Trial Outcomes & Findings for Efficacy and Safety Study of a Test Naproxen Sodium 220mg Tablet in Postoperative Dental Pain (NCT NCT03566979)
NCT ID: NCT03566979
Last Updated: 2020-04-09
Results Overview
Minutes until confirmed first perceptible pain relief was achieved. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The first perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
501 participants
Primary outcome timeframe
12 hours
Results posted on
2020-04-09
Participant Flow
Participant milestones
| Measure |
Placebo
Single dose of two Placebo tablets.
|
Test Naproxen Sodium 440 Milligram (mg)
Single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX).
|
Commercial Naproxen Sodium Tablet 440 mg
Single dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets.
|
Commercial Naproxen Sodium Liquid Gel Capsule 440 mg
Single dose of 440 mg of naproxen sodium administered as two 220 mg commercial liquid gels capsules.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
58
|
152
|
142
|
149
|
|
Overall Study
COMPLETED
|
53
|
145
|
132
|
143
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
10
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Single dose of two Placebo tablets.
|
Test Naproxen Sodium 440 Milligram (mg)
Single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX).
|
Commercial Naproxen Sodium Tablet 440 mg
Single dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets.
|
Commercial Naproxen Sodium Liquid Gel Capsule 440 mg
Single dose of 440 mg of naproxen sodium administered as two 220 mg commercial liquid gels capsules.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
7
|
9
|
5
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety Study of a Test Naproxen Sodium 220mg Tablet in Postoperative Dental Pain
Baseline characteristics by cohort
| Measure |
Placebo
n=58 Participants
Single dose of two Placebo tablets.
|
Test Naproxen Sodium 440 Milligram (mg)
n=152 Participants
Single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX).
|
Commercial Naproxen Sodium Tablet 440 mg
n=142 Participants
Single dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets.
|
Commercial Naproxen Sodium Liquid Gel Capsule 440 mg
n=149 Participants
Single dose of 440 mg of naproxen sodium administered as two 220 mg commercial liquid gels capsules.
|
Total
n=501 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
19.1 years
STANDARD_DEVIATION 2.11 • n=5 Participants
|
18.9 years
STANDARD_DEVIATION 2.2 • n=7 Participants
|
18.9 years
STANDARD_DEVIATION 2.34 • n=5 Participants
|
19.1 years
STANDARD_DEVIATION 2.3 • n=4 Participants
|
19 years
STANDARD_DEVIATION 2.26 • n=21 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
262 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
239 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
129 Participants
n=4 Participants
|
428 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
451 Participants
n=21 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
58 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
149 Participants
n=4 Participants
|
501 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 hoursPopulation: Population analyzed included all randomized participants.
Minutes until confirmed first perceptible pain relief was achieved. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The first perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief.
Outcome measures
| Measure |
Placebo
n=58 Participants
Single dose of two Placebo tablets.
|
Test Naproxen Sodium Tablet (440 mg)
n=152 Participants
Single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX).
|
Commercial Naproxen Sodium Tablets (440 mg)
n=142 Participants
Single dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets.
|
Commercial Naproxen Sodium Liquid Gel Capsules (440 mg)
n=149 Participants
Single dose of 440 mg of naproxen sodium administered as two 220 mg commercial liquid gels capsules.
|
|---|---|---|---|---|
|
Time to Confirmed Perceptible Pain Relief
|
NA Minutes
Interval 3.0 to 720.0
Here NA signifies that median is not estimable as less than 50% of the participants obtained confirmed perceptible pain relief by 12 hours.
|
18.7 Minutes
Interval 2.0 to 720.0
|
23.5 Minutes
Interval 2.5 to 720.0
|
28.1 Minutes
Interval 2.1 to 720.0
|
SECONDARY outcome
Timeframe: Up to 45 minutes after dosingPopulation: Population analyzed included all randomized participants. Data for this outcome measure was planned to be analyzed and reported only for Placebo and Test NPX (440 mg) arms.
Percentage of participants with confirmed perceptible pain relief from 45 minutes to successively earlier minutes in one-minute increments were reported.
Outcome measures
| Measure |
Placebo
n=58 Participants
Single dose of two Placebo tablets.
|
Test Naproxen Sodium Tablet (440 mg)
n=152 Participants
Single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX).
|
Commercial Naproxen Sodium Tablets (440 mg)
Single dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets.
|
Commercial Naproxen Sodium Liquid Gel Capsules (440 mg)
Single dose of 440 mg of naproxen sodium administered as two 220 mg commercial liquid gels capsules.
|
|---|---|---|---|---|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
45 minutes after dosing
|
27.6 Percentage of Participants
|
84.9 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
44 minutes after dosing
|
25.9 Percentage of Participants
|
84.9 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
43 minutes after dosing
|
25.9 Percentage of Participants
|
84.2 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
42 minutes after dosing
|
25.9 Percentage of Participants
|
84.2 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
41 minutes after dosing
|
25.9 Percentage of Participants
|
84.2 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
40 minutes after dosing
|
25.9 Percentage of Participants
|
84.2 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
39 minutes after dosing
|
25.9 Percentage of Participants
|
84.2 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
38 minutes after dosing
|
25.9 Percentage of Participants
|
84.2 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
37 minutes after dosing
|
24.1 Percentage of Participants
|
84.2 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
36 minutes after dosing
|
24.1 Percentage of Participants
|
84.2 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
35 minutes after dosing
|
24.1 Percentage of Participants
|
83.6 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
34 minutes after dosing
|
24.1 Percentage of Participants
|
82.9 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
33 minutes after dosing
|
24.1 Percentage of Participants
|
82.2 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
32 minutes after dosing
|
22.4 Percentage of Participants
|
81.6 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
31 minutes after dosing
|
20.7 Percentage of Participants
|
80.3 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
30 minutes after dosing
|
20.7 Percentage of Participants
|
74.3 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
29 minutes after dosing
|
19.0 Percentage of Participants
|
71.7 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
28 minutes after dosing
|
19.0 Percentage of Participants
|
69.1 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
27 minutes after dosing
|
19.0 Percentage of Participants
|
69.1 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
26 minutes after dosing
|
19.0 Percentage of Participants
|
67.8 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
25 minutes after dosing
|
17.2 Percentage of Participants
|
67.8 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
24 minutes after dosing
|
17.2 Percentage of Participants
|
65.8 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
23 minutes after dosing
|
17.2 Percentage of Participants
|
63.2 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
22 minutes after dosing
|
17.2 Percentage of Participants
|
61.8 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
21 minutes after dosing
|
17.2 Percentage of Participants
|
57.9 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
20 minutes after dosing
|
17.2 Percentage of Participants
|
53.9 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
19 minutes after dosing
|
17.2 Percentage of Participants
|
50.7 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
18 minutes after dosing
|
17.2 Percentage of Participants
|
47.4 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
17 minutes after dosing
|
17.2 Percentage of Participants
|
45.4 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
16 minutes after dosing
|
12.1 Percentage of Participants
|
42.1 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
15 minutes after dosing
|
12.1 Percentage of Participants
|
32.2 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
14 minutes after dosing
|
8.6 Percentage of Participants
|
23.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
13 minutes after dosing
|
8.6 Percentage of Participants
|
17.1 Percentage of Participants
|
—
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Test Naproxen Sodium 440 Milligram (mg)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Commercial Naproxen Sodium Tablet 440 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Commercial Naproxen Sodium Liquid Gel Capsule 440 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=58 participants at risk
Single dose of two Placebo tablets.
|
Test Naproxen Sodium 440 Milligram (mg)
n=152 participants at risk
Single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX).
|
Commercial Naproxen Sodium Tablet 440 mg
n=142 participants at risk
Single dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets.
|
Commercial Naproxen Sodium Liquid Gel Capsule 440 mg
n=149 participants at risk
Single dose of 440 mg of naproxen sodium administered as two 220 mg commercial liquid gels capsules.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
10.3%
6/58 • Up to Day 70
The safety analysis dataset included all participants who took at least one dose of study medication and had any follow-up information.
|
0.00%
0/152 • Up to Day 70
The safety analysis dataset included all participants who took at least one dose of study medication and had any follow-up information.
|
3.5%
5/142 • Up to Day 70
The safety analysis dataset included all participants who took at least one dose of study medication and had any follow-up information.
|
1.3%
2/149 • Up to Day 70
The safety analysis dataset included all participants who took at least one dose of study medication and had any follow-up information.
|
|
Gastrointestinal disorders
Vomiting
|
5.2%
3/58 • Up to Day 70
The safety analysis dataset included all participants who took at least one dose of study medication and had any follow-up information.
|
1.3%
2/152 • Up to Day 70
The safety analysis dataset included all participants who took at least one dose of study medication and had any follow-up information.
|
1.4%
2/142 • Up to Day 70
The safety analysis dataset included all participants who took at least one dose of study medication and had any follow-up information.
|
2.0%
3/149 • Up to Day 70
The safety analysis dataset included all participants who took at least one dose of study medication and had any follow-up information.
|
Additional Information
Steven Sacavage, Associate Director Clinical Research
Johnson & Johnson Worldwide
Phone: 215-273-8568
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER