Trial Outcomes & Findings for A Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain (NCT NCT03404206)
NCT ID: NCT03404206
Last Updated: 2019-07-18
Results Overview
Time to first use of rescue medication was estimated using Kaplan-Meier method. If a subject did not take the rescue medication during the treatment period, (s)he was censored at the time of last assessment.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
387 participants
Primary outcome timeframe
Up to 24 hours
Results posted on
2019-07-18
Participant Flow
The study was conducted at one center in the United States, between 12 February 2018 (first patient first visit) and 10 July 2018 (last patient last visit).
Overall, 387 participants completed surgical teeth extraction, and all of them were randomized and received the treatment.
Participant milestones
| Measure |
Naproxen Sodium (Aleve, BAY117031)
Participants received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization
|
Ibuprofen (Advil)
Participants received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization
|
Placebo
Participants received one single dose of matching placebo tablets (2 tablets, oral) after randomization
|
|---|---|---|---|
|
Overall Study
STARTED
|
166
|
166
|
55
|
|
Overall Study
COMPLETED
|
162
|
164
|
55
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
0
|
Reasons for withdrawal
| Measure |
Naproxen Sodium (Aleve, BAY117031)
Participants received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization
|
Ibuprofen (Advil)
Participants received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization
|
Placebo
Participants received one single dose of matching placebo tablets (2 tablets, oral) after randomization
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
0
|
Baseline Characteristics
A Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain
Baseline characteristics by cohort
| Measure |
Naproxen Sodium (Aleve, BAY117031)
n=166 Participants
Participants received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization
|
Ibuprofen (Advil)
n=166 Participants
Participants received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization
|
Placebo
n=55 Participants
Participants received one single dose of matching placebo tablets (2 tablets, oral) after randomization
|
Total
n=387 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
19.0 years
STANDARD_DEVIATION 2.96 • n=5 Participants
|
19.0 years
STANDARD_DEVIATION 2.62 • n=7 Participants
|
19.0 years
STANDARD_DEVIATION 2.91 • n=5 Participants
|
19.0 years
STANDARD_DEVIATION 2.80 • n=4 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
196 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
191 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
143 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
329 Participants
n=4 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
|
|
Race/Ethnicity, Customized
White
|
148 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
344 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Pain Intensity Score
No Pain (0)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Pain Intensity Score
Mild Pain (1)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Pain Intensity Score
Moderate Pain (2)
|
69 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
159 Participants
n=4 Participants
|
|
Pain Intensity Score
Severe Pain (3)
|
97 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
228 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 24 hoursPopulation: Per-protocol population
Time to first use of rescue medication was estimated using Kaplan-Meier method. If a subject did not take the rescue medication during the treatment period, (s)he was censored at the time of last assessment.
Outcome measures
| Measure |
Naproxen Sodium (Aleve, BAY117031)
n=166 Participants
Participants received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization
|
Ibuprofen (Advil)
n=165 Participants
Participants received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization
|
Placebo
n=54 Participants
Participants received one single dose of matching placebo tablets (2 tablets, oral) after randomization
|
|---|---|---|---|
|
Time to First Use of Rescue Medication
Minimum
|
1.22 hours
|
1.22 hours
|
1.18 hours
|
|
Time to First Use of Rescue Medication
25th Percentile
|
11.017 hours
|
8.267 hours
|
2.117 hours
|
|
Time to First Use of Rescue Medication
50th Percentile
|
NA hours
Not estimable due to censored data
|
10.533 hours
|
2.533 hours
|
|
Time to First Use of Rescue Medication
75th Percentile
|
NA hours
Not estimable due to censored data
|
14.117 hours
|
12.100 hours
|
|
Time to First Use of Rescue Medication
Maximum
|
22.17 hours
|
18.28 hours
|
21.75 hours
|
SECONDARY outcome
Timeframe: Up to 24 hoursPopulation: Per-protocol population
Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted sum of pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.
Outcome measures
| Measure |
Naproxen Sodium (Aleve, BAY117031)
n=166 Participants
Participants received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization
|
Ibuprofen (Advil)
n=165 Participants
Participants received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization
|
Placebo
n=54 Participants
Participants received one single dose of matching placebo tablets (2 tablets, oral) after randomization
|
|---|---|---|---|
|
Sum of Pain Intensity Difference (SPID)
|
83.29 Scores on a scale * hours
Standard Deviation 57.177
|
48.54 Scores on a scale * hours
Standard Deviation 40.705
|
9.96 Scores on a scale * hours
Standard Deviation 58.197
|
SECONDARY outcome
Timeframe: Up to 24 hoursPopulation: Per-protocol population
Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief 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.
Outcome measures
| Measure |
Naproxen Sodium (Aleve, BAY117031)
n=166 Participants
Participants received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization
|
Ibuprofen (Advil)
n=165 Participants
Participants received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization
|
Placebo
n=54 Participants
Participants received one single dose of matching placebo tablets (2 tablets, oral) after randomization
|
|---|---|---|---|
|
Total Pain Relief (TOTPAR)
|
47.16 Scores on a scale * hours
Standard Deviation 28.228
|
28.96 Scores on a scale * hours
Standard Deviation 21.097
|
13.40 Scores on a scale * hours
Standard Deviation 23.328
|
Adverse Events
Naproxen Sodium (Aleve, BAY117031)
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Ibuprofen (Advil)
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Naproxen Sodium (Aleve, BAY117031)
n=166 participants at risk
Subjects received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization
|
Placebo
n=55 participants at risk
Subjects received one single dose of matching placebo tablets (2 tablets, oral) after randomization
|
Ibuprofen (Advil)
n=166 participants at risk
Subjects received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization
|
|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.60%
1/166 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/55 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/166 • From start of study drug up to 10 days after the administration of study drug
|
Other adverse events
| Measure |
Naproxen Sodium (Aleve, BAY117031)
n=166 participants at risk
Subjects received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization
|
Placebo
n=55 participants at risk
Subjects received one single dose of matching placebo tablets (2 tablets, oral) after randomization
|
Ibuprofen (Advil)
n=166 participants at risk
Subjects received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.4%
9/166 • Number of events 10 • From start of study drug up to 10 days after the administration of study drug
|
20.0%
11/55 • Number of events 12 • From start of study drug up to 10 days after the administration of study drug
|
10.2%
17/166 • Number of events 20 • From start of study drug up to 10 days after the administration of study drug
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.60%
1/166 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/55 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/166 • From start of study drug up to 10 days after the administration of study drug
|
|
Gastrointestinal disorders
Vomiting
|
0.60%
1/166 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
12.7%
7/55 • Number of events 10 • From start of study drug up to 10 days after the administration of study drug
|
4.2%
7/166 • Number of events 9 • From start of study drug up to 10 days after the administration of study drug
|
|
General disorders
Pyrexia
|
0.00%
0/166 • From start of study drug up to 10 days after the administration of study drug
|
1.8%
1/55 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
0.60%
1/166 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/166 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/55 • From start of study drug up to 10 days after the administration of study drug
|
0.60%
1/166 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
|
Infections and infestations
Alveolar osteitis
|
2.4%
4/166 • Number of events 4 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/55 • From start of study drug up to 10 days after the administration of study drug
|
0.60%
1/166 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
|
Infections and infestations
Ear infection
|
0.00%
0/166 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/55 • From start of study drug up to 10 days after the administration of study drug
|
0.60%
1/166 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
|
Infections and infestations
Periodontitis
|
0.60%
1/166 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/55 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/166 • From start of study drug up to 10 days after the administration of study drug
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/166 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/55 • From start of study drug up to 10 days after the administration of study drug
|
0.60%
1/166 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
|
Infections and infestations
Upper respiratory tract infection
|
0.60%
1/166 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/55 • From start of study drug up to 10 days after the administration of study drug
|
0.60%
1/166 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.60%
1/166 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/55 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/166 • From start of study drug up to 10 days after the administration of study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/166 • From start of study drug up to 10 days after the administration of study drug
|
1.8%
1/55 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/166 • From start of study drug up to 10 days after the administration of study drug
|
|
Nervous system disorders
Dizziness
|
2.4%
4/166 • Number of events 5 • From start of study drug up to 10 days after the administration of study drug
|
1.8%
1/55 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
3.0%
5/166 • Number of events 5 • From start of study drug up to 10 days after the administration of study drug
|
|
Nervous system disorders
Headache
|
1.8%
3/166 • Number of events 3 • From start of study drug up to 10 days after the administration of study drug
|
12.7%
7/55 • Number of events 7 • From start of study drug up to 10 days after the administration of study drug
|
3.6%
6/166 • Number of events 6 • From start of study drug up to 10 days after the administration of study drug
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/166 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/55 • From start of study drug up to 10 days after the administration of study drug
|
0.60%
1/166 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
|
Nervous system disorders
Tremor
|
0.00%
0/166 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/55 • From start of study drug up to 10 days after the administration of study drug
|
0.60%
1/166 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/166 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/55 • From start of study drug up to 10 days after the administration of study drug
|
0.60%
1/166 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
|
Eye disorders
Eye pain
|
0.60%
1/166 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/55 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/166 • From start of study drug up to 10 days after the administration of study drug
|
|
Eye disorders
Eye swelling
|
0.00%
0/166 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/55 • From start of study drug up to 10 days after the administration of study drug
|
0.60%
1/166 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
0.60%
1/166 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/55 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/166 • From start of study drug up to 10 days after the administration of study drug
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/166 • From start of study drug up to 10 days after the administration of study drug
|
1.8%
1/55 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/166 • From start of study drug up to 10 days after the administration of study drug
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.60%
1/166 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/55 • From start of study drug up to 10 days after the administration of study drug
|
0.60%
1/166 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
|
Gastrointestinal disorders
Breath odour
|
0.60%
1/166 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/55 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/166 • From start of study drug up to 10 days after the administration of study drug
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/166 • From start of study drug up to 10 days after the administration of study drug
|
1.8%
1/55 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/166 • From start of study drug up to 10 days after the administration of study drug
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/166 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/55 • From start of study drug up to 10 days after the administration of study drug
|
0.60%
1/166 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.60%
1/166 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/55 • From start of study drug up to 10 days after the administration of study drug
|
0.60%
1/166 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.2%
2/166 • Number of events 2 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/55 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/166 • From start of study drug up to 10 days after the administration of study drug
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/166 • From start of study drug up to 10 days after the administration of study drug
|
0.00%
0/55 • From start of study drug up to 10 days after the administration of study drug
|
0.60%
1/166 • Number of events 1 • From start of study drug up to 10 days after the administration of study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place