour Period
less or equal 9 hours
|
0.3 proportion
|
0.8 proportion
|
0.7 proportion
|
0.3 proportion
|
0.2 proportion
|
|
The Cumulative Proportion of Participants Taking Rescue Medication Over the 24 Hour Period
less or equal 10 hours
|
0.4 proportion
|
0.8 proportion
|
0.7 proportion
|
0.3 proportion
|
0.2 proportion
|
|
The Cumulative Proportion of Participants Taking Rescue Medication Over the 24 Hour Period
less or equal 11 hours
|
0.4 proportion
|
0.8 proportion
|
0.7 proportion
|
0.4 proportion
|
0.3 proportion
|
|
The Cumulative Proportion of Participants Taking Rescue Medication Over the 24 Hour Period
less or equal 12 hours
|
0.4 proportion
|
0.8 proportion
|
0.7 proportion
|
0.4 proportion
|
0.3 proportion
|
|
The Cumulative Proportion of Participants Taking Rescue Medication Over the 24 Hour Period
less or equal 14 hours
|
0.4 proportion
|
0.8 proportion
|
0.7 proportion
|
0.4 proportion
|
0.4 proportion
|
|
The Cumulative Proportion of Participants Taking Rescue Medication Over the 24 Hour Period
less or equal 16 hours
|
0.5 proportion
|
0.8 proportion
|
0.7 proportion
|
0.4 proportion
|
0.4 proportion
|
|
The Cumulative Proportion of Participants Taking Rescue Medication Over the 24 Hour Period
less or equal 18 hours
|
0.5 proportion
|
0.8 proportion
|
0.7 proportion
|
0.4 proportion
|
0.4 proportion
|
|
The Cumulative Proportion of Participants Taking Rescue Medication Over the 24 Hour Period
less or equal 20 hours
|
0.5 proportion
|
0.8 proportion
|
0.7 proportion
|
0.4 proportion
|
0.4 proportion
|
|
The Cumulative Proportion of Participants Taking Rescue Medication Over the 24 Hour Period
less or equal 22 hours
|
0.5 proportion
|
0.8 proportion
|
0.7 proportion
|
0.4 proportion
|
0.4 proportion
|
|
The Cumulative Proportion of Participants Taking Rescue Medication Over the 24 Hour Period
less or equal 24 hours
|
0.5 proportion
|
0.8 proportion
|
0.7 proportion
|
0.4 proportion
|
0.4 proportion
|
SECONDARY outcome
Timeframe: Up to 24 hours post-doseOutcome measures
| Measure |
Naproxen Sodium 220 mg
n=147 Participants
Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.
|
Caffeine 100 mg
n=50 Participants
Participants received one tablet Caffeine 100 mg one tablet of placebo.
|
Placebo
n=49 Participants
Participants received two tablets of placebo.
|
Naproxen Sodium/ Caffeine 220/65 mg
n=147 Participants
Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.
|
Naproxen Sodium/Caffeine 2x220/65 mg
n=148 Participants
Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.
|
|---|---|---|---|---|---|
|
Time to First Perceptible Relief Measured by a Stopwatch
|
0.35 Hours
Interval 0.32 to 0.39
|
0.60 Hours
Interval 0.42 to 4.13
|
1.93 Hours
Interval 0.51 to
Insufficient number of participants with events.
|
0.39 Hours
Interval 0.33 to 0.42
|
0.35 Hours
Interval 0.32 to 0.41
|
SECONDARY outcome
Timeframe: Up to 24 hours post-dosemeaningful 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
Outcome measures
| Measure |
Naproxen Sodium 220 mg
n=147 Participants
Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.
|
Caffeine 100 mg
n=50 Participants
Participants received one tablet Caffeine 100 mg one tablet of placebo.
|
Placebo
n=49 Participants
Participants received two tablets of placebo.
|
Naproxen Sodium/ Caffeine 220/65 mg
n=147 Participants
Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.
|
Naproxen Sodium/Caffeine 2x220/65 mg
n=148 Participants
Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.
|
|---|---|---|---|---|---|
|
Time to Meaningful Relief Measured by a Stopwatch
|
0.79 Hours
Interval 0.67 to 0.93
|
NA Hours
Interval 2.24 to
Insufficient number of participants with events.
|
5.63 Hours
Interval 2.11 to 5.78
|
0.83 Hours
Interval 0.71 to 0.92
|
0.76 Hours
Interval 0.67 to 0.85
|
SECONDARY outcome
Timeframe: Up to 24 hours post-doseOutcome measures
| Measure |
Naproxen Sodium 220 mg
n=147 Participants
Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.
|
Caffeine 100 mg
n=50 Participants
Participants received one tablet Caffeine 100 mg one tablet of placebo.
|
Placebo
n=49 Participants
Participants received two tablets of placebo.
|
Naproxen Sodium/ Caffeine 220/65 mg
n=147 Participants
Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.
|
Naproxen Sodium/Caffeine 2x220/65 mg
n=148 Participants
Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.
|
|---|---|---|---|---|---|
|
Time to First Perceptible Relief Confirmed by Meaningful Relief Defined as the Time to Perceptible Pain Relief
|
0.79 Hours
Interval 0.67 to 0.93
|
NA Hours
Interval 2.24 to
Insufficient number of participants with events.
|
5.63 Hours
Interval 2.11 to 5.78
|
0.83 Hours
Interval 0.71 to 0.92
|
0.76 Hours
Interval 0.67 to 0.85
|
SECONDARY outcome
Timeframe: up to 24 hours post-dosePain 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
Outcome measures
| Measure |
Naproxen Sodium 220 mg
n=147 Participants
Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.
|
Caffeine 100 mg
n=50 Participants
Participants received one tablet Caffeine 100 mg one tablet of placebo.
|
Placebo
n=49 Participants
Participants received two tablets of placebo.
|
Naproxen Sodium/ Caffeine 220/65 mg
n=147 Participants
Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.
|
Naproxen Sodium/Caffeine 2x220/65 mg
n=148 Participants
Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.
|
|---|---|---|---|---|---|
|
Pain Intensity Difference (PID)
6 hours post-dose
|
3.8 Points on scale
Standard Deviation 2.74 • Interval 2.74 to
|
0.6 Points on scale
Standard Deviation 2.34 • Interval 2.34 to
|
1.2 Points on scale
Standard Deviation 3.01 • Interval 3.01 to
|
3.9 Points on scale
Standard Deviation 2.60 • Interval 2.6 to
|
4.6 Points on scale
Standard Deviation 2.48 • Interval 2.48 to
|
|
Pain Intensity Difference (PID)
7 hours post-dose
|
3.5 Points on scale
Standard Deviation 2.80 • Interval 2.8 to
|
0.6 Points on scale
Standard Deviation 2.30 • Interval 2.3 to
|
1.2 Points on scale
Standard Deviation 2.94 • Interval 2.94 to
|
3.8 Points on scale
Standard Deviation 2.61 • Interval 2.61 to
|
4.4 Points on scale
Standard Deviation 2.56 • Interval 2.56 to
|
|
Pain Intensity Difference (PID)
2 hours post-dose
|
4.7 Points on scale
Standard Deviation 2.30 • Interval 2.3 to
|
0.7 Points on scale
Standard Deviation 1.99 • Interval 1.99 to
|
0.9 Points on scale
Standard Deviation 2.48 • Interval 2.48 to
|
4.4 Points on scale
Standard Deviation 2.56 • Interval 2.56 to
|
5.2 Points on scale
Standard Deviation 2.12 • Interval 2.12 to
|
|
Pain Intensity Difference (PID)
3 hours post-dose
|
4.4 Points on scale
Standard Deviation 2.45 • Interval 2.45 to
|
0.4 Points on scale
Standard Deviation 1.94 • Interval 1.94 to
|
1.1 Points on scale
Standard Deviation 2.64 • Interval 2.64 to
|
4.3 Points on scale
Standard Deviation 2.55 • Interval 2.55 to
|
5.2 Points on scale
Standard Deviation 2.28 • Interval 2.28 to
|
|
Pain Intensity Difference (PID)
4 hours post-dose
|
4.3 Points on scale
Standard Deviation 2.65 • Interval 2.65 to
|
0.6 Points on scale
Standard Deviation 2.19 • Interval 2.19 to
|
1.4 Points on scale
Standard Deviation 2.99 • Interval 2.99 to
|
4.2 Points on scale
Standard Deviation 2.54 • Interval 2.54 to
|
5.1 Points on scale
Standard Deviation 2.47 • Interval 2.47 to
|
|
Pain Intensity Difference (PID)
9 hours post dose
|
3.3 Points on scale
Standard Deviation 2.96 • Interval 2.96 to
|
0.6 Points on scale
Standard Deviation 2.47 • Interval 2.47 to
|
1.3 Points on scale
Standard Deviation 3.15 • Interval 3.15 to
|
3.5 Points on scale
Standard Deviation 2.72 • Interval 2.72 to
|
3.9 Points on scale
Standard Deviation 2.68 • Interval 2.68 to
|
|
Pain Intensity Difference (PID)
16 hours post-dose
|
2.4 Points on scale
Standard Deviation 3.04 • Interval 3.04 to
|
0.4 Points on scale
Standard Deviation 2.27 • Interval 2.27 to
|
1.2 Points on scale
Standard Deviation 3.21 • Interval 3.21 to
|
2.6 Points on scale
Standard Deviation 2.99 • Interval 2.99 to
|
2.7 Points on scale
Standard Deviation 2.85 • Interval 2.85 to
|
|
Pain Intensity Difference (PID)
5 hours post-dose
|
4.1 Points on scale
Standard Deviation 2.73 • Interval 2.73 to
|
0.5 Points on scale
Standard Deviation 2.11 • Interval 2.11 to
|
1.2 Points on scale
Standard Deviation 2.84 • Interval 2.84 to
|
4.0 Points on scale
Standard Deviation 2.55 • Interval 2.55 to
|
4.8 Points on scale
Standard Deviation 2.46 • Interval 2.46 to
|
|
Pain Intensity Difference (PID)
Baseline
|
7.8 Points on scale
Standard Deviation 1.21 • Interval 1.21 to
|
7.7 Points on scale
Standard Deviation 1.39 • Interval 1.39 to
|
7.7 Points on scale
Standard Deviation 0.99 • Interval 0.99 to
|
7.6 Points on scale
Standard Deviation 1.22 • Interval 1.22 to
|
7.6 Points on scale
Standard Deviation 1.20 • Interval 1.2 to
|
|
Pain Intensity Difference (PID)
0.5 hours post-dose
|
2.4 Points on scale
Standard Deviation 1.98 • Interval 1.98 to
|
1.0 Points on scale
Standard Deviation 1.38 • Interval 1.38 to
|
0.6 Points on scale
Standard Deviation 1.18 • Interval 1.18 to
|
1.8 Points on scale
Standard Deviation 1.89 • Interval 1.89 to
|
2.3 Points on scale
Standard Deviation 1.91 • Interval 1.91 to
|
|
Pain Intensity Difference (PID)
1 hour post-dose
|
3.7 Points on scale
Standard Deviation 2.23 • Interval 2.23 to
|
0.8 Points on scale
Standard Deviation 1.67 • Interval 1.67 to
|
0.7 Points on scale
Standard Deviation 1.89 • Interval 1.89 to
|
3.4 Points on scale
Standard Deviation 2.40 • Interval 2.4 to
|
4.3 Points on scale
Standard Deviation 2.18 • Interval 2.18 to
|
|
Pain Intensity Difference (PID)
1.5 hours post-dose
|
4.3 Points on scale
Standard Deviation 2.27 • Interval 2.27 to
|
0.6 Points on scale
Standard Deviation 1.68 • Interval 1.68 to
|
0.6 Points on scale
Standard Deviation 2.17 • Interval 2.17 to
|
4.0 Points on scale
Standard Deviation 2.40 • Interval 2.4 to
|
4.9 Points on scale
Standard Deviation 2.13 • Interval 2.13 to
|
|
Pain Intensity Difference (PID)
8 hours post-dose
|
3.3 Points on scale
Standard Deviation 2.88 • Interval 2.88 to
|
0.6 Points on scale
Standard Deviation 2.30 • Interval 2.3 to
|
1.2 Points on scale
Standard Deviation 3.00 • Interval 3.0 to
|
3.6 Points on scale
Standard Deviation 2.63 • Interval 2.63 to
|
4.1 Points on scale
Standard Deviation 2.60 • Interval 2.6 to
|
|
Pain Intensity Difference (PID)
10 hours post-dose
|
3.1 Points on scale
Standard Deviation 3.03 • Interval 3.03 to
|
0.4 Points on scale
Standard Deviation 2.25 • Interval 2.25 to
|
1.3 Points on scale
Standard Deviation 3.24 • Interval 3.24 to
|
3.3 Points on scale
Standard Deviation 2.78 • Interval 2.78 to
|
3.8 Points on scale
Standard Deviation 2.81 • Interval 2.81 to
|
|
Pain Intensity Difference (PID)
11 hours post-dose
|
2.9 Points on scale
Standard Deviation 3.02 • Interval 3.02 to
|
0.4 Points on scale
Standard Deviation 2.34 • Interval 2.34 to
|
1.2 Points on scale
Standard Deviation 3.23 • Interval 3.23 to
|
3.1 Points on scale
Standard Deviation 2.84 • Interval 2.84 to
|
3.6 Points on scale
Standard Deviation 2.86 • Interval 2.86 to
|
|
Pain Intensity Difference (PID)
12 hours post-dose
|
2.8 Points on scale
Standard Deviation 3.07 • Interval 3.07 to
|
0.4 Points on scale
Standard Deviation 2.29 • Interval 2.29 to
|
1.3 Points on scale
Standard Deviation 3.32 • Interval 3.32 to
|
2.9 Points on scale
Standard Deviation 2.90 • Interval 2.9 to
|
3.2 Points on scale
Standard Deviation 2.90 • Interval 2.9 to
|
|
Pain Intensity Difference (PID)
14 hours post-dose
|
2.6 Points on scale
Standard Deviation 3.04 • Interval 3.04 to
|
0.4 Points on scale
Standard Deviation 2.20 • Interval 2.2 to
|
1.3 Points on scale
Standard Deviation 3.32 • Interval 3.32 to
|
2.9 Points on scale
Standard Deviation 2.97 • Interval 2.97 to
|
2.9 Points on scale
Standard Deviation 3.01 • Interval 3.01 to
|
|
Pain Intensity Difference (PID)
18 hours post-dose
|
2.4 Points on scale
Standard Deviation 3.02 • Interval 3.02 to
|
0.4 Points on scale
Standard Deviation 2.27 • Interval 2.27 to
|
1.2 Points on scale
Standard Deviation 3.22 • Interval 3.22 to
|
2.7 Points on scale
Standard Deviation 3.05 • Interval 3.05 to
|
2.6 Points on scale
Standard Deviation 2.83 • Interval 2.83 to
|
|
Pain Intensity Difference (PID)
20 hours post-dose
|
2.5 Points on scale
Standard Deviation 3.06 • Interval 3.06 to
|
0.4 Points on scale
Standard Deviation 2.33 • Interval 2.33 to
|
1.2 Points on scale
Standard Deviation 3.28 • Interval 3.28 to
|
2.7 Points on scale
Standard Deviation 3.07 • Interval 3.07 to
|
2.6 Points on scale
Standard Deviation 2.81 • Interval 2.81 to
|
|
Pain Intensity Difference (PID)
22 hours post-dose
|
2.6 Points on scale
Standard Deviation 3.14 • Interval 3.14 to
|
0.5 Points on scale
Standard Deviation 2.55 • Interval 2.55 to
|
1.4 Points on scale
Standard Deviation 3.51 • Interval 3.51 to
|
2.8 Points on scale
Standard Deviation 3.19 • Interval 3.19 to
|
2.7 Points on scale
Standard Deviation 2.85 • Interval 2.85 to
|
|
Pain Intensity Difference (PID)
24 hours post-dose
|
2.6 Points on scale
Standard Deviation 3.20 • Interval 3.2 to
|
0.6 Points on scale
Standard Deviation 2.62 • Interval 2.62 to
|
1.5 Points on scale
Standard Deviation 3.63 • Interval 3.63 to
|
2.9 Points on scale
Standard Deviation 3.19 • Interval 3.19 to
|
2.8 Points on scale
Standard Deviation 2.92 • Interval 2.92 to
|
SECONDARY outcome
Timeframe: Up to 24 hours post-dosePain Relief Score (PRS): 0 = No Relief; 1 = A Little Relief; 2 = Some Relief; 3 = A Lot of Relief; 4 = Complete Relief.
Outcome measures
| Measure |
Naproxen Sodium 220 mg
n=147 Participants
Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.
|
Caffeine 100 mg
n=50 Participants
Participants received one tablet Caffeine 100 mg one tablet of placebo.
|
Placebo
n=49 Participants
Participants received two tablets of placebo.
|
Naproxen Sodium/ Caffeine 220/65 mg
n=147 Participants
Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.
|
Naproxen Sodium/Caffeine 2x220/65 mg
n=148 Participants
Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.
|
|---|---|---|---|---|---|
|
Pain Relief Score
24 hours post-dose
|
1.4 Points on scale
Standard Deviation 1.56 • Interval 1.56 to
|
0.5 Points on scale
Standard Deviation 1.22 • Interval 1.22 to
|
0.9 Points on scale
Standard Deviation 1.51 • Interval 1.51 to
|
1.6 Points on scale
Standard Deviation 1.53 • Interval 1.53 to
|
1.6 Points on scale
Standard Deviation 1.51 • Interval 1.51 to
|
|
Pain Relief Score
0.5 hours post-dose
|
1.5 Points on scale
Standard Deviation 0.97 • Interval 0.97 to
|
0.7 Points on scale
Standard Deviation 0.72 • Interval 0.72 to
|
0 Points on scale
Standard Deviation 0.65 • Interval 0.65 to
|
1.3 Points on scale
Standard Deviation 0.93 • Interval 0.93 to
|
1.5 Points on scale
Standard Deviation 1.01 • Interval 1.01 to
|
|
Pain Relief Score
1 hour post-dose
|
2.1 Points on scale
Standard Deviation 0.99 • Interval 0.99 to
|
0.7 Points on scale
Standard Deviation 0.9 • Interval 0.9 to
|
0.8 Points on scale
Standard Deviation 0.96 • Interval 0.96 to
|
2.0 Points on scale
Standard Deviation 1.04 • Interval 1.04 to
|
2.4 Points on scale
Standard Deviation 0.9 • Interval 0.9 to
|
|
Pain Relief Score
1.5 hours post-dose
|
2.3 Points on scale
Standard Deviation 0.94 • Interval 0.94 to
|
0.6 Points on scale
Standard Deviation 0.88 • Interval 0.88 to
|
0.8 Points on scale
Standard Deviation 1.04 • Interval 1.04 to
|
2.3 Points on scale
Standard Deviation 1.07 • Interval 1.07 to
|
2.6 Points on scale
Standard Deviation 0.87 • Interval 0.87 to
|
|
Pain Relief Score
2 hours post-dose
|
2.5 Points on scale
Standard Deviation 0.99 • Interval 0.99 to
|
0.7 Points on scale
Standard Deviation 0.95 • Interval 0.95 to
|
0.9 Points on scale
Standard Deviation 1.17 • Interval 1.17 to
|
2.3 Points on scale
Standard Deviation 1.13 • Interval 1.13 to
|
2.7 Points on scale
Standard Deviation 0.93 • Interval 0.93 to
|
|
Pain Relief Score
3 hours post-dose
|
2.4 Points on scale
Standard Deviation 1.11 • Interval 1.11 to
|
0.5 Points on scale
Standard Deviation 0.93 • Interval 0.93 to
|
1.0 Points on scale
Standard Deviation 1.25 • Interval 1.25 to
|
2.3 Points on scale
Standard Deviation 1.19 • Interval 1.19 to
|
2.7 Points on scale
Standard Deviation 1.06 • Interval 1.06 to
|
|
Pain Relief Score
4 hours post-dose
|
2.3 Points on scale
Standard Deviation 1.2 • Interval 1.2 to
|
0.6 Points on scale
Standard Deviation 0.99 • Interval 0.99 to
|
1.0 Points on scale
Standard Deviation 1.35 • Interval 1.35 to
|
2.2 Points on scale
Standard Deviation 1.2 • Interval 1.2 to
|
2.6 Points on scale
Standard Deviation 1.18 • Interval 1.18 to
|
|
Pain Relief Score
5 hours post-dose
|
2.3 Points on scale
Standard Deviation 1.28 • Interval 1.28 to
|
0.5 Points on scale
Standard Deviation 1.03 • Interval 1.03 to
|
0.8 Points on scale
Standard Deviation 1.17 • Interval 1.17 to
|
2.1 Points on scale
Standard Deviation 1.24 • Interval 1.24 to
|
2.5 Points on scale
Standard Deviation 1.13 • Interval 1.13 to
|
|
Pain Relief Score
6 hours post-dose
|
2.1 Points on scale
Standard Deviation 1.28 • Interval 1.28 to
|
0.6 Points on scale
Standard Deviation 1.07 • Interval 1.07 to
|
0.9 Points on scale
Standard Deviation 1.3 • Interval 1.3 to
|
2.2 Points on scale
Standard Deviation 1.26 • Interval 1.26 to
|
2.5 Points on scale
Standard Deviation 1.12 • Interval 1.12 to
|
|
Pain Relief Score
7 hours post-dose
|
2.0 Points on scale
Standard Deviation 1.28 • Interval 1.28 to
|
0.6 Points on scale
Standard Deviation 1.07 • Interval 1.07 to
|
0.9 Points on scale
Standard Deviation 1.28 • Interval 1.28 to
|
2.1 Points on scale
Standard Deviation 1.27 • Interval 1.27 to
|
2.3 Points on scale
Standard Deviation 1.16 • Interval 1.16 to
|
|
Pain Relief Score
8 hours post-dose
|
1.8 Points on scale
Standard Deviation 1.36 • Interval 1.36 to
|
0.5 Points on scale
Standard Deviation 1.03 • Interval 1.03 to
|
0.8 Points on scale
Standard Deviation 1.21 • Interval 1.21 to
|
2.1 Points on scale
Standard Deviation 1.28 • Interval 1.28 to
|
2.2 Points on scale
Standard Deviation 1.23 • Interval 1.23 to
|
|
Pain Relief Score
9 hours post-dose
|
1.8 Points on scale
Standard Deviation 1.39 • Interval 1.39 to
|
0.5 Points on scale
Standard Deviation 1.02 • Interval 1.02 to
|
0.8 Points on scale
Standard Deviation 1.28 • Interval 1.28 to
|
2.0 Points on scale
Standard Deviation 1.33 • Interval 1.33 to
|
2.1 Points on scale
Standard Deviation 1.28 • Interval 1.28 to
|
|
Pain Relief Score
10 hours post-dose
|
1.7 Points on scale
Standard Deviation 1.42 • Interval 1.42 to
|
0.5 Points on scale
Standard Deviation 1.05 • Interval 1.05 to
|
0.8 Points on scale
Standard Deviation 1.31 • Interval 1.31 to
|
1.9 Points on scale
Standard Deviation 1.35 • Interval 1.35 to
|
2.1 Points on scale
Standard Deviation 1.35 • Interval 1.35 to
|
|
Pain Relief Score
11 hours post-dose
|
1.6 Points on scale
Standard Deviation 1.45 • Interval 1.45 to
|
0.5 Points on scale
Standard Deviation 1.07 • Interval 1.07 to
|
0.8 Points on scale
Standard Deviation 1.34 • Interval 1.34 to
|
1.8 Points on scale
Standard Deviation 1.38 • Interval 1.38 to
|
2.0 Points on scale
Standard Deviation 1.41 • Interval 1.41 to
|
|
Pain Relief Score
12 hours post-dose
|
1.5 Points on scale
Standard Deviation 1.47 • Interval 1.47 to
|
0.5 Points on scale
Standard Deviation 1.07 • Interval 1.07 to
|
0.8 Points on scale
Standard Deviation 1.34 • Interval 1.34 to
|
1.7 Points on scale
Standard Deviation 1.4 • Interval 1.4 to
|
1.8 Points on scale
Standard Deviation 1.46 • Interval 1.46 to
|
|
Pain Relief Score
14 hours post-dose
|
1.4 Points on scale
Standard Deviation 1.46 • Interval 1.46 to
|
0.5 Points on scale
Standard Deviation 1.03 • Interval 1.03 to
|
0.8 Points on scale
Standard Deviation 1.29 • Interval 1.29 to
|
1.6 Points on scale
Standard Deviation 1.44 • Interval 1.44 to
|
1.6 Points on scale
Standard Deviation 1.51 • Interval 1.51 to
|
|
Pain Relief Score
16 hours post-dose
|
1.3 Points on scale
Standard Deviation 1.44 • Interval 1.44 to
|
0.5 Points on scale
Standard Deviation 1.03 • Interval 1.03 to
|
0.7 Points on scale
Standard Deviation 1.25 • Interval 1.25 to
|
1.5 Points on scale
Standard Deviation 1.45 • Interval 1.45 to
|
1.5 Points on scale
Standard Deviation 1.46 • Interval 1.46 to
|
|
Pain Relief Score
18 hours post-dose
|
1.3 Points on scale
Standard Deviation 1.43 • Interval 1.43 to
|
0.5 Points on scale
Standard Deviation 1.03 • Interval 1.03 to
|
0.7 Points on scale
Standard Deviation 1.25 • Interval 1.25 to
|
1.5 Points on scale
Standard Deviation 1.45 • Interval 1.45 to
|
1.4 Points on scale
Standard Deviation 1.44 • Interval 1.44 to
|
|
Pain Relief Score
20 hours post-dose
|
1.3 Points on scale
Standard Deviation 1.46 • Interval 1.46 to
|
0.5 Points on scale
Standard Deviation 1.03 • Interval 1.03 to
|
0.8 Points on scale
Standard Deviation 1.31 • Interval 1.31 to
|
1.5 Points on scale
Standard Deviation 1.44 • Interval 1.44 to
|
1.4 Points on scale
Standard Deviation 1.44 • Interval 1.44 to
|
|
Pain Relief Score
22 hours post-dose
|
1.4 Points on scale
Standard Deviation 1.51 • Interval 1.51 to
|
0.5 Points on scale
Standard Deviation 1.18 • Interval 1.18 to
|
0.9 Points on scale
Standard Deviation 1.46 • Interval 1.46 to
|
1.5 Points on scale
Standard Deviation 1.51 • Interval 1.51 to
|
1.5 Points on scale
Standard Deviation 1.50 • Interval 1.5 to
|
SECONDARY outcome
Timeframe: Up to 24 hours post-doseThe Peak Pain Intensity (peak PID) refers to the maximum change in pain intensity from baseline observed at any post-dose time point 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. Participants record their pain intensity assessment in the time frame points and the highest value is identified as the Peak Pain Intensity. A high peak pain intensuty (higher value on NRS) indicates severe pain and a less effective analgesic response, and a lower value signifies better pain control and a more effective response.
Outcome measures
| Measure |
Naproxen Sodium 220 mg
n=147 Participants
Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.
|
Caffeine 100 mg
n=50 Participants
Participants received one tablet Caffeine 100 mg one tablet of placebo.
|
Placebo
n=49 Participants
Participants received two tablets of placebo.
|
Naproxen Sodium/ Caffeine 220/65 mg
n=147 Participants
Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.
|
Naproxen Sodium/Caffeine 2x220/65 mg
n=148 Participants
Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.
|
|---|---|---|---|---|---|
|
Peak Pain Intensity Difference (PID)
|
6.22 Points on scale
Standard Error 0.11 • Interval 0.11 to
|
6.30 Points on scale
Standard Error 0.18 • Interval 0.18 to
|
6.33 Points on scale
Standard Error 0.19 • Interval 0.19 to
|
6.12 Points on scale
Standard Error 0.11 • Interval 0.11 to
|
6.26 Points on scale
Standard Error 0.11 • Interval 0.11 to
|
SECONDARY outcome
Timeframe: Up to 24 hours post-doseNumber of participants with pain relief score 4, 3, 2, 1. The Peak Pain Relief Score refers to the highest level of pain relief a participant reported at any time point during the study period. It provides an overview of the maximum effectiveness of the treatment at any given point during the observation period using the Categorical Pain Relief Scale which 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. A high socre closer indicates significant pain relief and reflects the effectiveness of the analgesic treatment. A score closer to 0 indicates little to no pain relief and suggests limited treatment efficacy.
Outcome measures
| Measure |
Naproxen Sodium 220 mg
n=147 Participants
Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.
|
Caffeine 100 mg
n=50 Participants
Participants received one tablet Caffeine 100 mg one tablet of placebo.
|
Placebo
n=49 Participants
Participants received two tablets of placebo.
|
Naproxen Sodium/ Caffeine 220/65 mg
n=147 Participants
Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.
|
Naproxen Sodium/Caffeine 2x220/65 mg
n=148 Participants
Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.
|
|---|---|---|---|---|---|
|
Number of Participants With Certain Peak Pain Relief Score
Pain relief score 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Certain Peak Pain Relief Score
Pain relief score 4
|
36 Participants
|
15 Participants
|
15 Participants
|
31 Participants
|
47 Participants
|
|
Number of Participants With Certain Peak Pain Relief Score
Pain relief score 3
|
102 Participants
|
31 Participants
|
29 Participants
|
101 Participants
|
85 Participants
|
|
Number of Participants With Certain Peak Pain Relief Score
Pain relief score 2
|
9 Participants
|
4 Participants
|
5 Participants
|
14 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Up to 24 hours post-doseOutcome measures
| Measure |
Naproxen Sodium 220 mg
n=147 Participants
Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.
|
Caffeine 100 mg
n=50 Participants
Participants received one tablet Caffeine 100 mg one tablet of placebo.
|
Placebo
n=49 Participants
Participants received two tablets of placebo.
|
Naproxen Sodium/ Caffeine 220/65 mg
n=147 Participants
Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.
|
Naproxen Sodium/Caffeine 2x220/65 mg
n=148 Participants
Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.
|
|---|---|---|---|---|---|
|
Cumulative Percent of Participants With 'at Least a 2-point PID' Over Time
less or equal 10 hours
|
100 percentage
|
100 percentage
|
98.0 percentage
|
99.3 percentage
|
99.3 percentage
|
|
Cumulative Percent of Participants With 'at Least a 2-point PID' Over Time
less or equal 11 hours
|
100 percentage
|
100 percentage
|
98.0 percentage
|
99.3 percentage
|
99.3 percentage
|
|
Cumulative Percent of Participants With 'at Least a 2-point PID' Over Time
less or equal 12 hours
|
100 percentage
|
100 percentage
|
98.0 percentage
|
100 percentage
|
99.3 percentage
|
|
Cumulative Percent of Participants With 'at Least a 2-point PID' Over Time
less or equal 14 hours
|
100 percentage
|
100 percentage
|
98.0 percentage
|
100 percentage
|
99.3 percentage
|
|
Cumulative Percent of Participants With 'at Least a 2-point PID' Over Time
less or equal 16 hours
|
100 percentage
|
100 percentage
|
98.0 percentage
|
100 percentage
|
99.3 percentage
|
|
Cumulative Percent of Participants With 'at Least a 2-point PID' Over Time
less or equal 3 hours
|
98.0 percentage
|
86.0 percentage
|
87.8 percentage
|
98.0 percentage
|
99.3 percentage
|
|
Cumulative Percent of Participants With 'at Least a 2-point PID' Over Time
less or equal 4 hours
|
99.3 percentage
|
94.0 percentage
|
95.9 percentage
|
98.6 percentage
|
99.3 percentage
|
|
Cumulative Percent of Participants With 'at Least a 2-point PID' Over Time
less or equal 18 hours
|
100 percentage
|
100 percentage
|
98.0 percentage
|
100 percentage
|
99.3 percentage
|
|
Cumulative Percent of Participants With 'at Least a 2-point PID' Over Time
0.5 hour post-dose
|
60.5 percentage
|
32.0 percentage
|
18.4 percentage
|
50.3 percentage
|
62.8 percentage
|
|
Cumulative Percent of Participants With 'at Least a 2-point PID' Over Time
less or equal 1 hour
|
86.4 percentage
|
40.0 percentage
|
26.5 percentage
|
78.2 percentage
|
86.5 percentage
|
|
Cumulative Percent of Participants With 'at Least a 2-point PID' Over Time
less or equal 1.5 hour
|
92.5 percentage
|
46.0 percentage
|
40.8 percentage
|
87.1 percentage
|
94.6 percentage
|
|
Cumulative Percent of Participants With 'at Least a 2-point PID' Over Time
less or equal 2 hours
|
94.6 percentage
|
64.0 percentage
|
71.4 percentage
|
92.5 percentage
|
98.0 percentage
|
|
Cumulative Percent of Participants With 'at Least a 2-point PID' Over Time
less or equal 5 hours
|
99.3 percentage
|
98.0 percentage
|
98.0 percentage
|
98.6 percentage
|
99.3 percentage
|
|
Cumulative Percent of Participants With 'at Least a 2-point PID' Over Time
less or equal 6 hours
|
99.3 percentage
|
100 percentage
|
98.0 percentage
|
99.3 percentage
|
99.3 percentage
|
|
Cumulative Percent of Participants With 'at Least a 2-point PID' Over Time
less or equal 7 hours
|
99.3 percentage
|
100 percentage
|
98.0 percentage
|
99.3 percentage
|
99.3 percentage
|
|
Cumulative Percent of Participants With 'at Least a 2-point PID' Over Time
less or equal 8 hours
|
100 percentage
|
100 percentage
|
98.0 percentage
|
99.3 percentage
|
99.3 percentage
|
|
Cumulative Percent of Participants With 'at Least a 2-point PID' Over Time
less or equal 9 hours
|
100 percentage
|
100 percentage
|
98.0 percentage
|
99.3 percentage
|
99.3 percentage
|
|
Cumulative Percent of Participants With 'at Least a 2-point PID' Over Time
less or equal 20 hours
|
100 percentage
|
100 percentage
|
98.0 percentage
|
100 percentage
|
99.3 percentage
|
|
Cumulative Percent of Participants With 'at Least a 2-point PID' Over Time
less or equal 22 hours
|
100 percentage
|
100 percentage
|
98.0 percentage
|
100 percentage
|
99.3 percentage
|
|
Cumulative Percent of Participants With 'at Least a 2-point PID' Over Time
less or equal 24 hours
|
100 percentage
|
100 percentage
|
98.0 percentage
|
100 percentage
|
99.3 percentage
|
SECONDARY outcome
Timeframe: 24 hours post-doseNumber of participants with overall rating poor, fair, good, very good, excellent 24 hour post-dose
Outcome measures
| Measure |
Naproxen Sodium 220 mg
n=147 Participants
Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.
|
Caffeine 100 mg
n=50 Participants
Participants received one tablet Caffeine 100 mg one tablet of placebo.
|
Placebo
n=47 Participants
Participants received two tablets of placebo.
|
Naproxen Sodium/ Caffeine 220/65 mg
n=147 Participants
Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.
|
Naproxen Sodium/Caffeine 2x220/65 mg
n=146 Participants
Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.
|
|---|---|---|---|---|---|
|
Global Assessment of Pain Relief of the Investigational Product
poor
|
11 Participants
|
26 Participants
|
27 Participants
|
16 Participants
|
5 Participants
|
|
Global Assessment of Pain Relief of the Investigational Product
fair
|
12 Participants
|
10 Participants
|
5 Participants
|
10 Participants
|
12 Participants
|
|
Global Assessment of Pain Relief of the Investigational Product
good
|
38 Participants
|
8 Participants
|
3 Participants
|
35 Participants
|
23 Participants
|
|
Global Assessment of Pain Relief of the Investigational Product
very good
|
58 Participants
|
5 Participants
|
9 Participants
|
56 Participants
|
69 Participants
|
|
Global Assessment of Pain Relief of the Investigational Product
excellent
|
28 Participants
|
1 Participants
|
3 Participants
|
30 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Up to 5 days post-doseNumber of participants with at least one treatment emergent adverse event
Outcome measures
| Measure |
Naproxen Sodium 220 mg
n=147 Participants
Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.
|
Caffeine 100 mg
n=50 Participants
Participants received one tablet Caffeine 100 mg one tablet of placebo.
|
Placebo
n=49 Participants
Participants received two tablets of placebo.
|
Naproxen Sodium/ Caffeine 220/65 mg
n=147 Participants
Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.
|
Naproxen Sodium/Caffeine 2x220/65 mg
n=148 Participants
Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
23 Participants
|
3 Participants
|
4 Participants
|
19 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 5 days post-doseOutcome measures
| Measure |
Naproxen Sodium 220 mg
n=147 Participants
Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.
|
Caffeine 100 mg
n=50 Participants
Participants received one tablet Caffeine 100 mg one tablet of placebo.
|
Placebo
n=49 Participants
Participants received two tablets of placebo.
|
Naproxen Sodium/ Caffeine 220/65 mg
n=147 Participants
Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.
|
Naproxen Sodium/Caffeine 2x220/65 mg
n=148 Participants
Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.
|
|---|---|---|---|---|---|
|
Number of Participants With Significant Changes in Vital Signs Since Baseline
Bradycardia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Significant Changes in Vital Signs Since Baseline
Tachycardia
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Significant Changes in Vital Signs Since Baseline
Hypertension
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Significant Changes in Vital Signs Since Baseline
Hypotension
|
4 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
Adverse Events
Naproxen Sodium/ Caffeine 220/65 mg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Naproxen Sodium/Caffeine 2x220/65 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Caffeine 100 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Naproxen Sodium 220 mg
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Naproxen Sodium/ Caffeine 220/65 mg
n=147 participants at risk
Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo.
|
Naproxen Sodium/Caffeine 2x220/65 mg
n=148 participants at risk
Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg.
|
Placebo
n=49 participants at risk
Participants received two tablets of placebo.
|
Caffeine 100 mg
n=50 participants at risk
Participants received one tablet Caffeine 100 mg one tablet of placebo.
|
Naproxen Sodium 220 mg
n=147 participants at risk
Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.68%
1/148 • Number of events 1 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/49 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/50 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
Infections and infestations
Alveolar osteitis
|
2.7%
4/147 • Number of events 4 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/148 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/49 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/50 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.68%
1/147 • Number of events 1 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.68%
1/147 • Number of events 1 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/148 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/49 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
2.0%
1/50 • Number of events 1 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/148 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/49 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/50 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.68%
1/147 • Number of events 1 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.68%
1/148 • Number of events 1 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/49 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/50 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
Nervous system disorders
Dizziness
|
2.0%
3/147 • Number of events 4 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
1.4%
2/148 • Number of events 2 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
2.0%
1/49 • Number of events 1 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/50 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
4.8%
7/147 • Number of events 7 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.68%
1/147 • Number of events 1 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.68%
1/148 • Number of events 1 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/49 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/50 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/148 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/49 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
2.0%
1/50 • Number of events 1 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
Nervous system disorders
Headache
|
2.7%
4/147 • Number of events 4 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/148 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
6.1%
3/49 • Number of events 3 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
2.0%
1/50 • Number of events 2 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.68%
1/147 • Number of events 1 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.68%
1/148 • Number of events 1 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/49 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/50 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
General disorders
Chills
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/148 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/49 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/50 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.68%
1/147 • Number of events 1 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
Infections and infestations
Candida infection
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/148 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
2.0%
1/49 • Number of events 1 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/50 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
Cardiac disorders
Bradycardia
|
0.68%
1/147 • Number of events 1 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/148 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/49 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/50 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
Vascular disorders
Hypertension
|
1.4%
2/147 • Number of events 2 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/148 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/49 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/50 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
Vascular disorders
Hypotension
|
0.68%
1/147 • Number of events 1 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.68%
1/148 • Number of events 1 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/49 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/50 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
2.0%
3/147 • Number of events 3 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/148 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/49 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/50 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.68%
1/147 • Number of events 1 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
Gastrointestinal disorders
Nausea
|
0.68%
1/147 • Number of events 1 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
4.1%
6/148 • Number of events 7 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/49 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/50 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
3.4%
5/147 • Number of events 5 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/148 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/49 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/50 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
1.4%
2/147 • Number of events 2 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
General disorders
Pain
|
0.68%
1/147 • Number of events 1 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/148 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/49 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/50 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/148 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/49 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/50 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.68%
1/147 • Number of events 1 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.68%
1/148 • Number of events 1 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/49 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/50 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.68%
1/147 • Number of events 1 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/148 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/49 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/50 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
Nervous system disorders
Syncope
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
1.4%
2/148 • Number of events 2 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/49 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/50 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
Cardiac disorders
Tachycardia
|
0.68%
1/147 • Number of events 1 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/148 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/49 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/50 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
2.0%
3/147 • Number of events 3 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/148 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/49 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/50 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
1.4%
2/147 • Number of events 2 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
Gastrointestinal disorders
Toothache
|
0.68%
1/147 • Number of events 1 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/148 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/49 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/50 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/148 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/49 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/50 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
6.1%
9/147 • Number of events 12 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
|
General disorders
Pyrexia
|
0.68%
1/147 • Number of events 1 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/148 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/49 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/50 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
0.00%
0/147 • All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER