Trial Outcomes & Findings for Evaluate Efficacy and Safety of Extended Release (ER) Naproxen Sodium (NCT NCT01389284)
NCT ID: NCT01389284
Last Updated: 2015-08-25
Results Overview
SPID0-24 was calculated by multiplying the pain intensity difference score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over 0 to 24 hours. Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. SPID0-24 can vary from -24 to 72. The positive SPID value indicates improvement of pain relief. The higher the SPID value, the more improvement of pain relief.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
300 participants
Primary outcome timeframe
From 0 to 24 hours post-dose
Results posted on
2015-08-25
Participant Flow
Participant milestones
| Measure |
Naproxen Sodium ER (BAYH6689)
1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
|
Naproxen Sodium IR (Aleve, BAYH6689)
1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
|
Placebo
1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
|
|---|---|---|---|
|
Overall Study
STARTED
|
120
|
120
|
60
|
|
Overall Study
COMPLETED
|
120
|
120
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate Efficacy and Safety of Extended Release (ER) Naproxen Sodium
Baseline characteristics by cohort
| Measure |
Naproxen Sodium ER (BAYH6689)
n=120 Participants
1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
|
Naproxen Sodium IR (Aleve, BAYH6689)
n=120 Participants
1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
|
Placebo
n=60 Participants
1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
24.0 Years
STANDARD_DEVIATION 5.05 • n=5 Participants
|
23.0 Years
STANDARD_DEVIATION 4.67 • n=7 Participants
|
25.0 Years
STANDARD_DEVIATION 6.56 • n=5 Participants
|
23.8 Years
STANDARD_DEVIATION 5.28 • n=4 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
182 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
|
Pain Intensity Score
0 = None
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Pain Intensity Score
1 = Mild
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Pain Intensity Score
2 = Moderate
|
96 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
246 Participants
n=4 Participants
|
|
Pain Intensity Score
3 = Severe
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From 0 to 24 hours post-dosePopulation: Intent-to-treat (ITT)
SPID0-24 was calculated by multiplying the pain intensity difference score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over 0 to 24 hours. Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. SPID0-24 can vary from -24 to 72. The positive SPID value indicates improvement of pain relief. The higher the SPID value, the more improvement of pain relief.
Outcome measures
| Measure |
Naproxen Sodium ER (BAYH6689)
n=120 Participants
1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
|
Naproxen Sodium IR (Aleve, BAYH6689)
n=120 Participants
1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
|
Placebo
n=60 Participants
1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
|
|---|---|---|---|
|
Summed, Time-weighted Pain Intensity Difference From 0 to 24 Hours Postdose (SPID0-24)
|
23.2 Score on the scale
Standard Error 2.01
|
23.6 Score on the scale
Standard Error 2.01
|
-0.6 Score on the scale
Standard Error 2.85
|
SECONDARY outcome
Timeframe: 0-6, 0-8, 0-12, 0-16 and 16-24 hours postdosePopulation: Intent-to-treat (ITT)
Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total possible score ranges of SPIDs are SPID0-6: -6 to 18, SPID0-8: -8 to 24, SPID0-12: -12 to 36, SPID0-16: -16 to 48, SPID16-24: -8 to 24. The positive SPID value indicates improvement of pain relief. The higher the SPID value, the more improvement of pain relief.
Outcome measures
| Measure |
Naproxen Sodium ER (BAYH6689)
n=120 Participants
1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
|
Naproxen Sodium IR (Aleve, BAYH6689)
n=120 Participants
1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
|
Placebo
n=60 Participants
1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
|
|---|---|---|---|
|
Summed, Time-weighted Pain Intensity Differences (SPID)
From 0 to 6 hours, LS Mean
|
5.3 Score on the scale
Interval 4.5 to 6.7
|
5.3 Score on the scale
Interval 4.5 to 6.1
|
-0.5 Score on the scale
Interval -1.6 to 0.7
|
|
Summed, Time-weighted Pain Intensity Differences (SPID)
From 0 to 8 hours, LS Mean
|
7.0 Score on the scale
Interval 5.9 to 8.1
|
6.9 Score on the scale
Interval 5.7 to 8.0
|
-0.8 Score on the scale
Interval -2.3 to 0.8
|
|
Summed, Time-weighted Pain Intensity Differences (SPID)
From 0 to 12 hours, LS Mean
|
10.9 Score on the scale
Interval 9.1 to 12.7
|
10.9 Score on the scale
Interval 9.2 to 12.7
|
-0.9 Score on the scale
Interval -3.4 to 1.6
|
|
Summed, Time-weighted Pain Intensity Differences (SPID)
From 0 to 16 hours, LS Mean
|
14.7 Score on the scale
Interval 12.3 to 17.2
|
15.0 Score on the scale
Interval 12.5 to 17.5
|
-1.0 Score on the scale
Interval -4.5 to 2.6
|
|
Summed, Time-weighted Pain Intensity Differences (SPID)
From 16 to 24 hours, LS Mean
|
8.5 Score on the scale
Interval 6.9 to 10.0
|
8.6 Score on the scale
Interval 7.1 to 10.1
|
0.4 Score on the scale
Interval -1.8 to 2.6
|
SECONDARY outcome
Timeframe: 0-6, 0-8, 0-12, 0-16, 0-24, and 16-24 hours postdosePopulation: Intent-to-treat (ITT)
TOTPARs were derived by multiplying the pain relief score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over the specified interval. Pain Relief was evaluated at 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours postdose, using the 5-point overall pain relief scale: 0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief. The possible total score ranges of TOTPARs are: TOTPAR0-6: 0 to 18, TOTPAR0-8: 0 to 24, TOTPAR0-12: 0 to 36, TOTPAR0-16: 0 to 48, TOTPAR0-24: 0 to 72, TOTPAR16-24: 0 to 24.
Outcome measures
| Measure |
Naproxen Sodium ER (BAYH6689)
n=120 Participants
1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
|
Naproxen Sodium IR (Aleve, BAYH6689)
n=120 Participants
1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
|
Placebo
n=60 Participants
1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
|
|---|---|---|---|
|
Summed, Time-weighted Total Pain Relief Scores (TOTPARs)
From 0 to 6 hours
|
13.1 Score on the scale
Interval 11.9 to 14.3
|
12.8 Score on the scale
Interval 11.6 to 14.0
|
4.7 Score on the scale
Interval 2.9 to 6.4
|
|
Summed, Time-weighted Total Pain Relief Scores (TOTPARs)
From 0 to 8 hours
|
17.4 Score on the scale
Interval 15.7 to 19.1
|
16.8 Score on the scale
Interval 15.1 to 18.5
|
6.1 Score on the scale
Interval 3.8 to 8.5
|
|
Summed, Time-weighted Total Pain Relief Scores (TOTPARs)
From 0 to 12 hours
|
26.5 Score on the scale
Interval 23.9 to 29.2
|
26.4 Score on the scale
Interval 23.7 to 29.0
|
9.7 Score on the scale
Interval 5.9 to 13.5
|
|
Summed, Time-weighted Total Pain Relief Scores (TOTPARs)
From 0 to 16 hours
|
35.5 Score on the scale
Interval 31.8 to 39.2
|
35.8 Score on the scale
Interval 32.0 to 39.5
|
13.4 Score on the scale
Interval 8.1 to 18.6
|
|
Summed, Time-weighted Total Pain Relief Scores (TOTPARs)
From 0 to 24 hours
|
54.5 Score on the scale
Interval 48.6 to 60.4
|
55.1 Score on the scale
Interval 49.2 to 61.0
|
21.8 Score on the scale
Interval 13.4 to 30.2
|
|
Summed, Time-weighted Total Pain Relief Scores (TOTPARs)
From 16 to 24 hours
|
19.0 Score on the scale
Interval 16.7 to 21.3
|
19.4 Score on the scale
Interval 17.1 to 21.6
|
8.4 Score on the scale
Interval 5.2 to 11.6
|
SECONDARY outcome
Timeframe: At 0, 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdosePopulation: Intent-to-treat (ITT)
Pain intensity was evaluated using a 4-point Categorical Pain Intensity Rating Scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe
Outcome measures
| Measure |
Naproxen Sodium ER (BAYH6689)
n=120 Participants
1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
|
Naproxen Sodium IR (Aleve, BAYH6689)
n=120 Participants
1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
|
Placebo
n=60 Participants
1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
|
|---|---|---|---|
|
Pain Intensity Differences (PIDs) by Time From Initial Dose
0.25 hours, LS Mean
|
1.9 Score on the scale
Interval 1.8 to 2.0
|
2.0 Score on the scale
Interval 1.9 to 2.1
|
2.0 Score on the scale
Interval 1.9 to 2.2
|
|
Pain Intensity Differences (PIDs) by Time From Initial Dose
0.5 hours, LS Mean
|
1.7 Score on the scale
Interval 1.6 to 1.8
|
1.7 Score on the scale
Interval 1.6 to 1.8
|
1.9 Score on the scale
Interval 1.8 to 2.1
|
|
Pain Intensity Differences (PIDs) by Time From Initial Dose
0.75 hours, LS Mean
|
1.4 Score on the scale
Interval 1.3 to 1.6
|
1.5 Score on the scale
Interval 1.4 to 1.6
|
2.0 Score on the scale
Interval 1.8 to 2.2
|
|
Pain Intensity Differences (PIDs) by Time From Initial Dose
1 hours, LS Mean
|
1.2 Score on the scale
Interval 1.1 to 1.4
|
1.4 Score on the scale
Interval 1.3 to 1.5
|
2.1 Score on the scale
Interval 1.9 to 2.3
|
|
Pain Intensity Differences (PIDs) by Time From Initial Dose
2 hours, LS Mean
|
1.2 Score on the scale
Interval 1.1 to 1.4
|
1.2 Score on the scale
Interval 1.0 to 1.3
|
2.3 Score on the scale
Interval 2.1 to 2.5
|
|
Pain Intensity Differences (PIDs) by Time From Initial Dose
3 hours, LS Mean
|
1.2 Score on the scale
Interval 1.1 to 1.4
|
1.2 Score on the scale
Interval 1.0 to 1.3
|
2.3 Score on the scale
Interval 2.1 to 2.6
|
|
Pain Intensity Differences (PIDs) by Time From Initial Dose
4 hours, LS Mean
|
1.2 Score on the scale
Interval 1.0 to 1.3
|
1.2 Score on the scale
Interval 1.1 to 1.4
|
2.3 Score on the scale
Interval 2.1 to 2.5
|
|
Pain Intensity Differences (PIDs) by Time From Initial Dose
5 hours, LS Mean
|
1.3 Score on the scale
Interval 1.1 to 1.4
|
1.2 Score on the scale
Interval 1.1 to 1.4
|
2.3 Score on the scale
Interval 2.1 to 2.5
|
|
Pain Intensity Differences (PIDs) by Time From Initial Dose
6 hours, LS Mean
|
1.3 Score on the scale
Interval 1.1 to 1.4
|
1.3 Score on the scale
Interval 1.1 to 1.4
|
2.3 Score on the scale
Interval 2.1 to 2.5
|
|
Pain Intensity Differences (PIDs) by Time From Initial Dose
8 hours, LS Mean
|
1.3 Score on the scale
Interval 1.2 to 1.5
|
1.4 Score on the scale
Interval 1.2 to 1.6
|
2.3 Score on the scale
Interval 2.1 to 2.6
|
|
Pain Intensity Differences (PIDs) by Time From Initial Dose
12 hours, LS Mean
|
1.2 Score on the scale
Interval 1.0 to 1.4
|
1.2 Score on the scale
Interval 1.0 to 1.3
|
2.2 Score on the scale
Interval 2.0 to 2.5
|
|
Pain Intensity Differences (PIDs) by Time From Initial Dose
16 hours, LS Mean
|
1.2 Score on the scale
Interval 1.0 to 1.4
|
1.2 Score on the scale
Interval 1.0 to 1.4
|
2.2 Score on the scale
Interval 1.9 to 2.5
|
|
Pain Intensity Differences (PIDs) by Time From Initial Dose
20 hours, LS Mean
|
1.2 Score on the scale
Interval 1.0 to 1.4
|
1.1 Score on the scale
Interval 1.0 to 1.3
|
2.2 Score on the scale
Interval 1.9 to 2.5
|
|
Pain Intensity Differences (PIDs) by Time From Initial Dose
24 hours, LS Mean
|
1.1 Score on the scale
Interval 0.9 to 1.3
|
1.1 Score on the scale
Interval 0.9 to 1.3
|
2.1 Score on the scale
Interval 1.8 to 2.3
|
SECONDARY outcome
Timeframe: At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdosePopulation: Intent-to-treat (ITT)
Pain Relief was evaluated using the 5-point overall pain relief scale: 0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief
Outcome measures
| Measure |
Naproxen Sodium ER (BAYH6689)
n=120 Participants
1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
|
Naproxen Sodium IR (Aleve, BAYH6689)
n=120 Participants
1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
|
Placebo
n=60 Participants
1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
|
|---|---|---|---|
|
Pain Relief From Initial Dose
0.25 hours
|
0.9 Score on the scale
Standard Deviation 0.96
|
0.8 Score on the scale
Standard Deviation 0.92
|
0.6 Score on the scale
Standard Deviation 0.75
|
|
Pain Relief From Initial Dose
0.5 hours
|
1.5 Score on the scale
Standard Deviation 1.08
|
1.3 Score on the scale
Standard Deviation 1.02
|
0.8 Score on the scale
Standard Deviation 0.94
|
|
Pain Relief From Initial Dose
0.75 hours
|
2.0 Score on the scale
Standard Deviation 1.21
|
1.7 Score on the scale
Standard Deviation 1.14
|
0.9 Score on the scale
Standard Deviation 0.96
|
|
Pain Relief From Initial Dose
1 hour
|
2.2 Score on the scale
Standard Deviation 1.29
|
2.0 Score on the scale
Standard Deviation 1.17
|
0.9 Score on the scale
Standard Deviation 1.02
|
|
Pain Relief From Initial Dose
2 hours
|
2.3 Score on the scale
Standard Deviation 1.30
|
2.3 Score on the scale
Standard Deviation 1.29
|
0.8 Score on the scale
Standard Deviation 1.02
|
|
Pain Relief From Initial Dose
3 hours
|
2.3 Score on the scale
Standard Deviation 1.33
|
2.4 Score on the scale
Standard Deviation 1.39
|
0.7 Score on the scale
Standard Deviation 1.03
|
|
Pain Relief From Initial Dose
4 hours
|
2.4 Score on the scale
Standard Deviation 1.41
|
2.2 Score on the scale
Standard Deviation 1.43
|
0.9 Score on the scale
Standard Deviation 1.20
|
|
Pain Relief From Initial Dose
5 hours
|
2.3 Score on the scale
Standard Deviation 1.35
|
2.2 Score on the scale
Standard Deviation 1.49
|
0.9 Score on the scale
Standard Deviation 1.23
|
|
Pain Relief From Initial Dose
6 hours
|
2.2 Score on the scale
Standard Deviation 1.37
|
2.2 Score on the scale
Standard Deviation 1.53
|
0.8 Score on the scale
Standard Deviation 1.28
|
|
Pain Relief From Initial Dose
8 hours
|
2.1 Score on the scale
Standard Deviation 1.40
|
2.0 Score on the scale
Standard Deviation 1.50
|
0.8 Score on the scale
Standard Deviation 1.23
|
|
Pain Relief From Initial Dose
12 hours
|
2.3 Score on the scale
Standard Deviation 1.51
|
2.4 Score on the scale
Standard Deviation 1.57
|
0.9 Score on the scale
Standard Deviation 1.46
|
|
Pain Relief From Initial Dose
16 hours
|
2.2 Score on the scale
Standard Deviation 1.52
|
2.3 Score on the scale
Standard Deviation 1.61
|
1.0 Score on the scale
Standard Deviation 1.47
|
|
Pain Relief From Initial Dose
20 hours
|
2.3 Score on the scale
Standard Deviation 1.58
|
2.3 Score on the scale
Standard Deviation 1.63
|
1.0 Score on the scale
Standard Deviation 1.50
|
|
Pain Relief From Initial Dose
24 hours
|
2.4 Score on the scale
Standard Deviation 1.63
|
2.5 Score on the scale
Standard Deviation 1.68
|
1.2 Score on the scale
Standard Deviation 1.73
|
SECONDARY outcome
Timeframe: Up to 24 hours postdosePopulation: Intent-to-treat (ITT)
Time to first use of rescue medication was estimated using Kaplan-Meier method and analyzed by a logrank test stratified by baseline pain intensity. If at least 50% of subjects in a treatment group took rescue medication, the median time to first rescue was determined for that treatment group.
Outcome measures
| Measure |
Naproxen Sodium ER (BAYH6689)
n=120 Participants
1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
|
Naproxen Sodium IR (Aleve, BAYH6689)
n=120 Participants
1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
|
Placebo
n=60 Participants
1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
|
|---|---|---|---|
|
Median Time to First Intake of Rescue Medication
|
NA Hours
Median Time to Rescue Medication was not computable because less than 50% of the participants did take rescue medication.
|
NA Hours
Median Time to Rescue Medication was not computable because less than 50% of the participants did take rescue medication.
|
2.9 Hours
Interval 1.0 to 12.0
|
SECONDARY outcome
Timeframe: At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdosePopulation: Intent-to-treat (ITT)
Outcome measures
| Measure |
Naproxen Sodium ER (BAYH6689)
n=120 Participants
1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
|
Naproxen Sodium IR (Aleve, BAYH6689)
n=120 Participants
1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
|
Placebo
n=60 Participants
1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
|
|---|---|---|---|
|
Cumulative Percentage of Participants Who Took Rescue Medication
0.25 hours
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Cumulative Percentage of Participants Who Took Rescue Medication
0.5 hours
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Cumulative Percentage of Participants Who Took Rescue Medication
0.75 hours
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Cumulative Percentage of Participants Who Took Rescue Medication
1 hour
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Cumulative Percentage of Participants Who Took Rescue Medication
2 hours
|
7.5 Percentage of participants
|
7.5 Percentage of participants
|
30.0 Percentage of participants
|
|
Cumulative Percentage of Participants Who Took Rescue Medication
3 hours
|
12.5 Percentage of participants
|
13.3 Percentage of participants
|
50.0 Percentage of participants
|
|
Cumulative Percentage of Participants Who Took Rescue Medication
4 hours
|
16.7 Percentage of participants
|
16.7 Percentage of participants
|
55.0 Percentage of participants
|
|
Cumulative Percentage of Participants Who Took Rescue Medication
5 hours
|
18.3 Percentage of participants
|
20.0 Percentage of participants
|
58.3 Percentage of participants
|
|
Cumulative Percentage of Participants Who Took Rescue Medication
6 hours
|
20.0 Percentage of participants
|
23.3 Percentage of participants
|
60.0 Percentage of participants
|
|
Cumulative Percentage of Participants Who Took Rescue Medication
8 hours
|
20.8 Percentage of participants
|
25.0 Percentage of participants
|
63.3 Percentage of participants
|
|
Cumulative Percentage of Participants Who Took Rescue Medication
12 hours
|
22.5 Percentage of participants
|
25.8 Percentage of participants
|
66.7 Percentage of participants
|
|
Cumulative Percentage of Participants Who Took Rescue Medication
16 hours
|
25.0 Percentage of participants
|
27.5 Percentage of participants
|
66.7 Percentage of participants
|
|
Cumulative Percentage of Participants Who Took Rescue Medication
20 hours
|
26.7 Percentage of participants
|
27.5 Percentage of participants
|
66.7 Percentage of participants
|
|
Cumulative Percentage of Participants Who Took Rescue Medication
24 hours
|
26.7 Percentage of participants
|
27.5 Percentage of participants
|
66.7 Percentage of participants
|
SECONDARY outcome
Timeframe: 24 hours postdosePopulation: Intent-to-treat (ITT)
Outcome measures
| Measure |
Naproxen Sodium ER (BAYH6689)
n=120 Participants
1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
|
Naproxen Sodium IR (Aleve, BAYH6689)
n=120 Participants
1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
|
Placebo
n=60 Participants
1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
|
|---|---|---|---|
|
Number of Times the Participants Took Rescue Medication Over the 24-hour Period
|
0.5 Rescue medication intakes
Standard Deviation 0.86
|
0.6 Rescue medication intakes
Standard Deviation 1.02
|
1.4 Rescue medication intakes
Standard Deviation 1.20
|
SECONDARY outcome
Timeframe: 24 hours postdose or immediately before the first intake of rescue medicationPopulation: Intent-to-treat (ITT)
Global assessment of investigational product as a pain reliever was rated on a 5-point categorical scale: 0 = poor, 1 = fair, 2 = good, 3 = very good, 4 = excellent
Outcome measures
| Measure |
Naproxen Sodium ER (BAYH6689)
n=120 Participants
1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
|
Naproxen Sodium IR (Aleve, BAYH6689)
n=120 Participants
1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
|
Placebo
n=60 Participants
1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
|
|---|---|---|---|
|
Global Assessment of the Investigational Product as a Pain Reliever
0 - Poor
|
16 Participants
|
18 Participants
|
34 Participants
|
|
Global Assessment of the Investigational Product as a Pain Reliever
1 - Fair
|
14 Participants
|
12 Participants
|
5 Participants
|
|
Global Assessment of the Investigational Product as a Pain Reliever
2 - Good
|
22 Participants
|
20 Participants
|
5 Participants
|
|
Global Assessment of the Investigational Product as a Pain Reliever
3 - Very good
|
33 Participants
|
43 Participants
|
12 Participants
|
|
Global Assessment of the Investigational Product as a Pain Reliever
4 - Excellent
|
35 Participants
|
27 Participants
|
4 Participants
|
Adverse Events
Naproxen Sodium ER (BAYH6689)
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Naproxen Sodium IR (Aleve, BAYH6689)
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Naproxen Sodium ER (BAYH6689)
n=120 participants at risk
1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
|
Naproxen Sodium IR (Aleve, BAYH6689)
n=120 participants at risk
1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
|
Placebo
n=60 participants at risk
1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
|
|---|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.83%
1/120 • Number of events 1
|
1.7%
2/120 • Number of events 2
|
0.00%
0/60
|
|
Gastrointestinal disorders
Abdominal pain
|
0.83%
1/120 • Number of events 1
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/120
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Gastrointestinal disorders
Nausea
|
8.3%
10/120 • Number of events 10
|
7.5%
9/120 • Number of events 9
|
13.3%
8/60 • Number of events 8
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
4/120 • Number of events 4
|
2.5%
3/120 • Number of events 3
|
3.3%
2/60 • Number of events 2
|
|
Gastrointestinal disorders
Dental discomfort
|
0.83%
1/120 • Number of events 1
|
0.00%
0/120
|
0.00%
0/60
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/120
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/120
|
0.00%
0/120
|
1.7%
1/60 • Number of events 1
|
|
General disorders
Feeling hot
|
0.00%
0/120
|
1.7%
2/120 • Number of events 2
|
0.00%
0/60
|
|
General disorders
Pain
|
0.00%
0/120
|
0.00%
0/120
|
1.7%
1/60 • Number of events 1
|
|
General disorders
Tenderness
|
0.83%
1/120 • Number of events 1
|
0.00%
0/120
|
0.00%
0/60
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/120
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Infections and infestations
Tooth infection
|
0.00%
0/120
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.83%
1/120 • Number of events 1
|
0.00%
0/120
|
0.00%
0/60
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/120
|
0.00%
0/120
|
1.7%
1/60 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/120
|
0.00%
0/120
|
1.7%
1/60 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
1.7%
2/120 • Number of events 3
|
5.0%
6/120 • Number of events 6
|
3.3%
2/60 • Number of events 3
|
|
Nervous system disorders
Headache
|
9.2%
11/120 • Number of events 11
|
11.7%
14/120 • Number of events 14
|
20.0%
12/60 • Number of events 12
|
|
Nervous system disorders
Hypoaesthesia
|
1.7%
2/120 • Number of events 2
|
3.3%
4/120 • Number of events 4
|
5.0%
3/60 • Number of events 3
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/120
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Nervous system disorders
Syncope
|
0.83%
1/120 • Number of events 1
|
0.00%
0/120
|
0.00%
0/60
|
|
Psychiatric disorders
Anxiety
|
0.83%
1/120 • Number of events 1
|
0.00%
0/120
|
0.00%
0/60
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/120
|
0.00%
0/120
|
1.7%
1/60 • Number of events 1
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/120
|
0.00%
0/120
|
1.7%
1/60 • Number of events 1
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.83%
1/120 • Number of events 1
|
0.00%
0/120
|
0.00%
0/60
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis
|
0.83%
1/120 • Number of events 1
|
2.5%
3/120 • Number of events 3
|
3.3%
2/60 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.83%
1/120 • Number of events 1
|
0.00%
0/120
|
0.00%
0/60
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/120
|
0.00%
0/120
|
1.7%
1/60 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.83%
1/120 • Number of events 1
|
0.83%
1/120 • Number of events 1
|
3.3%
2/60 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/120
|
0.00%
0/120
|
1.7%
1/60 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.83%
1/120 • Number of events 1
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/120
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place