Trial Outcomes & Findings for Efficacy of 300 mg Ibuprofen Prolonged-Release Tablets for the Treatment of Pain After Surgical Removal of Impacted Third Molars (NCT NCT03785756)
NCT ID: NCT03785756
Last Updated: 2024-06-03
Results Overview
SPID12 was used to compare the test product (2 × 300 mg ibuprofen PR tablets) and comparator product (2 × 200 mg ibuprofen IR tablets three times a day \[TID\]) against the placebo product. An 11-point (0-10) numeric rating scale (NRS) for pain was used to assess pain intensity, where a higher score indicates a greater amount of pain. SPID12 was calculated using the summed pain intensity difference (change from Time 0) under the NRS-time curve from 15 minutes through 12 hours calculated using the linear trapezoidal rule and the actual time points, where Time 0 is the time of the first dose of study drug. The minimum value of SPID12 is 0 (no change in pain intensity from Time 0 to 12 hours); the theoretical maximum is 120 (if a patient had a score of 10 \[worst pain intensity\] at baseline, which decreased to 0 \[no pain\] at the next time point and remained at 0 after); a higher SPID12 score indicates a better outcome.
COMPLETED
PHASE3
280 participants
0-12 hours
2024-06-03
Participant Flow
Participant milestones
| Measure |
Prolonged Release Group
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Immediate Release Group
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
|---|---|---|---|
|
Overall Study
STARTED
|
120
|
120
|
40
|
|
Overall Study
COMPLETED
|
111
|
112
|
35
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of 300 mg Ibuprofen Prolonged-Release Tablets for the Treatment of Pain After Surgical Removal of Impacted Third Molars
Baseline characteristics by cohort
| Measure |
Prolonged Release Group
n=120 Participants
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Immediate Release Group
n=120 Participants
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
n=39 Participants
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Total
n=279 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
19.6 years
STANDARD_DEVIATION 2.02 • n=5 Participants
|
19.8 years
STANDARD_DEVIATION 2.47 • n=7 Participants
|
20.7 years
STANDARD_DEVIATION 3.13 • n=5 Participants
|
19.8 years
STANDARD_DEVIATION 2.42 • n=4 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
149 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
130 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
101 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
236 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
107 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
251 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Baseline Pain
|
7.5 units on a scale
STANDARD_DEVIATION 1.23 • n=5 Participants
|
7.6 units on a scale
STANDARD_DEVIATION 1.17 • n=7 Participants
|
7.8 units on a scale
STANDARD_DEVIATION 1.12 • n=5 Participants
|
7.6 units on a scale
STANDARD_DEVIATION 1.19 • n=4 Participants
|
|
Baseline Pain Category
Moderate
|
63 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
|
Baseline Pain Category
Severe
|
57 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
144 Participants
n=4 Participants
|
|
Height
|
168.72 cm
STANDARD_DEVIATION 9.753 • n=5 Participants
|
171.61 cm
STANDARD_DEVIATION 8.517 • n=7 Participants
|
167.85 cm
STANDARD_DEVIATION 6.223 • n=5 Participants
|
169.84 cm
STANDARD_DEVIATION 8.917 • n=4 Participants
|
|
Weight
|
67.99 kg
STANDARD_DEVIATION 13.931 • n=5 Participants
|
73.17 kg
STANDARD_DEVIATION 13.921 • n=7 Participants
|
69.69 kg
STANDARD_DEVIATION 12.041 • n=5 Participants
|
70.46 kg
STANDARD_DEVIATION 13.847 • n=4 Participants
|
|
BMI
|
23.82 kg/m²
STANDARD_DEVIATION 4.085 • n=5 Participants
|
24.79 kg/m²
STANDARD_DEVIATION 4.033 • n=7 Participants
|
24.71 kg/m²
STANDARD_DEVIATION 3.947 • n=5 Participants
|
24.36 kg/m²
STANDARD_DEVIATION 4.057 • n=4 Participants
|
|
Surgery duration
|
9.2 minutes
STANDARD_DEVIATION 4.60 • n=5 Participants
|
9.0 minutes
STANDARD_DEVIATION 4.89 • n=7 Participants
|
11.1 minutes
STANDARD_DEVIATION 5.81 • n=5 Participants
|
9.4 minutes
STANDARD_DEVIATION 4.94 • n=4 Participants
|
PRIMARY outcome
Timeframe: 0-12 hoursPopulation: The ITT Population included all subjects who were treated with study drug and had at least 1 pain assessment after Time 0; it was the primary population for the efficacy analysis.
SPID12 was used to compare the test product (2 × 300 mg ibuprofen PR tablets) and comparator product (2 × 200 mg ibuprofen IR tablets three times a day \[TID\]) against the placebo product. An 11-point (0-10) numeric rating scale (NRS) for pain was used to assess pain intensity, where a higher score indicates a greater amount of pain. SPID12 was calculated using the summed pain intensity difference (change from Time 0) under the NRS-time curve from 15 minutes through 12 hours calculated using the linear trapezoidal rule and the actual time points, where Time 0 is the time of the first dose of study drug. The minimum value of SPID12 is 0 (no change in pain intensity from Time 0 to 12 hours); the theoretical maximum is 120 (if a patient had a score of 10 \[worst pain intensity\] at baseline, which decreased to 0 \[no pain\] at the next time point and remained at 0 after); a higher SPID12 score indicates a better outcome.
Outcome measures
| Measure |
Immediate Release Group
n=120 Participants
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
n=39 Participants
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Prolonged Release Group
n=120 Participants
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
|---|---|---|---|
|
Summed Pain Intensity Difference Over 0 to 12 Hours (SPID12) After Time 0
|
56.33 score on a scale*hours
Standard Deviation 18.769
|
19.11 score on a scale*hours
Standard Deviation 24.630
|
51.84 score on a scale*hours
Standard Deviation 21.457
|
SECONDARY outcome
Timeframe: 0-24 hoursPopulation: The ITT Population included all subjects who were treated with study drug and had at least 1 pain assessment after Time 0; it was the primary population for the efficacy analysis.
SPID24 was used to compare the test product (2 × 300 mg ibuprofen PR tablets BID) and comparator product (2 × 200 mg ibuprofen IR tablets TID) against the placebo product. An 11-point (0-10) numeric rating scale (NRS) for pain was used to assess pain intensity, where a higher score indicates a greater amount of pain. SPID24 was calculated using the summed pain intensity difference (change from Time 0) under the NRS-time curve from 15 minutes through 24 hours calculated using the linear trapezoidal rule and the actual time points, where Time 0 is the time of the first dose of study drug. The minimum value of SPID24 is 0 (no change in pain intensity from Time 0 to 24 hours); the theoretical maximum is 240 (if a patient had a score of 10 \[worst pain intensity\] at baseline, which decreased to 0 \[no pain\] at the next time point and remained at 0 after).
Outcome measures
| Measure |
Immediate Release Group
n=120 Participants
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
n=39 Participants
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Prolonged Release Group
n=120 Participants
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
|---|---|---|---|
|
Summed Pain Intensity Difference Over 0 to 24 Hours (SPID24) After Time 0
|
121.90 score on a scale*hours
Standard Deviation 37.263
|
64.32 score on a scale*hours
Standard Deviation 55.070
|
115.75 score on a scale*hours
Standard Deviation 46.146
|
SECONDARY outcome
Timeframe: 0-4 hoursPopulation: The ITT Population included all subjects who were treated with study drug and had at least 1 pain assessment after Time 0; it was the primary population for the efficacy analysis.
SPID4 was used to compare the test product (2 × 300 mg ibuprofen PR tablets BID) and comparator product (2 × 200 mg ibuprofen IR tablets TID) against the placebo product. An 11-point (0-10) numeric rating scale (NRS) for pain was used to assess pain intensity, where a higher score indicates a greater amount of pain. SPID4 was calculated using the summed pain intensity difference (change from Time 0) under the NRS-time curve from 15 minutes through 4 hours calculated using the linear trapezoidal rule and the actual time points, where Time 0 is the time of the first dose of study drug. The minimum value of SPID4 is 0 (no change in pain intensity from Time 0 to 4 hours); the theoretical maximum is 40 (if a patient had a score of 10 \[worst pain intensity\] at baseline, which decreased to 0 \[no pain\] at the next time point and remained at 0 after).
Outcome measures
| Measure |
Immediate Release Group
n=120 Participants
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
n=39 Participants
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Prolonged Release Group
n=120 Participants
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
|---|---|---|---|
|
Summed Pain Intensity Difference Over 0 to 4 Hours (SPID4) After Time 0
|
16.99 score on a scale*hours
Standard Deviation 7.884
|
1.24 score on a scale*hours
Standard Deviation 8.346
|
14.68 score on a scale*hours
Standard Deviation 9.752
|
SECONDARY outcome
Timeframe: 0-8 hoursPopulation: The ITT Population included all subjects who were treated with study drug and had at least 1 pain assessment after Time 0; it was the primary population for the efficacy analysis.
SPID8 was used to compare the test product (2 × 300 mg ibuprofen PR tablets BID) and comparator product (2 × 200 mg ibuprofen IR tablets TID) against the placebo product. An 11-point (0-10) numeric rating scale (NRS) for pain was used to assess pain intensity, where a higher score indicates a greater amount of pain. SPID8 was calculated using the summed pain intensity difference (change from Time 0) under the NRS-time curve from 15 minutes through 8 hours calculated using the linear trapezoidal rule and the actual time points, where Time 0 is the time of the first dose of study drug. The minimum value of SPID8 is 0 (no change in pain intensity from Time 0 to 8 hours); the theoretical maximum is 80 (if a patient had a score of 10 \[worst pain intensity\] at baseline, which decreased to 0 \[no pain\] at the next time point and remained at 0 after).
Outcome measures
| Measure |
Immediate Release Group
n=120 Participants
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
n=39 Participants
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Prolonged Release Group
n=120 Participants
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
|---|---|---|---|
|
Summed Pain Intensity Difference Over 0 to 8 Hours (SPID8) After Time 0
|
34.48 score on a scale*hours
Standard Deviation 13.001
|
11.00 score on a scale*hours
Standard Deviation 14.571
|
33.13 score on a scale*hours
Standard Deviation 16.195
|
SECONDARY outcome
Timeframe: 0-4 hoursPopulation: The ITT Population included all subjects who were treated with study drug and had at least 1 pain assessment after Time 0; it was the primary population for the efficacy analysis.
A 5-point categorical Pain Relief Scale (PRS) with choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4 was completed in response to the question "How much relief have you had since your starting pain?". Higher scores indicate a better outcome. TOTPAR4 is the total pain relief measured by the PRS from 15 minutes through 4 hours, calculated using the linear trapezoidal rule and the actual time points, where Time 0 is the time of the first dose of study drug. The minimum value of TOTPAR4 is 0 (no pain relief from Time 0 to 4 hours); the theoretical maximum is 16 (if a patient experiences maximum pain relief at all time points after baseline).
Outcome measures
| Measure |
Immediate Release Group
n=120 Participants
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
n=39 Participants
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Prolonged Release Group
n=120 Participants
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
|---|---|---|---|
|
Sum of Total Pain Relief Over 0 to 4 Hours (TOTPAR4) After Time 0
|
8.98 score on a scale*hours
Standard Deviation 3.365
|
1.98 score on a scale*hours
Standard Deviation 3.285
|
8.08 score on a scale*hours
Standard Deviation 4.337
|
SECONDARY outcome
Timeframe: 0-8 hoursPopulation: The ITT Population included all subjects who were treated with study drug and had at least 1 pain assessment after Time 0; it was the primary population for the efficacy analysis.
A 5-point categorical Pain Relief Scale (PRS) with choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4 was completed in response to the question "How much relief have you had since your starting pain?". Higher scores indicate a better outcome. TOTPAR8 is the total pain relief measured by the PRS from 15 minutes through 8 hours, calculated using the linear trapezoidal rule and the actual time points, where Time 0 is the time of the first dose of study drug. The minimum value of TOTPAR8 is 0 (no pain relief from Time 0 to 8 hours); the theoretical maximum is 32 (if a patient experiences maximum pain relief at all time points after baseline).
Outcome measures
| Measure |
Immediate Release Group
n=120 Participants
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
n=39 Participants
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Prolonged Release Group
n=120 Participants
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
|---|---|---|---|
|
Sum of Total Pain Relief Over 0 to 8 Hours (TOTPAR8) After Time 0
|
18.41 score on a scale*hours
Standard Deviation 5.764
|
7.89 score on a scale*hours
Standard Deviation 5.642
|
18.08 score on a scale*hours
Standard Deviation 7.314
|
SECONDARY outcome
Timeframe: 0-12 hoursPopulation: The ITT Population included all subjects who were treated with study drug and had at least 1 pain assessment after Time 0; it was the primary population for the efficacy analysis.
A 5-point categorical Pain Relief Scale (PRS) with choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4 was completed in response to the question "How much relief have you had since your starting pain?". Higher scores indicate a better outcome. TOTPAR12 is the total pain relief measured by the PRS from 15 minutes through 12 hours, calculated using the linear trapezoidal rule and the actual time points, where Time 0 is the time of the first dose of study drug. The minimum value of TOTPAR12 is 0 (no pain relief from Time 0 to 12 hours); the theoretical maximum is 48 (if a patient experiences maximum pain relief at all time points after baseline).
Outcome measures
| Measure |
Immediate Release Group
n=120 Participants
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
n=39 Participants
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Prolonged Release Group
n=120 Participants
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
|---|---|---|---|
|
Sum of Total Pain Relief Over 0 to 12 Hours (TOTPAR12) After Time 0
|
29.981 score on a scale*hours
Standard Deviation 8.538
|
12.76 score on a scale*hours
Standard Deviation 9.270
|
28.13 score on a scale*hours
Standard Deviation 9.981
|
SECONDARY outcome
Timeframe: 0-24 hoursPopulation: The ITT Population included all subjects who were treated with study drug and had at least 1 pain assessment after Time 0; it was the primary population for the efficacy analysis.
A 5-point categorical Pain Relief Scale (PRS) with choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4 was completed in response to the question "How much relief have you had since your starting pain?". Higher scores indicate a better outcome. TOTPAR24 is the total pain relief measured by the PRS from 15 minutes through 24 hours, calculated using the linear trapezoidal rule and the actual time points, where Time 0 is the time of the first dose of study drug. The minimum value of TOTPAR24 is 0 (no pain relief from Time 0 to 24 hours); the theoretical maximum is 96 (if a patient experiences maximum pain relief at all time points after baseline).
Outcome measures
| Measure |
Immediate Release Group
n=120 Participants
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
n=39 Participants
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Prolonged Release Group
n=120 Participants
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
|---|---|---|---|
|
Sum of Total Pain Relief Over 0 to 24 Hours (TOTPAR24) After Time 0
|
64.63 score on a scale*hours
Standard Deviation 16.774
|
36.96 score on a scale*hours
Standard Deviation 22.153
|
62.32 score on a scale*hours
Standard Deviation 20.504
|
SECONDARY outcome
Timeframe: 0-4 hoursPopulation: The ITT Population included all subjects who were treated with study drug and had at least 1 pain assessment after Time 0; it was the primary population for the efficacy analysis.
The summed pain relief and intensity difference (sum of TOTPAR and SPID \[SPRID\]) over 0 to 4 hours (SPRID4) was determined by calculating the difference in the PRS at the 4-hour time point and the 0-hour time point (TOTPAR4) and adding this value to the difference in the NRS for pain at the 4-hour time point and the 0-hour time point (SPID4). The minimum value of SPRID4 is 0; the theoretical maximum is 56; a higher SPRID4 score indicates a better outcome.
Outcome measures
| Measure |
Immediate Release Group
n=120 Participants
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
n=39 Participants
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Prolonged Release Group
n=120 Participants
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
|---|---|---|---|
|
Summed Pain Relief and Intensity Difference (Sum of TOTPAR and SPID [SPRID]) Over 0 to 4 Hours (SPRID4) After Time 0
|
25.97 score on a scale*hours
Standard Deviation 11.011
|
3.22 score on a scale*hours
Standard Deviation 11.464
|
22.76 score on a scale*hours
Standard Deviation 13.870
|
SECONDARY outcome
Timeframe: 0-8 hoursPopulation: The ITT Population included all subjects who were treated with study drug and had at least 1 pain assessment after Time 0; it was the primary population for the efficacy analysis.
The summed pain relief and intensity difference (sum of TOTPAR and SPID \[SPRID\]) over 0 to 8 hours (SPRID8) was determined by calculating the difference in the PRS at the 8-hour time point and the 0-hour time point (TOTPAR8) and adding this value to the difference in the NRS for pain at the 8-hour time point and the 0-hour time point (SPID8). The minimum value of SPRID8 is 0; the theoretical maximum is 112; a higher SPRID8 score indicates a better outcome.
Outcome measures
| Measure |
Immediate Release Group
n=120 Participants
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
n=39 Participants
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Prolonged Release Group
n=120 Participants
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
|---|---|---|---|
|
Summed Pain Relief and Intensity Difference (Sum of TOTPAR and SPID [SPRID]) Over 0 to 8 Hours (SPRID8) After Time 0
|
52.88 score on a scale*hours
Standard Deviation 18.156
|
18.89 score on a scale*hours
Standard Deviation 19.916
|
51.21 score on a scale*hours
Standard Deviation 22.985
|
SECONDARY outcome
Timeframe: 0-12 hoursPopulation: The ITT Population included all subjects who were treated with study drug and had at least 1 pain assessment after Time 0; it was the primary population for the efficacy analysis.
The summed pain relief and intensity difference (sum of TOTPAR and SPID \[SPRID\]) over 0 to 12 hours (SPRID12) was determined by calculating the difference in the PRS at the 12-hour time point and the 0-hour time point (TOTPAR12) and adding this value to the difference in the NRS for pain at the 12-hour time point and the 0-hour time point (SPID12). The minimum value of SPRID12 is 0; the theoretical maximum 168; a higher SPRID12 score indicates a better outcome.
Outcome measures
| Measure |
Immediate Release Group
n=120 Participants
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
n=39 Participants
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Prolonged Release Group
n=120 Participants
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
|---|---|---|---|
|
Summed Pain Relief and Intensity Difference (Sum of TOTPAR and SPID [SPRID]) Over 0 to 12 Hours (SPRID12) After Time 0
|
86.24 score on a scale*hours
Standard Deviation 26.260
|
31.87 score on a scale*hours
Standard Deviation 33.539
|
79.97 score on a scale*hours
Standard Deviation 30.643
|
SECONDARY outcome
Timeframe: 0-24 hoursPopulation: The ITT Population included all subjects who were treated with study drug and had at least 1 pain assessment after Time 0; it was the primary population for the efficacy analysis.
The summed pain relief and intensity difference (sum of TOTPAR and SPID \[SPRID\]) over 0 to 24 hours (SPRID24) was determined by calculating the difference in the PRS at the 24-hour time point and the 0-hour time point (TOTPAR24) and adding this value to the difference in the NRS for pain at the 24-hour time point and the 0-hour time point (SPID24). The minimum value of SPRID24 is 0; the theoretical maximum is 336; a higher SPRID24 score indicates a better outcome.
Outcome measures
| Measure |
Immediate Release Group
n=120 Participants
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
n=39 Participants
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Prolonged Release Group
n=120 Participants
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
|---|---|---|---|
|
Summed Pain Relief and Intensity Difference (Sum of TOTPAR and SPID [SPRID]) Over 0 to 24 Hours (SPRID24) After Time 0
|
186.53 score on a scale*hours
Standard Deviation 51.842
|
101.28 score on a scale*hours
Standard Deviation 76.562
|
178.07 score on a scale*hours
Standard Deviation 64.783
|
SECONDARY outcome
Timeframe: 0-8 hoursPopulation: The ITT Population included all subjects who were treated with study drug and had at least 1 pain assessment after Time 0; it was the primary population for the efficacy analysis.
A responder was defined as a subject with ≥30% improvement in pain intensity at the 8-hour assessment without rescue medication during the first 8 hours. An 11-point (0-10) numeric rating scale (NRS) for pain was used to assess pain intensity, where a higher score indicates a greater amount of pain.
Outcome measures
| Measure |
Immediate Release Group
n=120 Participants
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
n=39 Participants
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Prolonged Release Group
n=120 Participants
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
|---|---|---|---|
|
Number of Subjects With Response to Study Drug
|
76 Participants
|
5 Participants
|
81 Participants
|
SECONDARY outcome
Timeframe: 0-24 hoursPopulation: The ITT Population included all subjects who were treated with study drug and had at least 1 pain assessment after Time 0; it was the primary population for the efficacy analysis.
An 11-point (0-10) numeric rating scale (NRS) for pain was used to assess pain intensity, where a higher score indicates a greater amount of pain, and the PID (the difference in NRS pain intensity between each time point and Time 0) at each time point was calculated.
Outcome measures
| Measure |
Immediate Release Group
n=120 Participants
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
n=39 Participants
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Prolonged Release Group
n=120 Participants
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
|---|---|---|---|
|
Numeric Rating Scale (NRS) Pain Intensity Difference (PID) at Each Time Point After Time 0
PID 15 Minutes Post-dose
|
0.5 score on a scale
Standard Deviation 1.14
|
0.2 score on a scale
Standard Deviation 0.99
|
0.4 score on a scale
Standard Deviation 0.97
|
|
Numeric Rating Scale (NRS) Pain Intensity Difference (PID) at Each Time Point After Time 0
PID 30 Minutes Post-dose
|
1.5 score on a scale
Standard Deviation 1.90
|
0.3 score on a scale
Standard Deviation 1.34
|
1.4 score on a scale
Standard Deviation 1.79
|
|
Numeric Rating Scale (NRS) Pain Intensity Difference (PID) at Each Time Point After Time 0
PID 45 Minutes Post-dose
|
2.6 score on a scale
Standard Deviation 2.25
|
0.3 score on a scale
Standard Deviation 1.57
|
2.1 score on a scale
Standard Deviation 2.37
|
|
Numeric Rating Scale (NRS) Pain Intensity Difference (PID) at Each Time Point After Time 0
PID 1 Hour Post-dose
|
3.5 score on a scale
Standard Deviation 2.51
|
0.4 score on a scale
Standard Deviation 2.02
|
2.9 score on a scale
Standard Deviation 2.59
|
|
Numeric Rating Scale (NRS) Pain Intensity Difference (PID) at Each Time Point After Time 0
PID 1.5 Hours Post-dose
|
4.4 score on a scale
Standard Deviation 2.41
|
0.3 score on a scale
Standard Deviation 2.09
|
3.8 score on a scale
Standard Deviation 2.76
|
|
Numeric Rating Scale (NRS) Pain Intensity Difference (PID) at Each Time Point After Time 0
PID 2 Hours Post-dose
|
5.0 score on a scale
Standard Deviation 2.38
|
0.4 score on a scale
Standard Deviation 2.39
|
4.3 score on a scale
Standard Deviation 2.78
|
|
Numeric Rating Scale (NRS) Pain Intensity Difference (PID) at Each Time Point After Time 0
PID 3 Hours Post-dose
|
5.2 score on a scale
Standard Deviation 2.27
|
0.3 score on a scale
Standard Deviation 2.56
|
4.5 score on a scale
Standard Deviation 2.81
|
|
Numeric Rating Scale (NRS) Pain Intensity Difference (PID) at Each Time Point After Time 0
PID 4 Hours Post-dose
|
5.2 score on a scale
Standard Deviation 2.27
|
0.3 score on a scale
Standard Deviation 2.59
|
4.8 score on a scale
Standard Deviation 2.92
|
|
Numeric Rating Scale (NRS) Pain Intensity Difference (PID) at Each Time Point After Time 0
PID 5 Hours Post-dose
|
5.0 score on a scale
Standard Deviation 2.16
|
0.6 score on a scale
Standard Deviation 2.84
|
4.6 score on a scale
Standard Deviation 2.79
|
|
Numeric Rating Scale (NRS) Pain Intensity Difference (PID) at Each Time Point After Time 0
PID 6 Hours Post-dose
|
4.8 score on a scale
Standard Deviation 2.19
|
3.2 score on a scale
Standard Deviation 3.12
|
5.1 score on a scale
Standard Deviation 2.10
|
|
Numeric Rating Scale (NRS) Pain Intensity Difference (PID) at Each Time Point After Time 0
PID 7 Hours Post-dose
|
4.3 score on a scale
Standard Deviation 2.29
|
3.0 score on a scale
Standard Deviation 2.70
|
5.0 score on a scale
Standard Deviation 2.25
|
|
Numeric Rating Scale (NRS) Pain Intensity Difference (PID) at Each Time Point After Time 0
PID 8 Hours Post-dose
|
3.6 score on a scale
Standard Deviation 2.31
|
3.0 score on a scale
Standard Deviation 2.73
|
4.6 score on a scale
Standard Deviation 2.32
|
|
Numeric Rating Scale (NRS) Pain Intensity Difference (PID) at Each Time Point After Time 0
PID 10 Hours Post-dose
|
5.4 score on a scale
Standard Deviation 2.03
|
2.0 score on a scale
Standard Deviation 2.75
|
5.1 score on a scale
Standard Deviation 2.10
|
|
Numeric Rating Scale (NRS) Pain Intensity Difference (PID) at Each Time Point After Time 0
PID 12 Hours Post-dose
|
5.6 score on a scale
Standard Deviation 1.92
|
2.1 score on a scale
Standard Deviation 3.60
|
4.6 score on a scale
Standard Deviation 2.21
|
|
Numeric Rating Scale (NRS) Pain Intensity Difference (PID) at Each Time Point After Time 0
PID 16 Hours Post-dose
|
4.8 score on a scale
Standard Deviation 2.26
|
3.2 score on a scale
Standard Deviation 2.99
|
5.2 score on a scale
Standard Deviation 2.34
|
|
Numeric Rating Scale (NRS) Pain Intensity Difference (PID) at Each Time Point After Time 0
PID 24 Hours Post-dose
|
5.9 score on a scale
Standard Deviation 1.68
|
3.9 score on a scale
Standard Deviation 3.24
|
5.6 score on a scale
Standard Deviation 2.20
|
SECONDARY outcome
Timeframe: 0-24 hoursPopulation: The ITT Population included all subjects who were treated with study drug and had at least 1 pain assessment after Time 0; it was the primary population for the efficacy analysis.
Pain intensity score at each scheduled time point will be assessed using a numeric rating scale (NRS) for pain. An 11-point (0-10) numeric rating scale (NRS) for pain was used to assess pain intensity, where a higher score indicates a greater amount of pain.
Outcome measures
| Measure |
Immediate Release Group
n=120 Participants
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
n=39 Participants
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Prolonged Release Group
n=120 Participants
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
|---|---|---|---|
|
Pain Intensity Score at Each Scheduled Time Point After Time 0
Pain Intensity Score at Baseline
|
7.6 score on a scale
Standard Deviation 1.17
|
7.8 score on a scale
Standard Deviation 1.12
|
7.5 score on a scale
Standard Deviation 1.23
|
|
Pain Intensity Score at Each Scheduled Time Point After Time 0
Pain Intensity Score 15 Minutes Post-dose
|
7.1 score on a scale
Standard Deviation 1.61
|
7.6 score on a scale
Standard Deviation 1.33
|
7.1 score on a scale
Standard Deviation 1.59
|
|
Pain Intensity Score at Each Scheduled Time Point After Time 0
Pain Intensity Score 30 Minutes Post-dose
|
6.1 score on a scale
Standard Deviation 2.24
|
7.5 score on a scale
Standard Deviation 1.62
|
6.1 score on a scale
Standard Deviation 2.06
|
|
Pain Intensity Score at Each Scheduled Time Point After Time 0
Pain Intensity Score 45 Minutes Post-dose
|
5.0 score on a scale
Standard Deviation 2.57
|
7.6 score on a scale
Standard Deviation 1.74
|
5.5 score on a scale
Standard Deviation 2.50
|
|
Pain Intensity Score at Each Scheduled Time Point After Time 0
Pain Intensity Score 1 Hour Post-dose
|
4.0 score on a scale
Standard Deviation 2.67
|
7.4 score on a scale
Standard Deviation 2.06
|
4.7 score on a scale
Standard Deviation 2.68
|
|
Pain Intensity Score at Each Scheduled Time Point After Time 0
Pain Intensity Score 1.5 Hours Post-dose
|
3.2 score on a scale
Standard Deviation 2.48
|
7.5 score on a scale
Standard Deviation 2.08
|
3.8 score on a scale
Standard Deviation 2.79
|
|
Pain Intensity Score at Each Scheduled Time Point After Time 0
Pain Intensity Score 2 Hours Post-dose
|
2.6 score on a scale
Standard Deviation 2.39
|
7.4 score on a scale
Standard Deviation 2.37
|
3.2 score on a scale
Standard Deviation 2.79
|
|
Pain Intensity Score at Each Scheduled Time Point After Time 0
Pain Intensity Score 3 Hours Post-dose
|
2.4 score on a scale
Standard Deviation 2.26
|
7.6 score on a scale
Standard Deviation 2.46
|
2.9 score on a scale
Standard Deviation 2.84
|
|
Pain Intensity Score at Each Scheduled Time Point After Time 0
Pain Intensity Score 4 Hours Post-dose
|
2.3 score on a scale
Standard Deviation 2.30
|
7.6 score on a scale
Standard Deviation 2.52
|
2.7 score on a scale
Standard Deviation 2.89
|
|
Pain Intensity Score at Each Scheduled Time Point After Time 0
Pain Intensity Score 5 Hours Post-dose
|
2.6 score on a scale
Standard Deviation 2.28
|
7.2 score on a scale
Standard Deviation 2.71
|
2.9 score on a scale
Standard Deviation 2.88
|
|
Pain Intensity Score at Each Scheduled Time Point After Time 0
Pain Intensity Score 6 Hours Post-dose
|
2.8 score on a scale
Standard Deviation 2.16
|
4.7 score on a scale
Standard Deviation 2.78
|
2.4 score on a scale
Standard Deviation 2.05
|
|
Pain Intensity Score at Each Scheduled Time Point After Time 0
Pain Intensity Score 7 Hours Post-dose
|
3.3 score on a scale
Standard Deviation 2.34
|
4.8 score on a scale
Standard Deviation 2.53
|
2.5 score on a scale
Standard Deviation 2.32
|
|
Pain Intensity Score at Each Scheduled Time Point After Time 0
Pain Intensity Score 8 Hours Post-dose
|
4.0 score on a scale
Standard Deviation 2.48
|
4.8 score on a scale
Standard Deviation 2.54
|
2.9 score on a scale
Standard Deviation 2.46
|
|
Pain Intensity Score at Each Scheduled Time Point After Time 0
Pain Intensity Score 10 Hours Post-dose
|
2.2 score on a scale
Standard Deviation 1.92
|
5.8 score on a scale
Standard Deviation 2.53
|
2.4 score on a scale
Standard Deviation 2.34
|
|
Pain Intensity Score at Each Scheduled Time Point After Time 0
Pain Intensity Score 12 Hours Post-dose
|
2.0 score on a scale
Standard Deviation 1.80
|
5.7 score on a scale
Standard Deviation 3.18
|
2.9 score on a scale
Standard Deviation 2.30
|
|
Pain Intensity Score at Each Scheduled Time Point After Time 0
Pain Intensity Score 16 Hours Post-dose
|
2.8 score on a scale
Standard Deviation 2.23
|
4.6 score on a scale
Standard Deviation 2.74
|
2.3 score on a scale
Standard Deviation 2.26
|
|
Pain Intensity Score at Each Scheduled Time Point After Time 0
Pain Intensity Score 24 Hours Post-dose
|
1.7 score on a scale
Standard Deviation 1.53
|
3.9 score on a scale
Standard Deviation 3.01
|
1.8 score on a scale
Standard Deviation 2.09
|
SECONDARY outcome
Timeframe: 0-24 hoursPopulation: The ITT Population included all subjects who were treated with study drug and had at least 1 pain assessment after Time 0; it was the primary population for the efficacy analysis.
Pain relief score at each scheduled time point after Time 0 was measured using the Pain Relief Scale (PRS). The PRS was used to measure pain relief and is a 5-point categorical scale, with response choices of: none = 0; a little = 1; some = 2; a lot = 3; and complete = 4 to be completed in response to the question "How much relief have you had since your starting pain?". Higher scores indicate a better outcome.
Outcome measures
| Measure |
Immediate Release Group
n=120 Participants
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
n=39 Participants
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Prolonged Release Group
n=120 Participants
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
|---|---|---|---|
|
Pain Relief at Each Scheduled Time Point After Time 0
24 Hours Post-dose
|
3.1 score on a scale
Standard Deviation 0.74
|
2.1 score on a scale
Standard Deviation 1.43
|
3.0 score on a scale
Standard Deviation 0.96
|
|
Pain Relief at Each Scheduled Time Point After Time 0
15 Minutes Post-dose
|
0.4 score on a scale
Standard Deviation 0.67
|
0.3 score on a scale
Standard Deviation 0.44
|
0.3 score on a scale
Standard Deviation 0.60
|
|
Pain Relief at Each Scheduled Time Point After Time 0
30 Minutes Post-dose
|
1.0 score on a scale
Standard Deviation 0.93
|
0.4 score on a scale
Standard Deviation 0.72
|
0.9 score on a scale
Standard Deviation 0.92
|
|
Pain Relief at Each Scheduled Time Point After Time 0
45 Minutes Post-dose
|
1.6 score on a scale
Standard Deviation 1.15
|
0.5 score on a scale
Standard Deviation 0.79
|
1.3 score on a scale
Standard Deviation 1.10
|
|
Pain Relief at Each Scheduled Time Point After Time 0
1 Hour Post-dose
|
1.9 score on a scale
Standard Deviation 1.21
|
0.6 score on a scale
Standard Deviation 0.88
|
1.7 score on a scale
Standard Deviation 1.22
|
|
Pain Relief at Each Scheduled Time Point After Time 0
1.5 Hours Post-dose
|
2.4 score on a scale
Standard Deviation 1.13
|
0.5 score on a scale
Standard Deviation 0.88
|
2.1 score on a scale
Standard Deviation 1.26
|
|
Pain Relief at Each Scheduled Time Point After Time 0
2 Hours Post-dose
|
2.6 score on a scale
Standard Deviation 1.08
|
0.6 score on a scale
Standard Deviation 1.00
|
2.3 score on a scale
Standard Deviation 1.22
|
|
Pain Relief at Each Scheduled Time Point After Time 0
3 Hours Post-dose
|
2.7 score on a scale
Standard Deviation 0.97
|
0.5 score on a scale
Standard Deviation 1.00
|
2.5 score on a scale
Standard Deviation 1.31
|
|
Pain Relief at Each Scheduled Time Point After Time 0
4 Hours Post-dose
|
2.7 score on a scale
Standard Deviation 1.00
|
0.5 score on a scale
Standard Deviation 0.97
|
2.6 score on a scale
Standard Deviation 1.39
|
|
Pain Relief at Each Scheduled Time Point After Time 0
5 Hours Post-dose
|
2.6 score on a scale
Standard Deviation 1.01
|
0.7 score on a scale
Standard Deviation 1.10
|
2.5 score on a scale
Standard Deviation 1.34
|
|
Pain Relief at Each Scheduled Time Point After Time 0
6 Hours Post-dose
|
2.5 score on a scale
Standard Deviation 0.99
|
1.8 score on a scale
Standard Deviation 1.29
|
2.7 score on a scale
Standard Deviation 0.96
|
|
Pain Relief at Each Scheduled Time Point After Time 0
7 Hours Post-dose
|
2.3 score on a scale
Standard Deviation 1.12
|
1.7 score on a scale
Standard Deviation 1.21
|
2.7 score on a scale
Standard Deviation 1.06
|
|
Pain Relief at Each Scheduled Time Point After Time 0
8 Hours Post-dose
|
2.1 score on a scale
Standard Deviation 1.15
|
1.7 score on a scale
Standard Deviation 1.23
|
2.5 score on a scale
Standard Deviation 1.11
|
|
Pain Relief at Each Scheduled Time Point After Time 0
10 Hours Post-dose
|
2.9 score on a scale
Standard Deviation 0.94
|
1.3 score on a scale
Standard Deviation 1.16
|
2.7 score on a scale
Standard Deviation 1.06
|
|
Pain Relief at Each Scheduled Time Point After Time 0
12 Hours Post-dose
|
2.9 score on a scale
Standard Deviation 0.88
|
1.2 score on a scale
Standard Deviation 1.27
|
2.5 score on a scale
Standard Deviation 1.04
|
|
Pain Relief at Each Scheduled Time Point After Time 0
16 Hours Post-dose
|
2.6 score on a scale
Standard Deviation 1.03
|
1.8 score on a scale
Standard Deviation 1.34
|
2.8 score on a scale
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: 0-24 hoursPopulation: The ITT Population included all subjects who were treated with study drug and had at least 1 pain assessment after Time 0; it was the primary population for the efficacy analysis.
Peak pain relief at each time point was measured using the Pain Relief Scale (PRS). The PRS was used to measure pain relief and is a 5-point categorical scale, response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4 to be completed in response to the question "How much relief have you had since your starting pain?". Higher scores indicate a better outcome. For each subject, peak pain relief was calculated as the maximum pain relief over all PRS assessments, and summarised by counts (and percentages) for each PRS score. Peak pain relief was calculated from PRS scores that were adjusted for rescue medication usage using windowed worst observation carried forward (WOCF).
Outcome measures
| Measure |
Immediate Release Group
n=120 Participants
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
n=39 Participants
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Prolonged Release Group
n=120 Participants
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
|---|---|---|---|
|
Peak Pain Relief
None
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Peak Pain Relief
A little relief
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Peak Pain Relief
Some relief
|
3 Participants
|
8 Participants
|
8 Participants
|
|
Peak Pain Relief
A lot of relief
|
62 Participants
|
23 Participants
|
49 Participants
|
|
Peak Pain Relief
Complete relief
|
53 Participants
|
6 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: 0-24 hoursPopulation: The ITT Population included all subjects who were treated with study drug and had at least 1 pain assessment after Time 0; it was the primary population for the efficacy analysis.
Two stopwatches were started immediately after the subject swallowed the study drug. Subjects were instructed to, "Stop the first stopwatch when you first feel any pain relief whatsoever. This does not mean you feel completely better, although you might, but when you first feel any relief in the pain you have now" (perceptible pain relief), and then, "Stop the second stopwatch when you feel the pain relief is meaningful to you" (meaningful pain relief). If the stopwatches were not stopped within 8 hours after Time 0 use of the stopwatches was discontinued. If the subject had meaningful pain relief (i.e., pressed both stopwatches) then time to onset of analgesia was date/time of perceptible pain relief - date/time of the first dose of study drug. Values presented are from Kaplan-Meier estimates.
Outcome measures
| Measure |
Immediate Release Group
n=120 Participants
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
n=39 Participants
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Prolonged Release Group
n=120 Participants
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
|---|---|---|---|
|
Time to Onset of Analgesia (Measured as Time to Perceptible Pain Relief Confirmed by Time to Meaningful Pain Relief) Using Double Stopwatch
|
0.47 Hours
Interval 0.37 to 0.51
|
NA Hours
Not estimable due to insufficient number of participants with events.
|
0.48 Hours
Interval 0.42 to 0.53
|
SECONDARY outcome
Timeframe: 0-8 hoursPopulation: The ITT Population included all subjects who were treated with study drug and had at least 1 pain assessment after Time 0; it was the primary population for the efficacy analysis.
Two stopwatches were started immediately after the subject swallowed the study drug. Subjects were instructed to, "Stop the first stopwatch when you first feel any pain relief whatsoever. This does not mean you feel completely better, although you might, but when you first feel any relief in the pain you have now" (perceptible pain relief). Time to first perceptible pain relief was date/time of the first reported pain relief (any) as assessed by the subject (i.e., when the subject stopped the first stopwatch, irrespective of the second) - date/time of the first dose of study drug. If the stopwatch were not stopped within 8 hours after Time 0, use of the stopwatches was discontinued. Values presented are from Kaplan-Meier estimates.
Outcome measures
| Measure |
Immediate Release Group
n=120 Participants
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
n=39 Participants
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Prolonged Release Group
n=120 Participants
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
|---|---|---|---|
|
Time to First Perceptible Pain Relief
|
0.46 Hours
Interval 0.04 to 3.96
|
1.01 Hours
Interval 0.08 to 3.28
|
0.47 Hours
Interval 0.09 to 5.11
|
SECONDARY outcome
Timeframe: 0-8 hoursPopulation: The ITT Population included all subjects who were treated with study drug and had at least 1 pain assessment after Time 0; it was the primary population for the efficacy analysis.
Two stopwatches were started immediately after the subject swallowed the study drug. Each subject was instructed, "Stop the second stopwatch when you feel the pain relief is meaningful to you" (meaningful pain relief). Time to meaningful pain relief was the date/time of the first reported meaningful (subjective) pain relief as assessed by the subject (i.e., when the subject stopped the second stopwatch) - date/time of the first dose of study drug. If the stopwatches were not stopped within 8 hours after Time 0 use of the stopwatches was discontinued. Values presented are from Kaplan-Meier estimates.
Outcome measures
| Measure |
Immediate Release Group
n=120 Participants
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
n=39 Participants
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Prolonged Release Group
n=120 Participants
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
|---|---|---|---|
|
Time to Meaningful Pain Relief
|
0.99 Hours
Interval 0.29 to 8.0
|
2.88 Hours
Interval 0.32 to 7.95
|
1.25 Hours
Interval 0.21 to 8.0
|
SECONDARY outcome
Timeframe: 0-24 hoursPopulation: The ITT Population included all subjects who were treated with study drug and had at least 1 pain assessment after Time 0; it was the primary population for the efficacy analysis.
The PRS was used to measure pain relief and is a 5-point categorical scale, with response choices of: none = 0; a little = 1; some = 2; a lot = 3; and complete = 4 to be completed in response to the question "How much relief have you had since your starting pain?". A higher score indicates greater pain. Time to peak pain relief was the time when peak pain relief (PPR) first occurred. Values presented are from Kaplan-Meier estimates.
Outcome measures
| Measure |
Immediate Release Group
n=120 Participants
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
n=39 Participants
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Prolonged Release Group
n=120 Participants
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
|---|---|---|---|
|
Time to Peak Pain Relief
|
2.02 Hours
Interval 1.98 to 3.0
|
5.02 Hours
Interval 3.02 to 11.97
|
3.00 Hours
Interval 2.03 to 3.97
|
SECONDARY outcome
Timeframe: 0-24 hoursPopulation: The ITT Population included all subjects who were treated with study drug and had at least 1 pain assessment after Time 0; it was the primary population for the efficacy analysis.
After randomisation and administration of study drug, paracetamol/acetaminophen (1000 mg) was permitted as the initial rescue medication. Subjects were encouraged to wait at least 60 minutes after receiving study drug before taking rescue medication. If acetaminophen rescue medication was not effective in relieving the subject's pain, 5 mg oxycodone rescue medication was administered at the discretion of the investigator. At the investigator's discretion, repeat doses of rescue medication were also administered as required.
Outcome measures
| Measure |
Immediate Release Group
n=120 Participants
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
n=39 Participants
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Prolonged Release Group
n=120 Participants
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
|---|---|---|---|
|
Number of Subjects Using Rescue Medication
|
19 Participants
|
32 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 0-24 hoursPopulation: The ITT Population included all subjects who were treated with study drug and had at least 1 pain assessment after Time 0; it was the primary population for the efficacy analysis.
Time to first use of rescue medication, in hours.
Outcome measures
| Measure |
Immediate Release Group
n=120 Participants
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
n=39 Participants
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Prolonged Release Group
n=120 Participants
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
|---|---|---|---|
|
Time to First Use of Rescue Medication (Median and 95% Confidence Interval)
|
NA hours
Median was not reached.
|
1.37 hours
Interval 1.2 to 2.38
|
NA hours
Median was not reached.
|
SECONDARY outcome
Timeframe: 0-24 hoursPopulation: The ITT Population included all subjects who were treated with study drug and had at least 1 pain assessment after Time 0; it was the primary population for the efficacy analysis. The unit of measure is the hazard ratio of the PR and IR Groups versus the Placebo Group; data are not relevant for the Placebo Group.
Time to first use of rescue medication, in hours. Values presented are the hazard ratios, calculated from Cox proportional hazards model with treatment group as a categorical factor and baseline pain as a continuous covariate. A hazard ratio of \<1 means that when subjects did take rescue medication, subjects in the ibuprofen groups refrained from taking rescue medication for longer than subjects in the placebo group. A hazard ratio of \>1 means that when subjects did take rescue medication, subjects in the placebo group refrained from taking rescue medication for longer than subjects in the ibuprofen groups.
Outcome measures
| Measure |
Immediate Release Group
n=120 Participants
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
n=39 Participants
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Prolonged Release Group
n=120 Participants
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
|---|---|---|---|
|
Time to First Use of Rescue Medication (Hazard Ratios Versus Placebo)
|
0.10 Hazard ratio versus placebo
Interval 0.06 to 0.18
|
NA Hazard ratio versus placebo
Placebo is used as the reference group for the hazard ratio.
|
0.17 Hazard ratio versus placebo
Interval 0.1 to 0.29
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0-10 daysIncidence of treatment emergent adverse events (TEAEs). Data listings will be provided for protocol specified safety data.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 0-10 daysIncidence of changes in vital sign measurements. Descriptive statistics will be provided at each scheduled time point for each treatment group. Changes from Baseline for vital signs will be calculated for each subject.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 0-10 daysIncidence of changes in vital sign measurements. Descriptive statistics will be provided at each scheduled time point for each treatment group. Changes from Baseline for vital signs will be calculated for each subject.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 0-10 daysIncidence of changes in vital sign measurements. Descriptive statistics will be provided at each scheduled time point for each treatment group. Changes from Baseline for vital signs will be calculated for each subject.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 0-10 daysIncidence of changes in vital sign measurements. Descriptive statistics will be provided at each scheduled time point for each treatment group. Changes from Baseline for vital signs will be calculated for each subject.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 0-24 hoursPatient's global evaluation of study drug using 5 point categorical scale, response choices of 0 = poor, 1 = fair, 2 = good, 3 = very good, or 4 = excellent to be completed by the patient in response to the question "How effective do you think the study drug is as a treatment for pain?". Subjects will complete the global evaluation of study drug 24 hours after Time 0 or immediately before the first dose of rescue medication (whichever occurs first).
Outcome measures
Outcome data not reported
Adverse Events
Prolonged Release Group
Immediate Release Group
Placebo Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Prolonged Release Group
n=120 participants at risk
2 × 300 mg ibuprofen PR tablets at Hours 0 and 12
2 × placebo of PR tablets at Hours 8 and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
Immediate Release Group
n=120 participants at risk
2 × 200 mg ibuprofen IR tablets at Hours 0, 8, and 16
2 × placebo of IR tablets at Hour 12
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
|
Placebo Group
n=39 participants at risk
2 × placebo of PR tablets at Hours 0, 8, 12, and 16
2 × placebo of IR tablets at Hours 0, 8, 12, and 16
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.83%
1/120 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
1.7%
2/120 • Number of events 2 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
15.4%
6/39 • Number of events 8 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.83%
1/120 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.00%
0/39 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.83%
1/120 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.83%
1/120 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.00%
0/39 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.83%
1/120 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.00%
0/39 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
1.7%
2/120 • Number of events 5 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
7.7%
3/39 • Number of events 6 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
|
General disorders
Chills
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
2.6%
1/39 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
|
General disorders
Facial pain
|
0.83%
1/120 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.00%
0/39 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
|
General disorders
Puncture site haemorrhage
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.83%
1/120 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.00%
0/39 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
|
General disorders
Swelling face
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.83%
1/120 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
2.6%
1/39 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.83%
1/120 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.00%
0/39 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
|
Infections and infestations
Alveolar osteitis
|
0.83%
1/120 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.83%
1/120 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
2.6%
1/39 • Number of events 2 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
2.6%
1/39 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.83%
1/120 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.83%
1/120 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.00%
0/39 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.83%
1/120 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.00%
0/39 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
|
Injury, poisoning and procedural complications
Product administration error
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
2.6%
1/39 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
2.6%
1/39 • Number of events 2 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
|
Nervous system disorders
Headache
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
1.7%
2/120 • Number of events 2 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
2.6%
1/39 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
|
Nervous system disorders
Migraine
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
2.6%
1/39 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.83%
1/120 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
2.6%
1/39 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
|
Nervous system disorders
Tremor
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.83%
1/120 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
2.6%
1/39 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.83%
1/120 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.00%
0/39 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.83%
1/120 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.00%
0/39 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.83%
1/120 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.83%
1/120 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.00%
0/39 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.83%
1/120 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.83%
1/120 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.00%
0/39 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.83%
1/120 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.00%
0/39 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
2.6%
1/39 • Number of events 1 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
0.00%
0/120 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
5.1%
2/39 • Number of events 4 • Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here.
|
Additional Information
Clinical Project Manager
Reckitt Benckiser (Health) Limited
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place