Trial Outcomes & Findings for Acetaminophen/Naproxen Sodium Dose Ranging Study (NCT NCT04447040)
NCT ID: NCT04447040
Last Updated: 2025-03-24
Results Overview
Time weighted sum of the pain intensity difference (SPID) score is derived from pain intensity difference (PID) score. Pain intensity-numerical rating scale (PI-NRS) was used to assess pain intensity on scale ranged from 0 (no pain) to 10 (very severe pain), higher score indicated severe pain intensity. PID score was the difference between baseline pain intensity and pain intensity at assessment timepoint (12 hours). The SPID scores were derived by first multiplying each PID score by the time from the previous time point and adding these time weighted PID scores together over the interval from 0 to 12 hours. The possible range of SPID for 0 to 12 hours was from -120 to 120. A higher value of SPID indicated greater pain relief.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
304 participants
Primary outcome timeframe
Baseline (0 hour) up to 12 hours post-dose on Day 1
Results posted on
2025-03-24
Participant Flow
Participant milestones
| Measure |
Placebo
Participants who underwent dental extraction of three or four third molars received a single oral dose of two placebo tablets on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose A
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose A orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose B
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose B orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose C
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose C orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose D
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose D orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose E
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose E orally on Day 1 post dental extraction.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
53
|
49
|
53
|
52
|
51
|
46
|
|
Overall Study
COMPLETED
|
51
|
47
|
49
|
48
|
50
|
43
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
4
|
4
|
1
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Participants who underwent dental extraction of three or four third molars received a single oral dose of two placebo tablets on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose A
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose A orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose B
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose B orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose C
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose C orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose D
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose D orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose E
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose E orally on Day 1 post dental extraction.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
3
|
3
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Acetaminophen/Naproxen Sodium Dose Ranging Study
Baseline characteristics by cohort
| Measure |
Placebo
n=53 Participants
Participants who underwent dental extraction of three or four third molars received a single oral dose of two placebo tablets on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose A
n=49 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose A orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose B
n=53 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose B orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose C
n=52 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose C orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose D
n=51 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose D orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose E
n=46 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose E orally on Day 1 post dental extraction.
|
Total
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
18.5 Years
STANDARD_DEVIATION 1.78 • n=99 Participants
|
18.4 Years
STANDARD_DEVIATION 1.83 • n=107 Participants
|
18.6 Years
STANDARD_DEVIATION 2.05 • n=206 Participants
|
18.7 Years
STANDARD_DEVIATION 1.95 • n=7 Participants
|
18.5 Years
STANDARD_DEVIATION 1.82 • n=31 Participants
|
18.2 Years
STANDARD_DEVIATION 1.50 • n=30 Participants
|
18.5 Years
STANDARD_DEVIATION 1.83 • n=3 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
27 Participants
n=31 Participants
|
24 Participants
n=30 Participants
|
154 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
22 Participants
n=30 Participants
|
150 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
36 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
50 Participants
n=7 Participants
|
49 Participants
n=31 Participants
|
37 Participants
n=30 Participants
|
267 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
50 Participants
n=31 Participants
|
45 Participants
n=30 Participants
|
292 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Baseline (0 hour) up to 12 hours post-dose on Day 1Population: Intent-to-Treat (ITT) analysis set included all randomized participants.
Time weighted sum of the pain intensity difference (SPID) score is derived from pain intensity difference (PID) score. Pain intensity-numerical rating scale (PI-NRS) was used to assess pain intensity on scale ranged from 0 (no pain) to 10 (very severe pain), higher score indicated severe pain intensity. PID score was the difference between baseline pain intensity and pain intensity at assessment timepoint (12 hours). The SPID scores were derived by first multiplying each PID score by the time from the previous time point and adding these time weighted PID scores together over the interval from 0 to 12 hours. The possible range of SPID for 0 to 12 hours was from -120 to 120. A higher value of SPID indicated greater pain relief.
Outcome measures
| Measure |
Placebo
n=53 Participants
Participants who underwent dental extraction of three or four third molars received a single oral dose of two placebo tablets on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose A
n=49 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose A orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose B
n=53 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose B orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose C
n=52 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose C orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose D
n=51 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose D orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose E
n=46 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose E orally on Day 1 post dental extraction.
|
|---|---|---|---|---|---|---|
|
Time Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12)
|
5.59 Units on a scale
Standard Deviation 3.741
|
37.08 Units on a scale
Standard Deviation 3.892
|
46.98 Units on a scale
Standard Deviation 3.740
|
52.45 Units on a scale
Standard Deviation 3.779
|
59.63 Units on a scale
Standard Deviation 3.813
|
65.52 Units on a scale
Standard Deviation 4.027
|
SECONDARY outcome
Timeframe: Baseline (0 hour) up to 12 hours post-dose on Day 1Population: ITT analysis set included all randomized participants.
Time weighted total pain relief (TOTPAR) was measured using a Pain Relief Numerical Rating Scale (PR-NRS) ranging from 0 to10 (0 = no relief, 10 = complete relief). A higher score indicated greater pain relief. Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value was 0, and the maximum value was 120. Higher scores were indicative of more pain relief.
Outcome measures
| Measure |
Placebo
n=53 Participants
Participants who underwent dental extraction of three or four third molars received a single oral dose of two placebo tablets on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose A
n=49 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose A orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose B
n=53 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose B orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose C
n=52 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose C orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose D
n=51 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose D orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose E
n=46 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose E orally on Day 1 post dental extraction.
|
|---|---|---|---|---|---|---|
|
Time Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 12 Hours (TOTPAR 0-12)
|
18.40 Units on a scale
Standard Deviation 4.550
|
54.06 Units on a scale
Standard Deviation 4.734
|
67.45 Units on a scale
Standard Deviation 4.548
|
72.04 Units on a scale
Standard Deviation 4.597
|
79.33 Units on a scale
Standard Deviation 4.637
|
85.98 Units on a scale
Standard Deviation 4.898
|
SECONDARY outcome
Timeframe: From 6 hours up to 12 hours post-dose on Day 1Population: ITT analysis set included all randomized participants.
Time weighted sum of the pain intensity difference (SPID) score is derived from PID score. PI-NRS was used to assess pain intensity on scale ranged from 0 (no pain) to 10 (very severe pain), higher score indicated severe pain intensity. PID was the difference between pain intensity at 6 hours and pain intensity at assessment timepoint (12 hours). The SPID scores were derived by first multiplying each PID score by the time from the previous time point and adding these time weighted PID scores together over the intervals from 6 to 12 hours (6 hours). The possible range of SPID for 6 to12 hours was from -60 to 60. A higher value of SPID indicated greater pain relief.
Outcome measures
| Measure |
Placebo
n=53 Participants
Participants who underwent dental extraction of three or four third molars received a single oral dose of two placebo tablets on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose A
n=49 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose A orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose B
n=53 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose B orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose C
n=52 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose C orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose D
n=51 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose D orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose E
n=46 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose E orally on Day 1 post dental extraction.
|
|---|---|---|---|---|---|---|
|
Time Weighted Sum of Pain Intensity Difference Score From 6 Hours to 12 Hours (SPID 6-12)
|
2.58 Units on a scale
Standard Deviation 2.154
|
15.12 Units on a scale
Standard Deviation 2.241
|
20.31 Units on a scale
Standard Deviation 2.153
|
24.47 Units on a scale
Standard Deviation 2.176
|
27.59 Units on a scale
Standard Deviation 2.195
|
31.89 Units on a scale
Standard Deviation 2.318
|
SECONDARY outcome
Timeframe: From 0 minute up to 1440 minutes post-dose (that is, up to 24 hours post-dose) on Day 1Population: ITT analysis set included all randomized participants.
Time to first use of rescue analgesic medication was measured as the elapsed time (in minutes) from when the investigational product was given until the time rescue analgesic was first given. Participants who did not use rescue medication during the 24 hour study period had their time to rescue set to 24 hours and were censored at 24 hours. Kaplan-Meier method was used for the analysis.
Outcome measures
| Measure |
Placebo
n=53 Participants
Participants who underwent dental extraction of three or four third molars received a single oral dose of two placebo tablets on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose A
n=49 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose A orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose B
n=53 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose B orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose C
n=52 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose C orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose D
n=51 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose D orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose E
n=46 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose E orally on Day 1 post dental extraction.
|
|---|---|---|---|---|---|---|
|
Time to First Use of Rescue Analgesic Medication
|
90.0 Minutes
Interval 38.0 to 1440.0
|
898.0 Minutes
Interval 33.0 to 1440.0
|
1195.0 Minutes
Interval 30.0 to 1440.0
|
NA Minutes
Interval 0.0 to 1440.0
Median was not estimable because fewer than 50% of participants required rescue medication.
|
NA Minutes
Interval 68.0 to 1440.0
Median was not estimable because fewer than 50% of participants required rescue medication.
|
NA Minutes
Interval 497.0 to 1440.0
Median was not estimable because fewer than 50% of participants required rescue medication.
|
SECONDARY outcome
Timeframe: From 0 hour up to 24 hours post-dose on Day 1Population: ITT analysis set included all randomized participants.
Proportion (cumulative data) of participants who used rescue analgesic medication through 24 hours post study drug administration on Day 1 which was assessed by using Kaplan-Meier estimates were reported.
Outcome measures
| Measure |
Placebo
n=53 Participants
Participants who underwent dental extraction of three or four third molars received a single oral dose of two placebo tablets on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose A
n=49 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose A orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose B
n=53 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose B orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose C
n=52 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose C orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose D
n=51 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose D orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose E
n=46 Participants
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose E orally on Day 1 post dental extraction.
|
|---|---|---|---|---|---|---|
|
Proportion of Participants Who Required Rescue Analgesic Medication
|
0.792 Proportion of participants
Interval 0.675 to 0.889
|
0.571 Proportion of participants
Interval 0.439 to 0.711
|
0.519 Proportion of participants
Interval 0.392 to 0.659
|
0.353 Proportion of participants
Interval 0.239 to 0.5
|
0.353 Proportion of participants
Interval 0.239 to 0.5
|
0.152 Proportion of participants
Interval 0.076 to 0.293
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Acetaminophen/Naproxen Sodium Dose A
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Acetaminophen/Naproxen Sodium Dose B
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Acetaminophen/Naproxen Sodium Dose C
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Acetaminophen/Naproxen Sodium Dose D
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Acetaminophen/Naproxen Sodium Dose E
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=53 participants at risk
Participants who underwent dental extraction of three or four third molars received a single oral dose of two placebo tablets on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose A
n=49 participants at risk
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose A orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose B
n=53 participants at risk
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose B orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose C
n=52 participants at risk
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose C orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose D
n=51 participants at risk
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose D orally on Day 1 post dental extraction.
|
Acetaminophen/Naproxen Sodium Dose E
n=46 participants at risk
Participants who underwent dental extraction of three or four third molars received two tablets of fixed combination of acetaminophen and naproxen sodium Dose E orally on Day 1 post dental extraction.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
17.0%
9/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
10.2%
5/49 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
3.8%
2/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
3.8%
2/52 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
3.9%
2/51 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
2.2%
1/46 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
|
Gastrointestinal disorders
Vomiting
|
11.3%
6/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
2.0%
1/49 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
3.8%
2/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/52 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
2.0%
1/51 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/46 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
|
Nervous system disorders
Headache
|
1.9%
1/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
2.0%
1/49 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
1.9%
1/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/52 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/51 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
4.3%
2/46 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
2.0%
1/49 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/52 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
2.0%
1/51 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/46 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
|
Infections and infestations
Alveolar osteitis
|
0.00%
0/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/49 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
1.9%
1/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/52 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/51 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/46 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/49 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/52 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
2.0%
1/51 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/46 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/49 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
1.9%
1/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/52 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/51 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/46 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/49 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
1.9%
1/52 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/51 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/46 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.9%
1/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/49 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/52 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/51 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/46 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/49 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/52 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
2.0%
1/51 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/46 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/49 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
1.9%
1/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/52 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/51 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/46 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.9%
1/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/49 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/52 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/51 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/46 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
2.0%
1/49 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
1.9%
1/52 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/51 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/46 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/49 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/53 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
1.9%
1/52 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/51 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
0.00%
0/46 • From baseline (Day 1; day of surgery) up to Day 10
The safety analysis set included all participants who were randomized and took investigational product. Analyzed based on the actual received treatment.
|
Additional Information
Assoc Dir Med Sci Leader US Self Care Pain
Johnson & Johnson Consumer, Inc.
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of study results by the Investigator is discussed in the Clinical Study Agreement, as appropriate. Results from this study may be published in the form of oral or written presentations at scientific meetings or as one or more peer-reviewed journal articles. In these cases, no information on individual subjects will be revealed.
- Publication restrictions are in place
Restriction type: OTHER