Trial Outcomes & Findings for Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study (NCT NCT03879408)
NCT ID: NCT03879408
Last Updated: 2022-12-05
Results Overview
Time-weighted sum of the pain intensity difference (SPID) score was measured using a Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-6 hours was from -60 to 60. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment. Time-weighted sum of the pain intensity difference 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 0 to 6 hours.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
290 participants
Primary outcome timeframe
Baseline (0 hour) up to 6 hours post-dose
Results posted on
2022-12-05
Participant Flow
Participant milestones
| Measure |
Arm 1: Placebo
Participants received a single oral dose of four placebo tablets at baseline (Day of surgery-Day 1).
|
Arm 2: Naproxen Sodium 440 mg
Participants received a single oral dose of naproxen sodium 440 milligrams (mg)(administered as two naproxen sodium 220 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1).
|
Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg
Participants received a single oral dose of naproxen sodium 220 mg tablet (administered as one naproxen sodium 220 mg tablet) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and one placebo tablet at baseline (Day of surgery-Day 1).
|
Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg
Participants received a single oral dose of naproxen sodium 440 mg (administered as two naproxen sodium 220 mg tablets) and acetaminophen 1000 mg (two acetaminophen 500 mg tablets) at baseline (Day of surgery-Day 1).
|
Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg
Participants received a single oral dose of hydrocodone 10 mg (administered as two hydrocodone 5 mg tablets) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
69
|
61
|
63
|
62
|
|
Overall Study
COMPLETED
|
33
|
65
|
58
|
62
|
61
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
3
|
1
|
1
|
Reasons for withdrawal
| Measure |
Arm 1: Placebo
Participants received a single oral dose of four placebo tablets at baseline (Day of surgery-Day 1).
|
Arm 2: Naproxen Sodium 440 mg
Participants received a single oral dose of naproxen sodium 440 milligrams (mg)(administered as two naproxen sodium 220 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1).
|
Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg
Participants received a single oral dose of naproxen sodium 220 mg tablet (administered as one naproxen sodium 220 mg tablet) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and one placebo tablet at baseline (Day of surgery-Day 1).
|
Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg
Participants received a single oral dose of naproxen sodium 440 mg (administered as two naproxen sodium 220 mg tablets) and acetaminophen 1000 mg (two acetaminophen 500 mg tablets) at baseline (Day of surgery-Day 1).
|
Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg
Participants received a single oral dose of hydrocodone 10 mg (administered as two hydrocodone 5 mg tablets) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1).
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
1
|
0
|
1
|
Baseline Characteristics
Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study
Baseline characteristics by cohort
| Measure |
Arm 1: Placebo
n=35 Participants
Participants received a single oral dose of four placebo tablets at baseline (Day of surgery-Day 1).
|
Arm 2: Naproxen Sodium 440 mg
n=69 Participants
Participants received a single oral dose of naproxen sodium 440 milligrams (mg)(administered as two naproxen sodium 220 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1).
|
Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg
n=61 Participants
Participants received a single oral dose of naproxen sodium 220 mg tablet (administered as one naproxen sodium 220 mg tablet) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and one placebo tablet at baseline (Day of surgery-Day 1).
|
Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg
n=63 Participants
Participants received a single oral dose of naproxen sodium 440 mg (administered as two naproxen sodium 220 mg tablets) and acetaminophen 1000 mg (two acetaminophen 500 mg tablets) at baseline (Day of surgery-Day 1).
|
Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg
n=62 Participants
Participants received a single oral dose of hydrocodone 10 mg (administered as two hydrocodone 5 mg tablets) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1).
|
Total
n=290 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
18.4 years
STANDARD_DEVIATION 1.50 • n=5 Participants
|
19.0 years
STANDARD_DEVIATION 2.39 • n=7 Participants
|
18.2 years
STANDARD_DEVIATION 1.33 • n=5 Participants
|
19.0 years
STANDARD_DEVIATION 2.23 • n=4 Participants
|
18.3 years
STANDARD_DEVIATION 1.70 • n=21 Participants
|
18.6 years
STANDARD_DEVIATION 1.95 • n=8 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
155 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
135 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
34 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
256 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
261 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline (0 hour) up to 6 hours post-dosePopulation: Intent-to-Treat (ITT) analysis set included all randomized participants.
Time-weighted sum of the pain intensity difference (SPID) score was measured using a Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-6 hours was from -60 to 60. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment. Time-weighted sum of the pain intensity difference 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 0 to 6 hours.
Outcome measures
| Measure |
Arm 1: Placebo
n=35 Participants
Participants received a single oral dose of four placebo tablets at baseline (Day of surgery-Day 1).
|
Arm 2: Naproxen Sodium 440 mg
n=69 Participants
Participants received a single oral dose of naproxen sodium 440 milligrams (mg)(administered as two naproxen sodium 220 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1).
|
Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg
n=61 Participants
Participants received a single oral dose of naproxen sodium 220 mg tablet (administered as one naproxen sodium 220 mg tablet) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and one placebo tablet at baseline (Day of surgery-Day 1).
|
Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg
n=63 Participants
Participants received a single oral dose of naproxen sodium 440 mg (administered as two naproxen sodium 220 mg tablets) and acetaminophen 1000 mg (two acetaminophen 500 mg tablets) at baseline (Day of surgery-Day 1).
|
Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg
n=62 Participants
Participants received a single oral dose of hydrocodone 10 mg (administered as two hydrocodone 5 mg tablets) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1).
|
|---|---|---|---|---|---|
|
Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 6 Hours (SPID 0-6)
|
2.36 Units on a scale
Standard Error 2.181
|
25.59 Units on a scale
Standard Error 1.562
|
30.28 Units on a scale
Standard Error 1.677
|
33.77 Units on a scale
Standard Error 1.633
|
23.60 Units on a scale
Standard Error 1.651
|
PRIMARY outcome
Timeframe: Baseline (0 hour) up to 12 hours post-dosePopulation: ITT analysis set included all randomized participants.
Time-weighted sum of the pain intensity difference score was measured using a PI-NRS ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-12 hours was from -120 to 120. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment (12 hours). Time-weighted sum of the pain intensity difference 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 0 to 12 hours.
Outcome measures
| Measure |
Arm 1: Placebo
n=35 Participants
Participants received a single oral dose of four placebo tablets at baseline (Day of surgery-Day 1).
|
Arm 2: Naproxen Sodium 440 mg
n=69 Participants
Participants received a single oral dose of naproxen sodium 440 milligrams (mg)(administered as two naproxen sodium 220 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1).
|
Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg
n=61 Participants
Participants received a single oral dose of naproxen sodium 220 mg tablet (administered as one naproxen sodium 220 mg tablet) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and one placebo tablet at baseline (Day of surgery-Day 1).
|
Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg
n=63 Participants
Participants received a single oral dose of naproxen sodium 440 mg (administered as two naproxen sodium 220 mg tablets) and acetaminophen 1000 mg (two acetaminophen 500 mg tablets) at baseline (Day of surgery-Day 1).
|
Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg
n=62 Participants
Participants received a single oral dose of hydrocodone 10 mg (administered as two hydrocodone 5 mg tablets) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1).
|
|---|---|---|---|---|---|
|
Time-weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12)
|
5.80 Units on a scale
Standard Error 4.666
|
50.07 Units on a scale
Standard Error 3.341
|
55.47 Units on a scale
Standard Error 3.587
|
66.43 Units on a scale
Standard Error 3.494
|
39.94 Units on a scale
Standard Error 3.533
|
SECONDARY outcome
Timeframe: Baseline (0 hour) up to 6 hours post-dosePopulation: 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 0-10 (0 = no relief, 10 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose 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 60. Higher scores was indicative of more pain relief.
Outcome measures
| Measure |
Arm 1: Placebo
n=35 Participants
Participants received a single oral dose of four placebo tablets at baseline (Day of surgery-Day 1).
|
Arm 2: Naproxen Sodium 440 mg
n=69 Participants
Participants received a single oral dose of naproxen sodium 440 milligrams (mg)(administered as two naproxen sodium 220 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1).
|
Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg
n=61 Participants
Participants received a single oral dose of naproxen sodium 220 mg tablet (administered as one naproxen sodium 220 mg tablet) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and one placebo tablet at baseline (Day of surgery-Day 1).
|
Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg
n=63 Participants
Participants received a single oral dose of naproxen sodium 440 mg (administered as two naproxen sodium 220 mg tablets) and acetaminophen 1000 mg (two acetaminophen 500 mg tablets) at baseline (Day of surgery-Day 1).
|
Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg
n=62 Participants
Participants received a single oral dose of hydrocodone 10 mg (administered as two hydrocodone 5 mg tablets) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1).
|
|---|---|---|---|---|---|
|
Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 6 Hours (TOTPAR 0-6)
|
7.96 Units on a scale
Standard Error 2.581
|
35.20 Units on a scale
Standard Error 1.848
|
40.94 Units on a scale
Standard Error 1.984
|
45.13 Units on a scale
Standard Error 1.933
|
32.88 Units on a scale
Standard Error 1.954
|
SECONDARY outcome
Timeframe: Baseline (0 hour) up to 8 hours post-dosePopulation: ITT analysis set included all randomized participants.
TOTPAR was measured using a PR-NRS ranging from 0-10 (0 = no relief, 10 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose 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 80. Higher scores was indicative of more pain relief.
Outcome measures
| Measure |
Arm 1: Placebo
n=35 Participants
Participants received a single oral dose of four placebo tablets at baseline (Day of surgery-Day 1).
|
Arm 2: Naproxen Sodium 440 mg
n=69 Participants
Participants received a single oral dose of naproxen sodium 440 milligrams (mg)(administered as two naproxen sodium 220 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1).
|
Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg
n=61 Participants
Participants received a single oral dose of naproxen sodium 220 mg tablet (administered as one naproxen sodium 220 mg tablet) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and one placebo tablet at baseline (Day of surgery-Day 1).
|
Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg
n=63 Participants
Participants received a single oral dose of naproxen sodium 440 mg (administered as two naproxen sodium 220 mg tablets) and acetaminophen 1000 mg (two acetaminophen 500 mg tablets) at baseline (Day of surgery-Day 1).
|
Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg
n=62 Participants
Participants received a single oral dose of hydrocodone 10 mg (administered as two hydrocodone 5 mg tablets) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1).
|
|---|---|---|---|---|---|
|
Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 8 Hours (TOTPAR 0-8)
|
11.12 Units on a scale
Standard Error 3.554
|
47.19 Units on a scale
Standard Error 2.545
|
54.37 Units on a scale
Standard Error 2.732
|
60.78 Units on a scale
Standard Error 2.662
|
41.61 Units on a scale
Standard Error 2.691
|
SECONDARY outcome
Timeframe: Baseline (0 hour) up to 12 hours post-dosePopulation: ITT analysis set included all randomized participants.
TOTPAR was measured using a PR-NRS ranging from 0-10 (0 = no relief, 10 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose 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 was indicative of more pain relief.
Outcome measures
| Measure |
Arm 1: Placebo
n=35 Participants
Participants received a single oral dose of four placebo tablets at baseline (Day of surgery-Day 1).
|
Arm 2: Naproxen Sodium 440 mg
n=69 Participants
Participants received a single oral dose of naproxen sodium 440 milligrams (mg)(administered as two naproxen sodium 220 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1).
|
Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg
n=61 Participants
Participants received a single oral dose of naproxen sodium 220 mg tablet (administered as one naproxen sodium 220 mg tablet) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and one placebo tablet at baseline (Day of surgery-Day 1).
|
Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg
n=63 Participants
Participants received a single oral dose of naproxen sodium 440 mg (administered as two naproxen sodium 220 mg tablets) and acetaminophen 1000 mg (two acetaminophen 500 mg tablets) at baseline (Day of surgery-Day 1).
|
Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg
n=62 Participants
Participants received a single oral dose of hydrocodone 10 mg (administered as two hydrocodone 5 mg tablets) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1).
|
|---|---|---|---|---|---|
|
Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 12 Hours (TOTPAR 0-12)
|
18.20 Units on a scale
Standard Error 5.595
|
69.96 Units on a scale
Standard Error 4.006
|
76.80 Units on a scale
Standard Error 4.301
|
90.22 Units on a scale
Standard Error 4.190
|
57.03 Units on a scale
Standard Error 4.237
|
SECONDARY outcome
Timeframe: Baseline (0 hour) up to 8 hours post-dosePopulation: ITT analysis set included all randomized participants.
Time-weighted sum of the pain intensity difference score was measured using a PI-NRS ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-8 hours was from -80 to 80. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment (8 hours). Time-weighted sum of the pain intensity difference 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 0 to 8 hours.
Outcome measures
| Measure |
Arm 1: Placebo
n=35 Participants
Participants received a single oral dose of four placebo tablets at baseline (Day of surgery-Day 1).
|
Arm 2: Naproxen Sodium 440 mg
n=69 Participants
Participants received a single oral dose of naproxen sodium 440 milligrams (mg)(administered as two naproxen sodium 220 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1).
|
Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg
n=61 Participants
Participants received a single oral dose of naproxen sodium 220 mg tablet (administered as one naproxen sodium 220 mg tablet) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and one placebo tablet at baseline (Day of surgery-Day 1).
|
Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg
n=63 Participants
Participants received a single oral dose of naproxen sodium 440 mg (administered as two naproxen sodium 220 mg tablets) and acetaminophen 1000 mg (two acetaminophen 500 mg tablets) at baseline (Day of surgery-Day 1).
|
Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg
n=62 Participants
Participants received a single oral dose of hydrocodone 10 mg (administered as two hydrocodone 5 mg tablets) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1).
|
|---|---|---|---|---|---|
|
Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 8 Hours (SPID 0-8)
|
3.24 Units on a scale
Standard Error 2.981
|
34.11 Units on a scale
Standard Error 2.134
|
39.98 Units on a scale
Standard Error 2.291
|
45.27 Units on a scale
Standard Error 2.232
|
29.58 Units on a scale
Standard Error 2.257
|
SECONDARY outcome
Timeframe: 0.25 hours, 0.5 hours, 0.75 hours, 1 hours, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, and 12 hoursPopulation: ITT analysis set included all randomized participants.
Participants answered a question at individual time points: "how much relief do you have from your starting pain?" on a 11-point PR-NRS. Scale ranged from 0=no relief to 10=complete relief. Higher score indicated improvement in pain.
Outcome measures
| Measure |
Arm 1: Placebo
n=35 Participants
Participants received a single oral dose of four placebo tablets at baseline (Day of surgery-Day 1).
|
Arm 2: Naproxen Sodium 440 mg
n=69 Participants
Participants received a single oral dose of naproxen sodium 440 milligrams (mg)(administered as two naproxen sodium 220 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1).
|
Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg
n=61 Participants
Participants received a single oral dose of naproxen sodium 220 mg tablet (administered as one naproxen sodium 220 mg tablet) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and one placebo tablet at baseline (Day of surgery-Day 1).
|
Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg
n=63 Participants
Participants received a single oral dose of naproxen sodium 440 mg (administered as two naproxen sodium 220 mg tablets) and acetaminophen 1000 mg (two acetaminophen 500 mg tablets) at baseline (Day of surgery-Day 1).
|
Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg
n=62 Participants
Participants received a single oral dose of hydrocodone 10 mg (administered as two hydrocodone 5 mg tablets) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1).
|
|---|---|---|---|---|---|
|
Pain Relief (PAR) Scores at Individual Timepoints
0.5 Hours
|
0.51 Units on a scale
Standard Error 0.44
|
2.27 Units on a scale
Standard Error 0.31
|
3.46 Units on a scale
Standard Error 0.33
|
4.03 Units on a scale
Standard Error 0.33
|
3.23 Units on a scale
Standard Error 0.36
|
|
Pain Relief (PAR) Scores at Individual Timepoints
0.75 Hours
|
0.77 Units on a scale
Standard Error 0.48
|
4.11 Units on a scale
Standard Error 0.35
|
5.10 Units on a scale
Standard Error 0.37
|
5.71 Units on a scale
Standard Error 0.36
|
5.08 Units on a scale
Standard Error 0.36
|
|
Pain Relief (PAR) Scores at Individual Timepoints
1 Hours
|
1.06 Units on a scale
Standard Error 0.49
|
5.29 Units on a scale
Standard Error 0.35
|
5.91 Units on a scale
Standard Error 0.38
|
6.60 Units on a scale
Standard Error 0.37
|
6.03 Units on a scale
Standard Error 0.37
|
|
Pain Relief (PAR) Scores at Individual Timepoints
1.25 Hours
|
1.13 Units on a scale
Standard Error 0.49
|
5.99 Units on a scale
Standard Error 0.35
|
6.46 Units on a scale
Standard Error 0.38
|
7.17 Units on a scale
Standard Error 0.37
|
6.40 Units on a scale
Standard Error 0.37
|
|
Pain Relief (PAR) Scores at Individual Timepoints
8 Hours
|
1.65 Units on a scale
Standard Error 0.54
|
5.95 Units on a scale
Standard Error 0.39
|
6.63 Units on a scale
Standard Error 0.42
|
7.71 Units on a scale
Standard Error 0.41
|
4.23 Units on a scale
Standard Error 0.41
|
|
Pain Relief (PAR) Scores at Individual Timepoints
10 Hours
|
1.73 Units on a scale
Standard Error 0.58
|
5.71 Units on a scale
Standard Error 0.42
|
5.66 Units on a scale
Standard Error 0.45
|
7.49 Units on a scale
Standard Error 0.44
|
3.66 Units on a scale
Standard Error 0.44
|
|
Pain Relief (PAR) Scores at Individual Timepoints
12 Hours
|
1.89 Units on a scale
Standard Error 0.61
|
5.62 Units on a scale
Standard Error 0.44
|
5.18 Units on a scale
Standard Error 0.47
|
7.25 Units on a scale
Standard Error 0.46
|
3.98 Units on a scale
Standard Error 0.46
|
|
Pain Relief (PAR) Scores at Individual Timepoints
0.25 hours
|
0.45 Units on a scale
Standard Error 0.26
|
0.80 Units on a scale
Standard Error 0.18
|
1.36 Units on a scale
Standard Error 0.20
|
1.07 Units on a scale
Standard Error 0.19
|
1.04 Units on a scale
Standard Error 0.20
|
|
Pain Relief (PAR) Scores at Individual Timepoints
1.5 Hours
|
1.18 Units on a scale
Standard Error 0.48
|
6.36 Units on a scale
Standard Error 0.34
|
6.89 Units on a scale
Standard Error 0.37
|
7.65 Units on a scale
Standard Error 0.36
|
6.44 Units on a scale
Standard Error 0.36
|
|
Pain Relief (PAR) Scores at Individual Timepoints
2 Hours
|
1.08 Units on a scale
Standard Error 0.48
|
6.62 Units on a scale
Standard Error 0.34
|
7.37 Units on a scale
Standard Error 0.37
|
7.97 Units on a scale
Standard Error 0.36
|
6.38 Units on a scale
Standard Error 0.36
|
|
Pain Relief (PAR) Scores at Individual Timepoints
3 Hours
|
1.37 Units on a scale
Standard Error 0.49
|
6.52 Units on a scale
Standard Error 0.35
|
7.61 Units on a scale
Standard Error 0.38
|
8.24 Units on a scale
Standard Error 0.37
|
6.26 Units on a scale
Standard Error 0.37
|
|
Pain Relief (PAR) Scores at Individual Timepoints
4 Hours
|
1.66 Units on a scale
Standard Error 0.51
|
1.46 Units on a scale
Standard Error 0.36
|
7.68 Units on a scale
Standard Error 0.39
|
8.46 Units on a scale
Standard Error 0.38
|
5.96 Units on a scale
Standard Error 0.38
|
|
Pain Relief (PAR) Scores at Individual Timepoints
5 Hours
|
1.59 Units on a scale
Standard Error 0.52
|
6.45 Units on a scale
Standard Error 0.37
|
7.43 Units on a scale
Standard Error 0.40
|
8.23 Units on a scale
Standard Error 0.39
|
5.54 Units on a scale
Standard Error 0.40
|
|
Pain Relief (PAR) Scores at Individual Timepoints
6 Hours
|
1.53 Units on a scale
Standard Error 0.53
|
6.26 Units on a scale
Standard Error 0.38
|
7.23 Units on a scale
Standard Error 0.41
|
8.15 Units on a scale
Standard Error 0.40
|
4.88 Units on a scale
Standard Error 0.40
|
|
Pain Relief (PAR) Scores at Individual Timepoints
7 Hours
|
1.51 Units on a scale
Standard Error 0.55
|
6.05 Units on a scale
Standard Error 0.39
|
6.80 Units on a scale
Standard Error 0.42
|
7.94 Units on a scale
Standard Error 0.41
|
4.50 Units on a scale
Standard Error 0.41
|
|
Pain Relief (PAR) Scores at Individual Timepoints
9 Hours
|
1.61 Units on a scale
Standard Error 0.56
|
5.73 Units on a scale
Standard Error 0.40
|
6.27 Units on a scale
Standard Error 0.43
|
7.44 Units on a scale
Standard Error 0.42
|
3.88 Units on a scale
Standard Error 0.43
|
|
Pain Relief (PAR) Scores at Individual Timepoints
11 Hours
|
1.86 Units on a scale
Standard Error 0.60
|
5.71 Units on a scale
Standard Error 0.43
|
5.33 Units on a scale
Standard Error 0.46
|
7.26 Units on a scale
Standard Error 0.45
|
3.91 Units on a scale
Standard Error 0.46
|
SECONDARY outcome
Timeframe: 0.25 hours, 0.5 hours, 0.75 hours, 1 hours, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, and 12 hoursPopulation: ITT analysis set included all randomized participants.
Pain Intensity was self-reported over 12 hours, using a pain rating of 0-10 on the PI-NRS, with score ranged from 0-10 (0= no pain; 10 = worst imaginable pain). Pain intensity differences were calculated with respect to baseline at each time point after study drug administration.
Outcome measures
| Measure |
Arm 1: Placebo
n=35 Participants
Participants received a single oral dose of four placebo tablets at baseline (Day of surgery-Day 1).
|
Arm 2: Naproxen Sodium 440 mg
n=69 Participants
Participants received a single oral dose of naproxen sodium 440 milligrams (mg)(administered as two naproxen sodium 220 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1).
|
Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg
n=61 Participants
Participants received a single oral dose of naproxen sodium 220 mg tablet (administered as one naproxen sodium 220 mg tablet) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and one placebo tablet at baseline (Day of surgery-Day 1).
|
Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg
n=63 Participants
Participants received a single oral dose of naproxen sodium 440 mg (administered as two naproxen sodium 220 mg tablets) and acetaminophen 1000 mg (two acetaminophen 500 mg tablets) at baseline (Day of surgery-Day 1).
|
Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg
n=62 Participants
Participants received a single oral dose of hydrocodone 10 mg (administered as two hydrocodone 5 mg tablets) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1).
|
|---|---|---|---|---|---|
|
Pain Intensity Difference (PID) Scores at Individual Time Points
0.25 hours
|
0.25 Units on a scale
Standard Error 0.21
|
0.58 Units on a scale
Standard Error 0.15
|
1.01 Units on a scale
Standard Error 0.16
|
0.85 Units on a scale
Standard Error 0.15
|
00.79 Units on a scale
Standard Error 0.16
|
|
Pain Intensity Difference (PID) Scores at Individual Time Points
0.5 Hours
|
0.07 Units on a scale
Standard Error 0.33
|
1.82 Units on a scale
Standard Error 0.24
|
2.61 Units on a scale
Standard Error 0.25
|
3.06 Units on a scale
Standard Error 0.25
|
2.36 Units on a scale
Standard Error 0.25
|
|
Pain Intensity Difference (PID) Scores at Individual Time Points
1.5 Hours
|
0.31 Units on a scale
Standard Error 0.39
|
4.72 Units on a scale
Standard Error 0.28
|
5.18 Units on a scale
Standard Error 0.30
|
5.76 Units on a scale
Standard Error 0.29
|
4.74 Units on a scale
Standard Error 0.30
|
|
Pain Intensity Difference (PID) Scores at Individual Time Points
2 Hours
|
0.22 Units on a scale
Standard Error 0.40
|
4.87 Units on a scale
Standard Error 0.28
|
5.49 Units on a scale
Standard Error 0.31
|
6.01 Units on a scale
Standard Error 0.30
|
4.67 Units on a scale
Standard Error 0.30
|
|
Pain Intensity Difference (PID) Scores at Individual Time Points
11 Hours
|
0.69 Units on a scale
Standard Error 0.50
|
3.99 Units on a scale
Standard Error 0.35
|
3.63 Units on a scale
Standard Error 0.38
|
5.16 Units on a scale
Standard Error 0.37
|
2.71 Units on a scale
Standard Error 0.37
|
|
Pain Intensity Difference (PID) Scores at Individual Time Points
0.75 Hours
|
0.24 Units on a scale
Standard Error 0.38
|
3.15 Units on a scale
Standard Error 0.27
|
3.82 Units on a scale
Standard Error 0.29
|
4.31 Units on a scale
Standard Error 0.29
|
3.77 Units on a scale
Standard Error 0.29
|
|
Pain Intensity Difference (PID) Scores at Individual Time Points
1 Hours
|
0.45 Units on a scale
Standard Error 0.39
|
3.97 Units on a scale
Standard Error 0.28
|
4.41 Units on a scale
Standard Error 0.30
|
4.95 Units on a scale
Standard Error 0.29
|
4.48 Units on a scale
Standard Error 0.30
|
|
Pain Intensity Difference (PID) Scores at Individual Time Points
1.25 Hours
|
0.34 Units on a scale
Standard Error 0.40
|
4.50 Units on a scale
Standard Error 0.28
|
4.87 Units on a scale
Standard Error 0.30
|
5.42 Units on a scale
Standard Error 0.30
|
4.71 Units on a scale
Standard Error 0.30
|
|
Pain Intensity Difference (PID) Scores at Individual Time Points
3 Hours
|
0.34 Units on a scale
Standard Error 0.41
|
4.75 Units on a scale
Standard Error 0.30
|
5.62 Units on a scale
Standard Error 0.32
|
6.17 Units on a scale
Standard Error 0.31
|
4.51 Units on a scale
Standard Error 0.31
|
|
Pain Intensity Difference (PID) Scores at Individual Time Points
4 Hours
|
0.53 Units on a scale
Standard Error 0.43
|
4.63 Units on a scale
Standard Error 0.31
|
5.64 Units on a scale
Standard Error 0.33
|
6.31 Units on a scale
Standard Error 0.32
|
4.26 Units on a scale
Standard Error 0.33
|
|
Pain Intensity Difference (PID) Scores at Individual Time Points
5 Hours
|
0.50 Units on a scale
Standard Error 0.44
|
4.59 Units on a scale
Standard Error 0.32
|
5.51 Units on a scale
Standard Error 0.34
|
6.13 Units on a scale
Standard Error 0.33
|
3.89 Units on a scale
Standard Error 0.34
|
|
Pain Intensity Difference (PID) Scores at Individual Time Points
6 Hours
|
0.47 Units on a scale
Standard Error 0.44
|
4.50 Units on a scale
Standard Error 0.32
|
5.28 Units on a scale
Standard Error 0.34
|
6.06 Units on a scale
Standard Error 0.33
|
3.39 Units on a scale
Standard Error 0.34
|
|
Pain Intensity Difference (PID) Scores at Individual Time Points
7 Hours
|
0.40 Units on a scale
Standard Error 0.45
|
4.36 Units on a scale
Standard Error 0.32
|
4.96 Units on a scale
Standard Error 0.34
|
5.82 Units on a scale
Standard Error 0.34
|
3.08 Units on a scale
Standard Error 0.34
|
|
Pain Intensity Difference (PID) Scores at Individual Time Points
8 Hours
|
0.48 Units on a scale
Standard Error 0.45
|
4.17 Units on a scale
Standard Error 0.32
|
4.74 Units on a scale
Standard Error 0.34
|
5.68 Units on a scale
Standard Error 0.34
|
2.90 Units on a scale
Standard Error 0.34
|
|
Pain Intensity Difference (PID) Scores at Individual Time Points
9 Hours
|
0.53 Units on a scale
Standard Error 0.46
|
4.04 Units on a scale
Standard Error 0.33
|
4.46 Units on a scale
Standard Error 0.35
|
5.41 Units on a scale
Standard Error 0.34
|
2.56 Units on a scale
Standard Error 0.35
|
|
Pain Intensity Difference (PID) Scores at Individual Time Points
10 Hours
|
0.64 Units on a scale
Standard Error 0.40
|
4.01 Units on a scale
Standard Error 0.35
|
3.87 Units on a scale
Standard Error 0.37
|
5.43 Units on a scale
Standard Error 0.36
|
2.42 Units on a scale
Standard Error 0.37
|
|
Pain Intensity Difference (PID) Scores at Individual Time Points
12 Hours
|
0.71 Units on a scale
Standard Error 0.50
|
3.91 Units on a scale
Standard Error 0.36
|
3.53 Units on a scale
Standard Error 0.38
|
5.16 Units on a scale
Standard Error 0.37
|
2.66 Units on a scale
Standard Error 0.38
|
SECONDARY outcome
Timeframe: Up to 12 hoursPopulation: ITT analysis set included all randomized participants. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Participants were asked to rate their overall impression of the study medication using the following scale: poor (0), fair (1), good (2), very good (3), and excellent (4) where higher score represented better outcome.
Outcome measures
| Measure |
Arm 1: Placebo
n=35 Participants
Participants received a single oral dose of four placebo tablets at baseline (Day of surgery-Day 1).
|
Arm 2: Naproxen Sodium 440 mg
n=69 Participants
Participants received a single oral dose of naproxen sodium 440 milligrams (mg)(administered as two naproxen sodium 220 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1).
|
Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg
n=60 Participants
Participants received a single oral dose of naproxen sodium 220 mg tablet (administered as one naproxen sodium 220 mg tablet) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and one placebo tablet at baseline (Day of surgery-Day 1).
|
Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg
n=63 Participants
Participants received a single oral dose of naproxen sodium 440 mg (administered as two naproxen sodium 220 mg tablets) and acetaminophen 1000 mg (two acetaminophen 500 mg tablets) at baseline (Day of surgery-Day 1).
|
Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg
n=61 Participants
Participants received a single oral dose of hydrocodone 10 mg (administered as two hydrocodone 5 mg tablets) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1).
|
|---|---|---|---|---|---|
|
Participant's Global Evaluation of Study Medication OR Overall Impression of Study Medication According to Participant's Global Evaluation
|
0.8 Units on a Scale
Standard Error 0.18
|
2.7 Units on a Scale
Standard Error 0.13
|
2.9 Units on a Scale
Standard Error 0.14
|
3.3 Units on a Scale
Standard Error 0.13
|
2.7 Units on a Scale
Standard Error 0.14
|
Adverse Events
Arm 1: Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Arm 2: Naproxen Sodium 440 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1: Placebo
n=35 participants at risk
Participants received a single oral dose of four placebo tablets at baseline (Day of surgery-Day 1).
|
Arm 2: Naproxen Sodium 440 mg
n=69 participants at risk
Participants received a single oral dose of naproxen sodium 440 milligrams (mg)(administered as two naproxen sodium 220 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1).
|
Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg
n=61 participants at risk
Participants received a single oral dose of naproxen sodium 220 mg tablet (administered as one naproxen sodium 220 mg tablet) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and one placebo tablet at baseline (Day of surgery-Day 1).
|
Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg
n=63 participants at risk
Participants received a single oral dose of naproxen sodium 440 mg (administered as two naproxen sodium 220 mg tablets) and acetaminophen 1000 mg (two acetaminophen 500 mg tablets) at baseline (Day of surgery-Day 1).
|
Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg
n=62 participants at risk
Participants received a single oral dose of hydrocodone 10 mg (administered as two hydrocodone 5 mg tablets) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1).
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
25.7%
9/35 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
2.9%
2/69 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
3.3%
2/61 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
4.8%
3/63 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
32.3%
20/62 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
7/35 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
2.9%
2/69 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
6.6%
4/61 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
9.5%
6/63 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
14.5%
9/62 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
1/35 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
0.00%
0/69 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
0.00%
0/61 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
0.00%
0/63 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
0.00%
0/62 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.9%
1/35 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
0.00%
0/69 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
0.00%
0/61 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
0.00%
0/63 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
0.00%
0/62 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
|
Infections and infestations
Alveolar osteitis
|
0.00%
0/35 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
1.4%
1/69 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
4.9%
3/61 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
1.6%
1/63 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
0.00%
0/62 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.9%
1/35 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
0.00%
0/69 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
3.3%
2/61 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
1.6%
1/63 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
0.00%
0/62 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/35 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
0.00%
0/69 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
0.00%
0/61 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
1.6%
1/63 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
1.6%
1/62 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
|
Infections and infestations
Influenza
|
0.00%
0/35 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
1.4%
1/69 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
0.00%
0/61 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
0.00%
0/63 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
0.00%
0/62 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/35 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
2.9%
2/69 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
1.6%
1/61 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
1.6%
1/63 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
4.8%
3/62 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
|
Nervous system disorders
Headache
|
11.4%
4/35 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
0.00%
0/69 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
0.00%
0/61 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
0.00%
0/63 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
1.6%
1/62 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
|
Investigations
Blood urine present
|
0.00%
0/35 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
1.4%
1/69 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
0.00%
0/61 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
0.00%
0/63 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
0.00%
0/62 • Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
|
Additional Information
ASSOCIATE DIRECTOR CLINICAL RESEARCH
Johnson & Johnson Consumer, Inc.
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Draft abstracts, manuscripts, and materials for presentation at scientific meetings must be sent to the sponsor at least 60 working days prior to abstract or other relevant submission deadlines. Authorship of publications resulting from this study was based on generally accepted criteria for major medical journals.
- Publication restrictions are in place
Restriction type: OTHER