Pain
Conditions
Keywords
ibuprofen, acetaminophen, pain, molar extraction
Brief summary
This study will determine the overall analgesic efficacy of three different fixed dose ibuprofen plus acetaminophen formulations compared to ibuprofen alone and to placebo.
Interventions
Two caplets of ibuprofen 100 mg plus acetaminophen 250 mg
DRUGIbuprofen
Two caplets of ibuprofen 200 mg
DRUGPlacebo
Two caplets of placebo
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Males and females 16 to 40 years of age * Moderate to severe post-operative pain following surgical extraction of three or more third molar teeth
Exclusion criteria
* Presence of history of significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic or metabolic disorder * Pregnant or breastfeeding females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 8 Hours (SPRID 0-8) | From 0 hour up to 8 hours post-dose | SPRID4:Time-weighted sum of pain relief rating (PRR) and pain intensity difference (PID) based on 4 point categorical severity rating scale (PRID) over 8 hours.SPRID 0-8 score range:-8 (worst score) to 56 (best score).PRID: sum of PRR and PID at each time point.PRID score range:-1= worst score to 7= best score.PID4 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 \[none\] to 3 \[severe\]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -1 (worst score) to 3 (best score).PRR assessed on 5-point categorical scale with range:0 =no relief to 4 =complete relief. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Confirmed First Perceptible Relief | From 0 hour up to 12 hours post-dose | Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labelled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study. Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure (defined as participant taking rescue medication, or discontinuing due to lack of efficacy) prior to depressing the first stopwatch or until the time of withdrawal (discontinuation). |
| Pain Relief Rating Score (PRR) | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose | Participants answered a question: how much relief do you have from your starting pain? on a 5-point categorical pain relief rating scale. Scale ranges from 0= no relief to 4= complete relief. |
| Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose | PID4: baseline pain severity score minus pain severity score at a given time point. Pain intensity was assessed on a 4-point categorical pain severity rating scale. PID4 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 \[no pain\] to 3 \[worst possible pain\]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID4: -1 (worst score) to 3 (best score). |
| Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose | PID11: baseline pain severity score minus pain severity score at a given time point. Pain intensity was assessed on an 11-point numerical pain severity rating scale. PID11 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID11: -5 (worst score) to 10 (best score). |
| Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose | 0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose | TOTPAR: time-weighted sum of PRR scores over 2, 6, 8 and 12 hours. TOTPAR score range was 0 (worst score) to 8 (best score) for TOTPAR 0-2, 0 (worst score) to 24 (best score) for TOTPAR 0-6, 0 (worst score) to 32 (best score) for TOTPAR 0-8, 0 (worst score) to 48 (best score) for TOTPAR 0-12. PRR was assessed on a 5-point categorical pain relief rating scale where 0= No relief to 4= Complete relief. |
| Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose | PRID4: sum of PID and PRR at each post-dose time points up to 12 hours. Score range for PRID: -1(worst score) to 7(best score). PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 \[no pain\] to 3 \[worst possible pain\]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID4: -1 (worst score) to 3 (best score). PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief. |
| Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose | Pain intensity was assessed on a 4-point categorical pain severity rating scale. SPID4: Time-weighted sum of PID over post-dose time points. SPID4 score range was -2 (worst score) to 6 (best score) for SPID 0-2, -6 (worst score) to 18 (best score) for SPID 0-6, -8 (worst score) to 24 (best score) for SPID 0-8, -12 (worst score) to 36 (best score) for SPID 0-12. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 \[none\] to 3 \[severe\]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -1 (worst score) to 3 (best score). |
| Time to Onset of Meaningful Pain Relief | From 0 hour up to 12 hours post-dose | Participants evaluated time to meaningful relief by stopping a second stopwatch labelled as meaningful relief at the moment they first began to experience meaningful relief. Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch. Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy. |
| Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose | 0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dose | SPRID4: Time-weighted sum of PRR and PID based on 4 point categorical pain severity rating scale (PRID) with score range: -2(worst score) to 14 (best score) for SPRID 0-2, -6 (worst score) to 42 (best score) for SPRID 0-6 and -12 (worst score) to 84 (best score) for SPRID 0-12. PRID: sum of PID and PRR at post-dose time point with score range: -1 (worst score) to 7 (best score). PID calculated by subtracting pain intensity score at post-dose time points (score range: 0 \[none\] to 3 \[severe\]) from baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline score of at least moderate were included). PID total possible score range: -1 (worst score) to 3(best score). PRR assessed on 5-point categorical scale with range: 0 =no relief to 4 =complete relief. |
| Cumulative Percentage of Participants With Meaningful Relief | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose | Percentage of participants with meaningful relief was reported. Participants evaluated time to meaningful relief by stopping a second stopwatch labeled meaningful relief at the moment they first began to experience meaningful relief. Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch. Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy. |
| Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose | Percentage of participants with confirmed first perceptible relief was reported. Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labelled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study. Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure prior to depressing the first stopwatch or until the time of withdrawal (discontinuation). Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy. |
| Time to Treatment Failure | From 0 hour up to 12 hours post-dose | Time to treatment failure was defined as the time interval from the study drug administration up to the first documentation of treatment failure. Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first. |
| Cumulative Percentage of Participants With Treatment Failure | 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose | Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first. Percentage of participants who had treatment failure were reported. |
| Participant Global Evaluation of Study Medication | 12 hour | Participant global evaluation of study medication was performed at the 12-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0= Very poor, 1= Poor, 2= Fair, 3= Good, 4= Very Good and 5= Excellent. |
| Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose | Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11: Time-weighted sum of PID scores over 12 hours. SPID11 score range was -10 (worst score) to 20 (best score) for SPID 0-2, -30 (worst score) to 60 (best score) for SPID 0-6, -40 (worst score) to 80 (best score) for SPID 0-8, -60 (worst score) to 120 (best score) for SPID 0-12. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received Placebo as single oral dose caplets during the 12 hours study. | 30 |
| Ibuprofen 200 mg + Acetaminophen 500 mg Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study. | 90 |
| Ibuprofen 250 mg + Acetaminophen 500 mg Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study. | 93 |
| Ibuprofen 300 mg + Acetaminophen 500 mg Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study. | 89 |
| Ibuprofen 400 mg Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study. | 92 |
| Total | 394 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Ibuprofen 200 mg + Acetaminophen 500 mg | Ibuprofen 250 mg + Acetaminophen 500 mg | Ibuprofen 300 mg + Acetaminophen 500 mg | Ibuprofen 400 mg | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 18.3 years STANDARD_DEVIATION 2.6 | 17.7 years STANDARD_DEVIATION 1.8 | 18.4 years STANDARD_DEVIATION 2.1 | 17.8 years STANDARD_DEVIATION 1.8 | 18.4 years STANDARD_DEVIATION 1.9 | 18.1 years STANDARD_DEVIATION 2 |
| Sex: Female, Male Female | 15 Participants | 46 Participants | 50 Participants | 43 Participants | 46 Participants | 200 Participants |
| Sex: Female, Male Male | 15 Participants | 44 Participants | 43 Participants | 46 Participants | 46 Participants | 194 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 15 / 30 | 33 / 90 | 27 / 93 | 22 / 89 | 30 / 92 |
| serious Total, serious adverse events | 0 / 30 | 0 / 90 | 0 / 93 | 0 / 89 | 0 / 92 |
Outcome results
Primary
Time-Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 8 Hours (SPRID 0-8)
SPRID4:Time-weighted sum of pain relief rating (PRR) and pain intensity difference (PID) based on 4 point categorical severity rating scale (PRID) over 8 hours.SPRID 0-8 score range:-8 (worst score) to 56 (best score).PRID: sum of PRR and PID at each time point.PRID score range:-1= worst score to 7= best score.PID4 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 \[none\] to 3 \[severe\]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -1 (worst score) to 3 (best score).PRR assessed on 5-point categorical scale with range:0 =no relief to 4 =complete relief.
Time frame: From 0 hour up to 8 hours post-dose
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Time-Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 8 Hours (SPRID 0-8) | 5.0 units on a scale | Standard Deviation 13.2 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Time-Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 8 Hours (SPRID 0-8) | 30.8 units on a scale | Standard Deviation 12.7 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 8 Hours (SPRID 0-8) | 29.6 units on a scale | Standard Deviation 15.6 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Time-Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 8 Hours (SPRID 0-8) | 31.7 units on a scale | Standard Deviation 14.6 |
| Ibuprofen 400 mg | Time-Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 8 Hours (SPRID 0-8) | 28.8 units on a scale | Standard Deviation 15.3 |
Comparison: Treatment difference and 95 percent (%) Confidence interval (CI) were based on Least square mean (LSM) from analysis of variance (ANOVA) with treatment, baseline categorical pain severity rating (PSR), gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [20.33, 32.22]ANOVA
Comparison: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [18.44, 30.29]ANOVA
Comparison: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [21.53, 33.42]ANOVA
Comparison: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [18.93, 30.78]ANOVA
Comparison: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.50195% CI: [-2.73, 5.58]ANOVA
Comparison: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.81795% CI: [-4.61, 3.64]ANOVA
Comparison: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.21695% CI: [-1.53, 6.78]ANOVA
Secondary
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
Percentage of participants with confirmed first perceptible relief was reported. Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labelled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study. Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure prior to depressing the first stopwatch or until the time of withdrawal (discontinuation). Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.
Time frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 6 hour | 20.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 2 hour | 20.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 5 hour | 20.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 4 hour | 20.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 3 hour | 20.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 10 hour | 20.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 0.25 hour | 3.3 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 9 hour | 20.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 0.5 hour | 10.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 8 hour | 20.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 1 hour | 16.7 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 11 hour | 20.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 7 hour | 20.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 1.5 hour | 16.7 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 12 hour | 20.0 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 1 hour | 88.9 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 8 hour | 91.1 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 2 hour | 91.1 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 12 hour | 91.1 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 6 hour | 91.1 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 0.5 hour | 73.3 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 11 hour | 91.1 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 3 hour | 91.1 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 5 hour | 91.1 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 10 hour | 91.1 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 7 hour | 91.1 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 9 hour | 91.1 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 1.5 hour | 91.1 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 0.25 hour | 26.7 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 4 hour | 91.1 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 11 hour | 88.2 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 4 hour | 88.2 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 12 hour | 88.2 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 0.25 hour | 18.3 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 0.5 hour | 66.7 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 1 hour | 83.9 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 1.5 hour | 86.0 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 2 hour | 88.2 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 3 hour | 88.2 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 5 hour | 88.2 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 6 hour | 88.2 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 7 hour | 88.2 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 8 hour | 88.2 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 9 hour | 88.2 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 10 hour | 88.2 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 1.5 hour | 89.9 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 8 hour | 89.9 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 1 hour | 88.8 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 0.25 hour | 28.1 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 10 hour | 89.9 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 11 hour | 89.9 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 9 hour | 89.9 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 7 hour | 89.9 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 12 hour | 89.9 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 3 hour | 89.9 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 6 hour | 89.9 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 0.5 hour | 77.5 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 4 hour | 89.9 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 5 hour | 89.9 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 2 hour | 89.9 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 11 hour | 85.9 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 5 hour | 85.9 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 1.5 hour | 84.8 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 6 hour | 85.9 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 1 hour | 80.4 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 10 hour | 85.9 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 7 hour | 85.9 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 0.25 hour | 19.6 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 9 hour | 85.9 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 8 hour | 85.9 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 0.5 hour | 63.0 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 12 hour | 85.9 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 3 hour | 85.9 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 2 hour | 85.9 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 4 hour | 85.9 percentage of participants |
Comparison: 2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [50.16, 81.74]Cochran-Mantel-Haenszel
Comparison: 0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.00395% CI: [13.32, 34.67]Cochran-Mantel-Haenszel
Comparison: 0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.04895% CI: [4.59, 25.07]Cochran-Mantel-Haenszel
Comparison: 0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.00595% CI: [13.43, 36.53]Cochran-Mantel-Haenszel
Comparison: 0.25 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.0395% CI: [6.25, 26.88]Cochran-Mantel-Haenszel
Comparison: 0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.26995% CI: [-4.8, 18.53]Cochran-Mantel-Haenszel
Comparison: 0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.73595% CI: [-13.34, 9.43]Cochran-Mantel-Haenszel
Comparison: 0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.17695% CI: [-3.88, 21.04]Cochran-Mantel-Haenszel
Comparison: 0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [49.07, 77.52]Cochran-Mantel-Haenszel
Comparison: 0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [42.28, 71.34]Cochran-Mantel-Haenszel
Comparison: 0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [53.58, 81.55]Cochran-Mantel-Haenszel
Comparison: 0.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [38.62, 67.99]Cochran-Mantel-Haenszel
Comparison: 0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.1495% CI: [-3.26, 23.82]Cochran-Mantel-Haenszel
Comparison: 0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.67495% CI: [-10.94, 16.89]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [54.47, 85.48]Cochran-Mantel-Haenszel
Comparison: 0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.03495% CI: [1.22, 27.93]Cochran-Mantel-Haenszel
Comparison: 1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [58.25, 86.39]Cochran-Mantel-Haenszel
Comparison: 1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [52.63, 81.78]Cochran-Mantel-Haenszel
Comparison: 1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [58.4, 86.4]Cochran-Mantel-Haenszel
Comparison: 1 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [49.32, 78.91]Cochran-Mantel-Haenszel
Comparison: 1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.11995% CI: [-2.06, 18.85]Cochran-Mantel-Haenszel
Comparison: 1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.61695% CI: [-8.3, 13.98]Cochran-Mantel-Haenszel
Comparison: 1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.12595% CI: [-2.2, 18.87]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [60.73, 88.25]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [55.05, 83.71]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [59.65, 87.38]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [54.01, 82.71]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.18795% CI: [-2.99, 15.65]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.88195% CI: [-9.42, 10.99]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.31195% CI: [-4.6, 14.71]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [55.82, 86.38]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [52.88, 83.74]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.26595% CI: [-3.92, 14.41]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.7195% CI: [-7.82, 11.53]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.41695% CI: [-5.52, 13.49]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [55.82, 86.38]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [52.88, 83.74]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [54.47, 85.48]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [50.16, 81.74]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.26595% CI: [-3.92, 14.41]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.7195% CI: [-7.82, 11.53]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.41695% CI: [-5.52, 13.49]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [55.82, 86.38]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [52.88, 83.74]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [54.47, 85.48]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [50.16, 81.74]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.26595% CI: [-3.92, 14.41]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.7195% CI: [-7.82, 11.53]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.41695% CI: [-5.52, 13.49]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [55.82, 86.38]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [52.88, 83.74]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [54.47, 85.48]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [50.16, 81.74]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.26595% CI: [-3.92, 14.41]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.7195% CI: [-7.82, 11.53]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.41695% CI: [-5.52, 13.49]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [55.82, 86.38]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [52.88, 83.74]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [54.47, 85.48]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [50.16, 81.74]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.26595% CI: [-3.92, 14.41]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.7195% CI: [-7.82, 11.53]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.41695% CI: [-5.52, 13.49]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [55.82, 86.38]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [52.88, 83.74]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [54.47, 85.48]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [50.16, 81.74]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.26595% CI: [-3.92, 14.41]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.7195% CI: [-7.82, 11.53]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.41695% CI: [-5.52, 13.49]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [55.82, 86.38]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [52.88, 83.74]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [54.47, 85.48]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [50.16, 81.74]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.26595% CI: [-3.92, 14.41]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.7195% CI: [-7.82, 11.53]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.41695% CI: [-5.52, 13.49]Cochran-Mantel-Haenszel
Comparison: 9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [55.82, 86.38]Cochran-Mantel-Haenszel
Comparison: 9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [52.88, 83.74]Cochran-Mantel-Haenszel
Comparison: 9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [54.47, 85.48]Cochran-Mantel-Haenszel
Comparison: 9 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [50.16, 81.74]Cochran-Mantel-Haenszel
Comparison: 9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.26595% CI: [-3.92, 14.41]Cochran-Mantel-Haenszel
Comparison: 9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.7195% CI: [-7.82, 11.53]Cochran-Mantel-Haenszel
Comparison: 9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.41695% CI: [-5.52, 13.49]Cochran-Mantel-Haenszel
Comparison: 10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [55.82, 86.38]Cochran-Mantel-Haenszel
Comparison: 10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [52.88, 83.74]Cochran-Mantel-Haenszel
Comparison: 10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [54.47, 85.48]Cochran-Mantel-Haenszel
Comparison: 10 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [50.16, 81.74]Cochran-Mantel-Haenszel
Comparison: 10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.26595% CI: [-3.92, 14.41]Cochran-Mantel-Haenszel
Comparison: 10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.7195% CI: [-7.82, 11.53]Cochran-Mantel-Haenszel
Comparison: 10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.41695% CI: [-5.52, 13.49]Cochran-Mantel-Haenszel
Comparison: 11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [55.82, 86.38]Cochran-Mantel-Haenszel
Comparison: 11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [52.88, 83.74]Cochran-Mantel-Haenszel
Comparison: 11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [54.47, 85.48]Cochran-Mantel-Haenszel
Comparison: 11 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [50.16, 81.74]Cochran-Mantel-Haenszel
Comparison: 11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.26595% CI: [-3.92, 14.41]Cochran-Mantel-Haenszel
Comparison: 11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.7195% CI: [-7.82, 11.53]Cochran-Mantel-Haenszel
Comparison: 11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.41695% CI: [-5.52, 13.49]Cochran-Mantel-Haenszel
Comparison: 12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [55.82, 86.38]Cochran-Mantel-Haenszel
Comparison: 12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [52.88, 83.74]Cochran-Mantel-Haenszel
Comparison: 12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [54.47, 85.48]Cochran-Mantel-Haenszel
Comparison: 12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [50.16, 81.74]Cochran-Mantel-Haenszel
Comparison: 12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.26595% CI: [-3.92, 14.41]Cochran-Mantel-Haenszel
Comparison: 12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.7195% CI: [-7.82, 11.53]Cochran-Mantel-Haenszel
Comparison: 12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.41695% CI: [-5.52, 13.49]Cochran-Mantel-Haenszel
Secondary
Cumulative Percentage of Participants With Meaningful Relief
Percentage of participants with meaningful relief was reported. Participants evaluated time to meaningful relief by stopping a second stopwatch labeled meaningful relief at the moment they first began to experience meaningful relief. Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch. Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.
Time frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 12 hours | 20.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 1.5 hours | 6.7 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 0.25 hours | 0.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 4 hours | 13.3 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 11 hours | 20.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 0.5 hours | 0.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 2 hours | 10.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 5 hours | 13.3 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 3 hours | 10.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 1 hour | 3.3 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 7 hours | 16.7 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 9 hours | 16.7 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 6 hours | 16.7 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 10 hours | 20.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 8 hours | 16.7 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 0.5 hours | 33.3 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 7 hours | 91.1 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 12 hours | 91.1 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 8 hours | 91.1 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 9 hours | 91.1 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 1 hour | 65.6 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 0.25 hours | 1.1 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 1.5 hours | 81.1 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 2 hours | 85.6 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 11 hours | 91.1 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 3 hours | 90.0 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 4 hours | 90.0 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 5 hours | 91.1 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 10 hours | 91.1 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 6 hours | 91.1 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 0.25 hours | 1.1 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 1.5 hours | 69.9 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 9 hours | 88.2 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 4 hours | 83.9 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 1 hour | 54.8 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 10 hours | 88.2 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 8 hours | 88.2 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 7 hours | 87.1 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 5 hours | 84.9 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 12 hours | 88.2 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 0.5 hours | 23.7 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 2 hours | 77.4 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 6 hours | 86.0 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 3 hours | 81.7 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 11 hours | 88.2 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 12 hours | 89.9 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 0.25 hours | 3.4 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 0.5 hours | 22.5 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 1 hour | 67.4 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 1.5 hours | 77.5 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 2 hours | 84.3 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 3 hours | 88.8 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 4 hours | 89.9 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 5 hours | 89.9 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 6 hours | 89.9 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 7 hours | 89.9 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 8 hours | 89.9 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 9 hours | 89.9 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 10 hours | 89.9 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 11 hours | 89.9 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Meaningful Relief | 9 hours | 85.9 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Meaningful Relief | 6 hours | 83.7 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Meaningful Relief | 5 hours | 82.6 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Meaningful Relief | 4 hours | 81.5 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Meaningful Relief | 0.25 hours | 1.1 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Meaningful Relief | 10 hours | 85.9 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Meaningful Relief | 3 hours | 80.4 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Meaningful Relief | 2 hours | 73.9 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Meaningful Relief | 1.5 hours | 66.3 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Meaningful Relief | 12 hours | 85.9 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Meaningful Relief | 11 hours | 85.9 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Meaningful Relief | 1 hour | 54.3 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Meaningful Relief | 8 hours | 85.9 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Meaningful Relief | 7 hours | 84.8 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Meaningful Relief | 0.5 hours | 13.0 percentage of participants |
Comparison: 0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and its associated 95% CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.p-value: 0.57195% CI: [-1.04, 3.2]Cochran-Mantel-Haenszel
Comparison: 0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.59395% CI: [-0.94, 2.9]Cochran-Mantel-Haenszel
Comparison: 0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.28295% CI: [-0.39, 7.68]Cochran-Mantel-Haenszel
Comparison: 0.25 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.55295% CI: [-1.11, 3.42]Cochran-Mantel-Haenszel
Comparison: 0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.99495% CI: [-3.13, 3.11]Cochran-Mantel-Haenszel
Comparison: 0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.87995% CI: [-3.26, 2.8]Cochran-Mantel-Haenszel
Comparison: 0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.2895% CI: [-1.98, 6.64]Cochran-Mantel-Haenszel
Comparison: 0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [24.54, 42.81]Cochran-Mantel-Haenszel
Comparison: 0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.00395% CI: [14.93, 31.75]Cochran-Mantel-Haenszel
Comparison: 0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.00595% CI: [13.55, 31]Cochran-Mantel-Haenszel
Comparison: 0.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.03595% CI: [6.28, 20.5]Cochran-Mantel-Haenszel
Comparison: 0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.00195% CI: [8.67, 31.62]Cochran-Mantel-Haenszel
Comparison: 0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.08895% CI: [-1.39, 20.51]Cochran-Mantel-Haenszel
Comparison: 0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.195% CI: [-1.73, 20.45]Cochran-Mantel-Haenszel
Comparison: 1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [50.93, 74.15]Cochran-Mantel-Haenszel
Comparison: 1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [39.5, 63.82]Cochran-Mantel-Haenszel
Comparison: 1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [52.92, 76.43]Cochran-Mantel-Haenszel
Comparison: 1 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [40.43, 63.63]Cochran-Mantel-Haenszel
Comparison: 1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.13895% CI: [-3.04, 24.35]Cochran-Mantel-Haenszel
Comparison: 1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.93595% CI: [-14.71, 13.52]Cochran-Mantel-Haenszel
Comparison: 1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.06395% CI: [-0.57, 27.17]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [62.82, 86.53]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [50.42, 75.95]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [59.21, 83.57]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [47.89, 73.11]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.02795% CI: [1.97, 26.89]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.72995% CI: [-10.91, 15.61]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.08795% CI: [-1.55, 24.21]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [62.5, 88.7]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [53.65, 81.24]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [61.21, 87.7]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [50.3, 78.17]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.05295% CI: [0.12, 23.06]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.65295% CI: [-9.49, 15.16]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.0995% CI: [-1.47, 22.03]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [67.41, 92.46]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [58.25, 85.05]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [66.29, 91.56]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [57.04, 84.07]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.06995% CI: [-0.59, 19.8]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.91195% CI: [-10.73, 12.03]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.12795% CI: [-2.23, 18.77]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [62.37, 90.72]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [55.93, 85.28]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [62.22, 90.79]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [53.02, 83.09]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.09895% CI: [-1.47, 18.61]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.72195% CI: [-9.02, 13.04]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.11595% CI: [-1.85, 18.41]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [63.63, 91.69]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [57.07, 86.22]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [62.22, 90.79]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [54.14, 84.06]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.08695% CI: [-1.15, 18.27]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.71495% CI: [-8.76, 12.77]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.16495% CI: [-2.8, 17.22]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [59.56, 89.2]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [54.29, 84.7]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [58.18, 88.3]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [51.4, 82.61]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.12995% CI: [-2.12, 17.04]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.71295% CI: [-8.5, 12.43]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.22995% CI: [-3.76, 16]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [59.56, 89.2]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [55.45, 85.64]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [58.18, 88.3]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [52.53, 83.57]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.18695% CI: [-3.05, 15.81]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.70395% CI: [-8.18, 12.12]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.31295% CI: [-4.68, 14.79]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [59.56, 89.2]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [56.61, 86.57]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [58.18, 88.3]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [53.86, 84.56]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.26595% CI: [-3.92, 14.41]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.7195% CI: [-7.82, 11.53]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.41695% CI: [-5.52, 13.49]Cochran-Mantel-Haenszel
Comparison: 9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [59.56, 89.2]Cochran-Mantel-Haenszel
Comparison: 9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [56.61, 86.57]Cochran-Mantel-Haenszel
Comparison: 9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [58.18, 88.3]Cochran-Mantel-Haenszel
Comparison: 9 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [53.86, 84.56]Cochran-Mantel-Haenszel
Comparison: 9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.26595% CI: [-3.92, 14.41]Cochran-Mantel-Haenszel
Comparison: 9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.7195% CI: [-7.82, 11.53]Cochran-Mantel-Haenszel
Comparison: 9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.41695% CI: [-5.52, 13.49]Cochran-Mantel-Haenszel
Comparison: 10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [55.82, 86.38]Cochran-Mantel-Haenszel
Comparison: 10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [52.88, 83.74]Cochran-Mantel-Haenszel
Comparison: 10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [54.47, 85.48]Cochran-Mantel-Haenszel
Comparison: 10 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [50.16, 81.74]Cochran-Mantel-Haenszel
Comparison: 10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.26595% CI: [-3.92, 14.41]Cochran-Mantel-Haenszel
Comparison: 10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.7195% CI: [-7.82, 11.53]Cochran-Mantel-Haenszel
Comparison: 10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.41695% CI: [-5.52, 13.49]Cochran-Mantel-Haenszel
Comparison: 11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [55.82, 86.38]Cochran-Mantel-Haenszel
Comparison: 11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [52.88, 83.74]Cochran-Mantel-Haenszel
Comparison: 11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [54.47, 85.48]Cochran-Mantel-Haenszel
Comparison: 11 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [50.16, 81.74]Cochran-Mantel-Haenszel
Comparison: 11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.26595% CI: [-3.92, 14.41]Cochran-Mantel-Haenszel
Comparison: 11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.7195% CI: [-7.82, 11.53]Cochran-Mantel-Haenszel
Comparison: 11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.41695% CI: [-5.52, 13.49]Cochran-Mantel-Haenszel
Comparison: 12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [55.82, 86.38]Cochran-Mantel-Haenszel
Comparison: 12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [52.88, 83.74]Cochran-Mantel-Haenszel
Comparison: 12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [54.47, 85.48]Cochran-Mantel-Haenszel
Comparison: 12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [50.16, 81.74]Cochran-Mantel-Haenszel
Comparison: 12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.26595% CI: [-3.92, 14.41]Cochran-Mantel-Haenszel
Comparison: 12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.7195% CI: [-7.82, 11.53]Cochran-Mantel-Haenszel
Comparison: 12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.41695% CI: [-5.52, 13.49]Cochran-Mantel-Haenszel
Secondary
Cumulative Percentage of Participants With Treatment Failure
Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first. Percentage of participants who had treatment failure were reported.
Time frame: 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 5 hour | 80.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 8 hour | 80.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 6 hour | 80.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 12 hour | 80.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 2 hour | 73.3 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 7 hour | 80.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 11 hour | 80.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 3 hour | 80.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 1.5 hour | 43.3 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 10 hour | 80.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 4 hour | 80.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 9 hour | 80.0 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 5 hour | 4.4 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 4 hour | 3.3 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 8 hour | 28.9 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 7 hour | 17.8 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 3 hour | 2.2 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 6 hour | 8.9 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 12 hour | 64.4 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 1.5 hour | 2.2 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 10 hour | 51.1 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 2 hour | 2.2 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 9 hour | 40.0 percentage of participants |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 11 hour | 57.8 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 11 hour | 53.8 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 1.5 hour | 2.2 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 2 hour | 6.5 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 3 hour | 8.6 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 4 hour | 9.7 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 5 hour | 14.0 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 7 hour | 20.4 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 8 hour | 23.7 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 9 hour | 33.3 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 10 hour | 46.2 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 6 hour | 18.3 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 12 hour | 57.0 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 5 hour | 10.1 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 8 hour | 25.8 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 4 hour | 7.9 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 1.5 hour | 4.5 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 9 hour | 36.0 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 3 hour | 6.7 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 10 hour | 42.7 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 2 hour | 5.6 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 12 hour | 50.6 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 11 hour | 48.3 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 6 hour | 14.6 percentage of participants |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 7 hour | 15.7 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Treatment Failure | 7 hour | 27.2 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Treatment Failure | 1.5 hour | 5.4 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Treatment Failure | 10 hour | 45.7 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Treatment Failure | 8 hour | 32.6 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Treatment Failure | 4 hour | 15.2 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Treatment Failure | 2 hour | 10.9 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Treatment Failure | 6 hour | 20.7 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Treatment Failure | 5 hour | 15.2 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Treatment Failure | 9 hour | 35.9 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Treatment Failure | 3 hour | 13.0 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Treatment Failure | 11 hour | 53.3 percentage of participants |
| Ibuprofen 400 mg | Cumulative Percentage of Participants With Treatment Failure | 12 hour | 55.4 percentage of participants |
Comparison: 1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-59.56, -22.58]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-59.41, -22.56]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-57.49, -19.79]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-56.94, -19.28]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.27495% CI: [-8.67, 2.4]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.30495% CI: [-8.4, 2.62]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.76995% CI: [-7.41, 5.49]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-88, -54.38]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-84.26, -49.72]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-84.75, -50.19]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-80.45, -45.07]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.02195% CI: [-15.55, -1.5]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.33795% CI: [-12.05, 4.07]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.20495% CI: [-13.28, 2.76]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-92.29, -63.49]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-86.71, -56.58]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-88.06, -57.68]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-82.87, -51.52]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.00795% CI: [-18.2, -3.21]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.38595% CI: [-12.86, 4.88]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.16295% CI: [-14.97, 2.4]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-91.35, -62.27]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-85.79, -55.41]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-87, -56.31]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-81.03, -49.34]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.00795% CI: [-19.86, -3.55]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.3195% CI: [-14.34, 4.46]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.12695% CI: [-16.63, 1.9]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-90.35, -60.93]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-81.99, -50.88]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-84.96, -53.71]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-81.03, -49.34]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.01695% CI: [-19.02, -2.19]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.89595% CI: [-10.69, 9.32]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.30895% CI: [-14.8, 4.62]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-86.58, -56.13]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-78.04, -46.19]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-80.64, -48.5]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-76.12, -43.55]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.02895% CI: [-21.63, -1.35]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.74795% CI: [-13.15, 9.38]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.30395% CI: [-16.88, 5.12]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-78.64, -46.34]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-76.15, -44.02]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-79.64, -47.27]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-70.1, -36.72]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.13795% CI: [-21.18, 2.9]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.31195% CI: [-18.39, 5.71]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.06795% CI: [-22.97, 0.52]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-68.42, -34.66]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-73.27, -40.76]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-70.16, -36.26]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-64.81, -30.83]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.60495% CI: [-16.89, 9.85]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.18495% CI: [-21.5, 3.94]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.3495% CI: [-19.56, 6.7]Cochran-Mantel-Haenszel
Comparison: 9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-57.67, -22.88]Cochran-Mantel-Haenszel
Comparison: 9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-64.21, -30.27]Cochran-Mantel-Haenszel
Comparison: 9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-60.57, -25.72]Cochran-Mantel-Haenszel
Comparison: 9 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-61.55, -27.34]Cochran-Mantel-Haenszel
Comparison: 9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.54895% CI: [-9.8, 18.38]Cochran-Mantel-Haenszel
Comparison: 9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.72195% CI: [-16.2, 11.18]Cochran-Mantel-Haenszel
Comparison: 9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.95195% CI: [-13.47, 14.35]Cochran-Mantel-Haenszel
Comparison: 10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.00595% CI: [-46.66, -11.59]Cochran-Mantel-Haenszel
Comparison: 10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.00195% CI: [-51.62, -16.97]Cochran-Mantel-Haenszel
Comparison: 10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-53.8, -18.73]Cochran-Mantel-Haenszel
Comparison: 10 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-51.77, -17.35]Cochran-Mantel-Haenszel
Comparison: 10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.45595% CI: [-8.89, 19.79]Cochran-Mantel-Haenszel
Comparison: 10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.95395% CI: [-13.8, 14.65]Cochran-Mantel-Haenszel
Comparison: 10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.73195% CI: [-16.63, 11.66]Cochran-Mantel-Haenszel
Comparison: 11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.02495% CI: [-39.97, -5.29]Cochran-Mantel-Haenszel
Comparison: 11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.00995% CI: [-44.12, -9.62]Cochran-Mantel-Haenszel
Comparison: 11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.00395% CI: [-48.36, -13.16]Cochran-Mantel-Haenszel
Comparison: 11 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.00795% CI: [-44.51, -10]Cochran-Mantel-Haenszel
Comparison: 11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.51695% CI: [-9.5, 18.82]Cochran-Mantel-Haenszel
Comparison: 11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.93995% CI: [-13.63, 14.72]Cochran-Mantel-Haenszel
Comparison: 11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.53695% CI: [-18.86, 9.8]Cochran-Mantel-Haenszel
Comparison: 12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.10795% CI: [-33.02, 1.41]Cochran-Mantel-Haenszel
Comparison: 12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.01995% CI: [-40.91, -6.51]Cochran-Mantel-Haenszel
Comparison: 12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.00695% CI: [-45.99, -10.88]Cochran-Mantel-Haenszel
Comparison: 12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.01295% CI: [-42.23, -7.85]Cochran-Mantel-Haenszel
Comparison: 12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.19595% CI: [-4.75, 23.08]Cochran-Mantel-Haenszel
Comparison: 12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.83595% CI: [-12.54, 15.5]Cochran-Mantel-Haenszel
Comparison: 12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.54295% CI: [-18.61, 9.79]Cochran-Mantel-Haenszel
Secondary
Pain Intensity Difference on 11-Point Numerical Scale (PID11)
PID11: baseline pain severity score minus pain severity score at a given time point. Pain intensity was assessed on an 11-point numerical pain severity rating scale. PID11 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID11: -5 (worst score) to 10 (best score).
Time frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 4 hour | 0.3 units on a scale | Standard Deviation 2.5 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 3 hour | 0.1 units on a scale | Standard Deviation 2.2 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 2 hour | -0.1 units on a scale | Standard Deviation 1.8 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 1 hour | 0.1 units on a scale | Standard Deviation 1.4 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 8 hour | 0.3 units on a scale | Standard Deviation 2.6 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 1.5 hour | 0.0 units on a scale | Standard Deviation 1.7 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 7 hour | 0.3 units on a scale | Standard Deviation 2.5 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 10 hour | 0.6 units on a scale | Standard Deviation 3 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 0.5 hour | 0.2 units on a scale | Standard Deviation 1.1 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 12 hour | 0.7 units on a scale | Standard Deviation 3.2 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 0.25 hour | 0.1 units on a scale | Standard Deviation 0.6 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 11 hour | 0.6 units on a scale | Standard Deviation 2.9 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 6 hour | 0.4 units on a scale | Standard Deviation 2.6 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 5 hour | 0.2 units on a scale | Standard Deviation 2.4 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 9 hour | 0.5 units on a scale | Standard Deviation 2.8 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 6 hour | 4.6 units on a scale | Standard Deviation 2.9 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 1.5 hour | 5.3 units on a scale | Standard Deviation 2.4 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 10 hour | 1.9 units on a scale | Standard Deviation 2.8 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 0.25 hour | 1.0 units on a scale | Standard Deviation 1.6 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 0.5 hour | 3.0 units on a scale | Standard Deviation 2.3 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 1 hour | 4.7 units on a scale | Standard Deviation 2.5 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 2 hour | 5.5 units on a scale | Standard Deviation 2.5 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 3 hour | 5.7 units on a scale | Standard Deviation 2.5 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 4 hour | 5.5 units on a scale | Standard Deviation 2.5 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 5 hour | 5.3 units on a scale | Standard Deviation 2.6 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 7 hour | 3.9 units on a scale | Standard Deviation 2.9 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 8 hour | 3.1 units on a scale | Standard Deviation 3 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 9 hour | 2.5 units on a scale | Standard Deviation 3 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 11 hour | 1.6 units on a scale | Standard Deviation 2.8 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 12 hour | 1.1 units on a scale | Standard Deviation 2.4 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 0.25 hour | 0.8 units on a scale | Standard Deviation 1.3 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 10 hour | 2.1 units on a scale | Standard Deviation 3 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 6 hour | 4.8 units on a scale | Standard Deviation 3.3 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 0.5 hour | 2.5 units on a scale | Standard Deviation 2.3 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 9 hour | 2.7 units on a scale | Standard Deviation 3.1 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 11 hour | 1.7 units on a scale | Standard Deviation 2.9 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 12 hour | 1.5 units on a scale | Standard Deviation 2.6 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 8 hour | 3.5 units on a scale | Standard Deviation 3.2 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 7 hour | 4.2 units on a scale | Standard Deviation 3.2 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 1.5 hour | 5.0 units on a scale | Standard Deviation 2.8 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 3 hour | 5.5 units on a scale | Standard Deviation 3 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 2 hour | 5.3 units on a scale | Standard Deviation 3 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 5 hour | 5.1 units on a scale | Standard Deviation 3.2 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 4 hour | 5.4 units on a scale | Standard Deviation 3.1 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 1 hour | 4.2 units on a scale | Standard Deviation 2.6 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 0.25 hour | 0.9 units on a scale | Standard Deviation 1.6 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 0.5 hour | 2.6 units on a scale | Standard Deviation 2.3 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 12 hour | 1.7 units on a scale | Standard Deviation 2.5 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 3 hour | 5.7 units on a scale | Standard Deviation 2.7 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 2 hour | 5.6 units on a scale | Standard Deviation 2.5 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 11 hour | 2.0 units on a scale | Standard Deviation 2.6 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 5 hour | 5.3 units on a scale | Standard Deviation 3 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 6 hour | 5.0 units on a scale | Standard Deviation 3.1 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 7 hour | 4.2 units on a scale | Standard Deviation 3.1 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 8 hour | 3.2 units on a scale | Standard Deviation 3 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 4 hour | 5.6 units on a scale | Standard Deviation 2.7 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 9 hour | 2.8 units on a scale | Standard Deviation 3 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 10 hour | 2.5 units on a scale | Standard Deviation 2.9 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 1 hour | 4.5 units on a scale | Standard Deviation 2.4 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 1.5 hour | 5.3 units on a scale | Standard Deviation 2.4 |
| Ibuprofen 400 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 6 hour | 4.4 units on a scale | Standard Deviation 3.2 |
| Ibuprofen 400 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 1.5 hour | 4.6 units on a scale | Standard Deviation 2.7 |
| Ibuprofen 400 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 9 hour | 2.9 units on a scale | Standard Deviation 3 |
| Ibuprofen 400 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 0.25 hour | 0.4 units on a scale | Standard Deviation 1 |
| Ibuprofen 400 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 0.5 hour | 1.7 units on a scale | Standard Deviation 1.8 |
| Ibuprofen 400 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 10 hour | 2.5 units on a scale | Standard Deviation 3 |
| Ibuprofen 400 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 3 hour | 5.2 units on a scale | Standard Deviation 2.9 |
| Ibuprofen 400 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 1 hour | 3.8 units on a scale | Standard Deviation 2.6 |
| Ibuprofen 400 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 5 hour | 4.9 units on a scale | Standard Deviation 3 |
| Ibuprofen 400 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 12 hour | 1.9 units on a scale | Standard Deviation 2.6 |
| Ibuprofen 400 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 7 hour | 3.9 units on a scale | Standard Deviation 3.2 |
| Ibuprofen 400 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 4 hour | 5.1 units on a scale | Standard Deviation 3 |
| Ibuprofen 400 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 8 hour | 3.5 units on a scale | Standard Deviation 3.2 |
| Ibuprofen 400 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 2 hour | 5.0 units on a scale | Standard Deviation 2.8 |
| Ibuprofen 400 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 11 hour | 2.2 units on a scale | Standard Deviation 2.9 |
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00695% CI: [0.25, 1.51]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.0395% CI: [0.07, 1.31]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.01295% CI: [0.17, 1.44]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.23795% CI: [-0.25, 1.01]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.02495% CI: [0.07, 0.93]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.1595% CI: [-0.11, 0.73]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.05495% CI: [-0.01, 0.86]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.92, 3.85]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.56, 3.47]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.54, 3.47]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.79, 2.72]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.47, 1.79]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.02195% CI: [0.11, 1.41]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.02795% CI: [0.09, 1.41]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [3.65, 5.84]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [3.13, 5.29]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [3.37, 5.56]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.83, 5.02]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.03195% CI: [0.08, 1.58]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.44295% CI: [-0.44, 1.02]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.15295% CI: [-0.2, 1.3]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [4.52, 6.72]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [3.96, 6.13]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [4.3, 6.5]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [3.78, 5.98]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.05595% CI: [-0.01, 1.49]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.66695% CI: [-0.57, 0.9]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.18195% CI: [-0.24, 1.27]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [4.71, 7.01]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [4.29, 6.57]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [4.64, 6.94]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [4.19, 6.5]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.295% CI: [-0.27, 1.31]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.83195% CI: [-0.69, 0.85]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.26895% CI: [-0.34, 1.24]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [4.54, 6.91]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [4.13, 6.48]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [4.41, 6.78]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [4.17, 6.54]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.36795% CI: [-0.44, 1.19]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.90895% CI: [-0.84, 0.75]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.55395% CI: [-0.57, 1.06]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [4.22, 6.68]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [3.88, 6.31]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [4.19, 6.66]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [3.94, 6.4]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.51895% CI: [-0.57, 1.12]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.8695% CI: [-0.9, 0.75]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.55695% CI: [-0.59, 1.1]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [4.17, 6.71]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [3.68, 6.19]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [4, 6.54]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [3.79, 6.34]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.39295% CI: [-0.49, 1.25]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.76295% CI: [-0.98, 0.72]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.63895% CI: [-0.66, 1.08]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [3.2, 5.9]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [3.11, 5.78]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [3.56, 6.26]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [3.04, 5.74]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.74195% CI: [-0.77, 1.08]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.90795% CI: [-0.85, 0.95]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.27495% CI: [-0.41, 1.44]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.4, 5.13]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.56, 5.26]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.75, 5.48]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.64, 5.38]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.60795% CI: [-1.18, 0.69]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.82495% CI: [-1.02, 0.81]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.82795% CI: [-0.83, 1.04]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.58, 4.39]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.88, 4.65]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.71, 4.52]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.16, 4.98]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.23295% CI: [-1.55, 0.38]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.52295% CI: [-1.24, 0.63]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.35695% CI: [-1.41, 0.51]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00195% CI: [0.92, 3.69]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.08, 3.82]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.31, 4.08]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.46, 4.23]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.26495% CI: [-1.49, 0.41]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.495% CI: [-1.32, 0.53]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.75895% CI: [-1.1, 0.8]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.01895% CI: [0.27, 2.97]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00695% CI: [0.55, 3.21]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.94, 3.63]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.05, 3.75]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.09795% CI: [-1.7, 0.14]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.25495% CI: [-1.42, 0.38]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.81295% CI: [-1.03, 0.81]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.04595% CI: [0.03, 2.61]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.01595% CI: [0.31, 2.87]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00995% CI: [0.43, 3.02]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00295% CI: [0.78, 3.37]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.09495% CI: [-1.64, 0.13]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.26995% CI: [-1.35, 0.38]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.43795% CI: [-1.23, 0.53]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.21895% CI: [-0.44, 1.92]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.04695% CI: [0.02, 2.35]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.0395% CI: [0.13, 2.49]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00495% CI: [0.57, 2.93]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.01495% CI: [-1.82, -0.2]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.1695% CI: [-1.35, 0.22]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.28495% CI: [-1.25, 0.37]ANOVA
Secondary
Pain Intensity Difference on 4-Point Categorical Scale (PID4)
PID4: baseline pain severity score minus pain severity score at a given time point. Pain intensity was assessed on a 4-point categorical pain severity rating scale. PID4 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 \[no pain\] to 3 \[worst possible pain\]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID4: -1 (worst score) to 3 (best score).
Time frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 3 hour | 0.1 units on a scale | Standard Deviation 0.8 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 2 hour | 0.0 units on a scale | Standard Deviation 0.7 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 1.5 hour | 0.1 units on a scale | Standard Deviation 0.7 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 11 hour | 0.2 units on a scale | Standard Deviation 1 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 0.25 hour | 0.1 units on a scale | Standard Deviation 0.3 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 10 hour | 0.2 units on a scale | Standard Deviation 1 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 9 hour | 0.2 units on a scale | Standard Deviation 0.9 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 8 hour | 0.2 units on a scale | Standard Deviation 0.9 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 0.5 hour | 0.1 units on a scale | Standard Deviation 0.4 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 12 hour | 0.3 units on a scale | Standard Deviation 1.1 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 7 hour | 0.2 units on a scale | Standard Deviation 0.9 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 6 hour | 0.2 units on a scale | Standard Deviation 0.9 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 5 hour | 0.1 units on a scale | Standard Deviation 0.9 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 1 hour | 0.1 units on a scale | Standard Deviation 0.6 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 4 hour | 0.1 units on a scale | Standard Deviation 0.9 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 3 hour | 1.7 units on a scale | Standard Deviation 0.9 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 1 hour | 1.5 units on a scale | Standard Deviation 0.9 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 0.5 hour | 0.9 units on a scale | Standard Deviation 0.8 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 1.5 hour | 1.6 units on a scale | Standard Deviation 0.8 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 2 hour | 1.7 units on a scale | Standard Deviation 0.9 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 0.25 hour | 0.3 units on a scale | Standard Deviation 0.6 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 4 hour | 1.7 units on a scale | Standard Deviation 0.9 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 5 hour | 1.6 units on a scale | Standard Deviation 0.9 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 6 hour | 1.4 units on a scale | Standard Deviation 1 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 7 hour | 1.2 units on a scale | Standard Deviation 1 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 8 hour | 0.9 units on a scale | Standard Deviation 1 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 9 hour | 0.8 units on a scale | Standard Deviation 1 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 10 hour | 0.6 units on a scale | Standard Deviation 0.9 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 11 hour | 0.5 units on a scale | Standard Deviation 1 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 12 hour | 0.3 units on a scale | Standard Deviation 0.8 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 3 hour | 1.6 units on a scale | Standard Deviation 1 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 1 hour | 1.2 units on a scale | Standard Deviation 0.8 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 4 hour | 1.6 units on a scale | Standard Deviation 1.1 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 11 hour | 0.5 units on a scale | Standard Deviation 0.9 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 5 hour | 1.5 units on a scale | Standard Deviation 1.1 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 6 hour | 1.4 units on a scale | Standard Deviation 1.1 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 0.5 hour | 0.7 units on a scale | Standard Deviation 0.8 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 7 hour | 1.2 units on a scale | Standard Deviation 1.1 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 8 hour | 1.0 units on a scale | Standard Deviation 1 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 9 hour | 0.7 units on a scale | Standard Deviation 1 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 0.25 hour | 0.2 units on a scale | Standard Deviation 0.4 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 12 hour | 0.4 units on a scale | Standard Deviation 0.8 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 10 hour | 0.6 units on a scale | Standard Deviation 0.9 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 1.5 hour | 1.5 units on a scale | Standard Deviation 1 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 2 hour | 1.6 units on a scale | Standard Deviation 1 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 6 hour | 1.6 units on a scale | Standard Deviation 1.1 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 7 hour | 1.3 units on a scale | Standard Deviation 1.1 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 8 hour | 1.0 units on a scale | Standard Deviation 1 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 0.25 hour | 0.3 units on a scale | Standard Deviation 0.6 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 3 hour | 1.7 units on a scale | Standard Deviation 1 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 9 hour | 0.8 units on a scale | Standard Deviation 0.9 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 2 hour | 1.7 units on a scale | Standard Deviation 0.9 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 12 hour | 0.4 units on a scale | Standard Deviation 0.8 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 4 hour | 1.7 units on a scale | Standard Deviation 0.9 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 1 hour | 1.4 units on a scale | Standard Deviation 0.9 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 10 hour | 0.7 units on a scale | Standard Deviation 0.9 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 5 hour | 1.6 units on a scale | Standard Deviation 1 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 0.5 hour | 0.8 units on a scale | Standard Deviation 0.8 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 11 hour | 0.6 units on a scale | Standard Deviation 0.9 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 1.5 hour | 1.6 units on a scale | Standard Deviation 0.9 |
| Ibuprofen 400 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 9 hour | 0.8 units on a scale | Standard Deviation 1 |
| Ibuprofen 400 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 6 hour | 1.3 units on a scale | Standard Deviation 1 |
| Ibuprofen 400 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 1.5 hour | 1.4 units on a scale | Standard Deviation 0.9 |
| Ibuprofen 400 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 11 hour | 0.6 units on a scale | Standard Deviation 0.9 |
| Ibuprofen 400 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 3 hour | 1.6 units on a scale | Standard Deviation 1 |
| Ibuprofen 400 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 7 hour | 1.2 units on a scale | Standard Deviation 1 |
| Ibuprofen 400 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 0.25 hour | 0.2 units on a scale | Standard Deviation 0.4 |
| Ibuprofen 400 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 1 hour | 1.1 units on a scale | Standard Deviation 0.9 |
| Ibuprofen 400 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 10 hour | 0.7 units on a scale | Standard Deviation 1 |
| Ibuprofen 400 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 4 hour | 1.6 units on a scale | Standard Deviation 1 |
| Ibuprofen 400 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 8 hour | 1.0 units on a scale | Standard Deviation 1.1 |
| Ibuprofen 400 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 0.5 hour | 0.5 units on a scale | Standard Deviation 0.7 |
| Ibuprofen 400 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 12 hour | 0.5 units on a scale | Standard Deviation 0.8 |
| Ibuprofen 400 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 2 hour | 1.5 units on a scale | Standard Deviation 0.9 |
| Ibuprofen 400 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 5 hour | 1.5 units on a scale | Standard Deviation 1 |
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.03395% CI: [0.02, 0.42]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.22495% CI: [-0.08, 0.33]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.02495% CI: [0.03, 0.44]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.50195% CI: [-0.13, 0.27]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.03695% CI: [0.01, 0.29]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.43595% CI: [-0.08, 0.2]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.02395% CI: [0.02, 0.31]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.52, 1.12]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.37, 0.97]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.45, 1.04]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00395% CI: [0.16, 0.75]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.16, 0.58]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.03995% CI: [0.01, 0.42]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00695% CI: [0.08, 0.5]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.01, 1.65]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.85, 1.49]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.03, 1.67]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.72, 1.36]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.01195% CI: [0.07, 0.52]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.26795% CI: [-0.1, 0.35]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00795% CI: [0.09, 0.53]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.24, 1.89]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.06, 1.7]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.25, 1.9]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.02, 1.67]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.05695% CI: [-0.01, 0.45]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.75995% CI: [-0.19, 0.26]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.05195% CI: [0, 0.45]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.3, 1.98]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.18, 1.85]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.37, 2.05]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.19, 1.86]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.34295% CI: [-0.12, 0.35]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.94395% CI: [-0.24, 0.23]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.12695% CI: [-0.05, 0.42]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.27, 1.98]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.15, 1.86]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.29, 2]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.18, 1.89]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.45395% CI: [-0.15, 0.34]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.81695% CI: [-0.28, 0.22]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.38495% CI: [-0.14, 0.36]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.19, 1.91]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.1, 1.82]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.25, 1.97]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.1, 1.82]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.48395% CI: [-0.16, 0.34]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.99195% CI: [-0.25, 0.25]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.22895% CI: [-0.1, 0.41]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.1, 1.85]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.94, 1.69]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.15, 1.9]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.03, 1.78]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.58795% CI: [-0.19, 0.33]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.51795% CI: [-0.35, 0.17]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.3695% CI: [-0.14, 0.38]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.81, 1.6]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.78, 1.57]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.97, 1.76]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.77, 1.56]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.81195% CI: [-0.24, 0.31]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.97795% CI: [-0.27, 0.28]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.16495% CI: [-0.08, 0.47]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.63, 1.43]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.6, 1.4]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.75, 1.56]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.66, 1.46]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.84695% CI: [-0.31, 0.25]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.70295% CI: [-0.33, 0.23]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.49695% CI: [-0.18, 0.38]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.41, 1.22]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.4, 1.21]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.46, 1.26]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.52, 1.33]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.44195% CI: [-0.39, 0.17]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.40895% CI: [-0.4, 0.16]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.65295% CI: [-0.35, 0.22]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00395% CI: [0.21, 1.02]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00795% CI: [0.15, 0.95]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.29, 1.1]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.29, 1.1]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.56795% CI: [-0.36, 0.2]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.31595% CI: [-0.42, 0.14]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.99795% CI: [-0.28, 0.28]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.05695% CI: [-0.01, 0.77]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.04795% CI: [0.01, 0.78]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00595% CI: [0.17, 0.95]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00795% CI: [0.14, 0.92]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.27695% CI: [-0.42, 0.12]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.31895% CI: [-0.41, 0.13]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.84995% CI: [-0.25, 0.3]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.13895% CI: [-0.09, 0.66]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.11195% CI: [-0.07, 0.68]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.03195% CI: [0.04, 0.79]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.01195% CI: [0.11, 0.87]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.13595% CI: [-0.47, 0.06]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.17595% CI: [-0.44, 0.08]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.5995% CI: [-0.34, 0.19]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.40295% CI: [-0.2, 0.49]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.26195% CI: [-0.15, 0.54]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.13495% CI: [-0.08, 0.61]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.03195% CI: [0.03, 0.72]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.06195% CI: [-0.47, 0.01]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.13895% CI: [-0.42, 0.06]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.35395% CI: [-0.35, 0.13]ANOVA
Secondary
Pain Relief Rating Score (PRR)
Participants answered a question: how much relief do you have from your starting pain? on a 5-point categorical pain relief rating scale. Scale ranges from 0= no relief to 4= complete relief.
Time frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Pain Relief Rating Score (PRR) | 11 hour | 0.6 units on a scale | Standard Deviation 1.3 |
| Placebo | Pain Relief Rating Score (PRR) | 4 hour | 0.5 units on a scale | Standard Deviation 1.1 |
| Placebo | Pain Relief Rating Score (PRR) | 3 hour | 0.5 units on a scale | Standard Deviation 1 |
| Placebo | Pain Relief Rating Score (PRR) | 2 hour | 0.4 units on a scale | Standard Deviation 0.8 |
| Placebo | Pain Relief Rating Score (PRR) | 1 hour | 0.4 units on a scale | Standard Deviation 0.6 |
| Placebo | Pain Relief Rating Score (PRR) | 9 hour | 0.6 units on a scale | Standard Deviation 1.2 |
| Placebo | Pain Relief Rating Score (PRR) | 1.5 hour | 0.4 units on a scale | Standard Deviation 0.8 |
| Placebo | Pain Relief Rating Score (PRR) | 8 hour | 0.6 units on a scale | Standard Deviation 1.2 |
| Placebo | Pain Relief Rating Score (PRR) | 7 hour | 0.6 units on a scale | Standard Deviation 1.2 |
| Placebo | Pain Relief Rating Score (PRR) | 0.25 hour | 0.2 units on a scale | Standard Deviation 0.4 |
| Placebo | Pain Relief Rating Score (PRR) | 10 hour | 0.6 units on a scale | Standard Deviation 1.2 |
| Placebo | Pain Relief Rating Score (PRR) | 12 hour | 0.6 units on a scale | Standard Deviation 1.3 |
| Placebo | Pain Relief Rating Score (PRR) | 6 hour | 0.6 units on a scale | Standard Deviation 1.2 |
| Placebo | Pain Relief Rating Score (PRR) | 5 hour | 0.5 units on a scale | Standard Deviation 1.1 |
| Placebo | Pain Relief Rating Score (PRR) | 0.5 hour | 0.3 units on a scale | Standard Deviation 0.5 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 6 hour | 2.5 units on a scale | Standard Deviation 1.3 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 12 hour | 0.8 units on a scale | Standard Deviation 1.3 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 3 hour | 2.9 units on a scale | Standard Deviation 1 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 4 hour | 2.9 units on a scale | Standard Deviation 1 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 0.25 hour | 0.6 units on a scale | Standard Deviation 0.8 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 0.5 hour | 1.7 units on a scale | Standard Deviation 1 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 1 hour | 2.5 units on a scale | Standard Deviation 1.1 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 1.5 hour | 2.8 units on a scale | Standard Deviation 0.9 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 2 hour | 2.9 units on a scale | Standard Deviation 1 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 5 hour | 2.7 units on a scale | Standard Deviation 1.1 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 7 hour | 2.1 units on a scale | Standard Deviation 1.4 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 8 hour | 1.7 units on a scale | Standard Deviation 1.5 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 9 hour | 1.4 units on a scale | Standard Deviation 1.5 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 10 hour | 1.2 units on a scale | Standard Deviation 1.4 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 11 hour | 0.9 units on a scale | Standard Deviation 1.4 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 1 hour | 2.3 units on a scale | Standard Deviation 1.1 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 0.25 hour | 0.5 units on a scale | Standard Deviation 0.8 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 4 hour | 2.7 units on a scale | Standard Deviation 1.3 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 0.5 hour | 1.5 units on a scale | Standard Deviation 1.2 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 8 hour | 1.9 units on a scale | Standard Deviation 1.4 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 11 hour | 1.0 units on a scale | Standard Deviation 1.3 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 7 hour | 2.2 units on a scale | Standard Deviation 1.4 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 2 hour | 2.7 units on a scale | Standard Deviation 1.2 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 6 hour | 2.4 units on a scale | Standard Deviation 1.4 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 10 hour | 1.2 units on a scale | Standard Deviation 1.3 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 3 hour | 2.8 units on a scale | Standard Deviation 1.2 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 12 hour | 0.9 units on a scale | Standard Deviation 1.2 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 5 hour | 2.6 units on a scale | Standard Deviation 1.3 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 1.5 hour | 2.6 units on a scale | Standard Deviation 1.1 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 9 hour | 1.5 units on a scale | Standard Deviation 1.4 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 8 hour | 1.9 units on a scale | Standard Deviation 1.5 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 2 hour | 2.9 units on a scale | Standard Deviation 1.1 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 0.5 hour | 1.6 units on a scale | Standard Deviation 1.1 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 3 hour | 3.0 units on a scale | Standard Deviation 1.2 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 4 hour | 2.9 units on a scale | Standard Deviation 1.2 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 5 hour | 2.8 units on a scale | Standard Deviation 1.3 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 0.25 hour | 0.7 units on a scale | Standard Deviation 0.9 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 6 hour | 2.7 units on a scale | Standard Deviation 1.4 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 7 hour | 2.3 units on a scale | Standard Deviation 1.4 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 11 hour | 1.3 units on a scale | Standard Deviation 1.4 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 9 hour | 1.7 units on a scale | Standard Deviation 1.5 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 12 hour | 1.1 units on a scale | Standard Deviation 1.3 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 1 hour | 2.5 units on a scale | Standard Deviation 1.2 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 10 hour | 1.5 units on a scale | Standard Deviation 1.5 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Pain Relief Rating Score (PRR) | 1.5 hour | 2.8 units on a scale | Standard Deviation 1 |
| Ibuprofen 400 mg | Pain Relief Rating Score (PRR) | 3 hour | 2.7 units on a scale | Standard Deviation 1.3 |
| Ibuprofen 400 mg | Pain Relief Rating Score (PRR) | 5 hour | 2.6 units on a scale | Standard Deviation 1.4 |
| Ibuprofen 400 mg | Pain Relief Rating Score (PRR) | 1.5 hour | 2.5 units on a scale | Standard Deviation 1.2 |
| Ibuprofen 400 mg | Pain Relief Rating Score (PRR) | 9 hour | 1.7 units on a scale | Standard Deviation 1.5 |
| Ibuprofen 400 mg | Pain Relief Rating Score (PRR) | 0.25 hour | 0.4 units on a scale | Standard Deviation 0.6 |
| Ibuprofen 400 mg | Pain Relief Rating Score (PRR) | 2 hour | 2.6 units on a scale | Standard Deviation 1.3 |
| Ibuprofen 400 mg | Pain Relief Rating Score (PRR) | 4 hour | 2.7 units on a scale | Standard Deviation 1.4 |
| Ibuprofen 400 mg | Pain Relief Rating Score (PRR) | 0.5 hour | 1.1 units on a scale | Standard Deviation 0.9 |
| Ibuprofen 400 mg | Pain Relief Rating Score (PRR) | 1 hour | 2.1 units on a scale | Standard Deviation 1.1 |
| Ibuprofen 400 mg | Pain Relief Rating Score (PRR) | 7 hour | 2.1 units on a scale | Standard Deviation 1.5 |
| Ibuprofen 400 mg | Pain Relief Rating Score (PRR) | 12 hour | 1.2 units on a scale | Standard Deviation 1.4 |
| Ibuprofen 400 mg | Pain Relief Rating Score (PRR) | 11 hour | 1.3 units on a scale | Standard Deviation 1.5 |
| Ibuprofen 400 mg | Pain Relief Rating Score (PRR) | 10 hour | 1.4 units on a scale | Standard Deviation 1.5 |
| Ibuprofen 400 mg | Pain Relief Rating Score (PRR) | 8 hour | 1.9 units on a scale | Standard Deviation 1.5 |
| Ibuprofen 400 mg | Pain Relief Rating Score (PRR) | 6 hour | 2.4 units on a scale | Standard Deviation 1.5 |
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.01495% CI: [0.08, 0.71]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.03895% CI: [0.02, 0.64]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00395% CI: [0.17, 0.79]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.15595% CI: [-0.09, 0.54]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.13595% CI: [-0.05, 0.39]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.3595% CI: [-0.11, 0.32]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.02495% CI: [0.03, 0.47]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.9, 1.77]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.83, 1.7]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00195% CI: [0.91, 1.78]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.43, 1.3]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00395% CI: [0.16, 0.77]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.0195% CI: [0.1, 0.7]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00295% CI: [0.18, 0.79]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.66, 2.58]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.5, 2.42]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.67, 2.6]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.28, 2.2]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.02295% CI: [0.05, 0.7]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.18195% CI: [-0.1, 0.54]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.01695% CI: [0.07, 0.72]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.98, 2.88]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.72, 2.62]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.01, 2.91]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.68, 2.58]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.06595% CI: [-0.02, 0.61]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.81795% CI: [-0.28, 0.35]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.04395% CI: [0.01, 0.64]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.06, 3.01]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.87, 2.82]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.15, 3.11]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.89, 2.84]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.31295% CI: [-0.16, 0.51]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.9195% CI: [-0.35, 0.31]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.11395% CI: [-0.06, 0.6]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.98, 2.97]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.76, 2.75]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.02, 3.01]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.86, 2.85]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.48295% CI: [-0.22, 0.47]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.57395% CI: [-0.44, 0.24]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.36895% CI: [-0.19, 0.5]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.88, 2.91]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.66, 2.68]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.93, 2.96]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.72, 2.74]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.35295% CI: [-0.19, 0.53]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.77195% CI: [-0.41, 0.3]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.23595% CI: [-0.14, 0.58]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.79, 2.86]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.52, 2.58]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.83, 2.9]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.66, 2.73]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.5195% CI: [-0.25, 0.5]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.44295% CI: [-0.52, 0.23]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.37295% CI: [-0.2, 0.54]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.39, 2.55]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.25, 2.4]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.57, 2.72]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.3, 2.45]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.63995% CI: [-0.31, 0.5]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.80395% CI: [-0.45, 0.35]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.18495% CI: [-0.13, 0.67]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.07, 2.26]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.99, 2.17]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.25, 2.43]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.1, 2.28]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.9195% CI: [-0.44, 0.39]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.60795% CI: [-0.52, 0.3]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.48495% CI: [-0.27, 0.56]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.64, 1.86]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.75, 1.97]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.77, 1.99]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.89, 2.1]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.25695% CI: [-0.67, 0.18]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.52695% CI: [-0.56, 0.29]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.60295% CI: [-0.54, 0.31]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00295% CI: [0.34, 1.56]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00195% CI: [0.38, 1.59]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.65, 1.86]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.61, 1.82]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.22495% CI: [-0.69, 0.16]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.28395% CI: [-0.65, 0.19]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.8695% CI: [-0.39, 0.46]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.72195% CI: [-0.46, 0.32]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.03895% CI: [0.03, 1.22]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.03195% CI: [0.06, 1.24]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.43, 1.62]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00295% CI: [0.36, 1.54]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.12995% CI: [-0.74, 0.09]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.15495% CI: [-0.71, 0.11]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.71495% CI: [-0.34, 0.49]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.21795% CI: [-0.22, 0.96]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.13695% CI: [-0.14, 1.03]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.0195% CI: [0.19, 1.37]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00695% CI: [0.24, 1.41]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.03195% CI: [-0.87, -0.04]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.0795% CI: [-0.79, 0.03]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.82295% CI: [-0.46, 0.37]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.32795% CI: [-0.28, 0.83]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.22495% CI: [-0.21, 0.89]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.02595% CI: [0.08, 1.19]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.01295% CI: [0.15, 1.25]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.0395% CI: [-0.81, -0.04]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.06495% CI: [-0.75, 0.02]ANOVA
Secondary
Participant Global Evaluation of Study Medication
Participant global evaluation of study medication was performed at the 12-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0= Very poor, 1= Poor, 2= Fair, 3= Good, 4= Very Good and 5= Excellent.
Time frame: 12 hour
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Participant Global Evaluation of Study Medication | 1.0 units on a scale | Standard Deviation 1.5 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Participant Global Evaluation of Study Medication | 3.8 units on a scale | Standard Deviation 1.1 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Participant Global Evaluation of Study Medication | 3.4 units on a scale | Standard Deviation 1.2 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Participant Global Evaluation of Study Medication | 3.6 units on a scale | Standard Deviation 1.2 |
| Ibuprofen 400 mg | Participant Global Evaluation of Study Medication | 3.5 units on a scale | Standard Deviation 1.4 |
Comparison: Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.p-value: <0.00195% CI: [0.79, 1.01]Cochran-Mantel-Haenszel
Comparison: Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.p-value: <0.00195% CI: [0.79, 1.01]Cochran-Mantel-Haenszel
Comparison: Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.p-value: <0.00195% CI: [0.73, 0.99]Cochran-Mantel-Haenszel
Comparison: Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.p-value: <0.00195% CI: [0.65, 0.95]Cochran-Mantel-Haenszel
Comparison: Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.p-value: 0.17495% CI: [-0.07, 0.37]Cochran-Mantel-Haenszel
Comparison: Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.p-value: 0.72295% CI: [-0.18, 0.26]Cochran-Mantel-Haenszel
Comparison: Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.p-value: 0.36595% CI: [-0.32, 0.11]Cochran-Mantel-Haenszel
Secondary
Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)
PRID4: sum of PID and PRR at each post-dose time points up to 12 hours. Score range for PRID: -1(worst score) to 7(best score). PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 \[no pain\] to 3 \[worst possible pain\]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID4: -1 (worst score) to 3 (best score). PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief.
Time frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 10 hour | 0.8 units on a scale | Standard Deviation 2.2 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 0.5 hour | 0.3 units on a scale | Standard Deviation 0.9 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 8 hour | 0.7 units on a scale | Standard Deviation 2 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 0.25 hour | 0.3 units on a scale | Standard Deviation 0.6 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 1.5 hour | 0.5 units on a scale | Standard Deviation 1.4 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 6 hour | 0.8 units on a scale | Standard Deviation 2 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 9 hour | 0.8 units on a scale | Standard Deviation 2 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 1 hour | 0.5 units on a scale | Standard Deviation 1.1 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 12 hour | 0.9 units on a scale | Standard Deviation 2.4 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 2 hour | 0.4 units on a scale | Standard Deviation 1.4 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 7 hour | 0.7 units on a scale | Standard Deviation 2 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 4 hour | 0.7 units on a scale | Standard Deviation 1.9 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 5 hour | 0.6 units on a scale | Standard Deviation 1.9 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 11 hour | 0.9 units on a scale | Standard Deviation 2.3 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 3 hour | 0.6 units on a scale | Standard Deviation 1.8 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 1 hour | 4.0 units on a scale | Standard Deviation 1.8 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 11 hour | 1.4 units on a scale | Standard Deviation 2.3 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 4 hour | 4.5 units on a scale | Standard Deviation 1.8 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 6 hour | 3.8 units on a scale | Standard Deviation 2.2 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 5 hour | 4.3 units on a scale | Standard Deviation 1.9 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 8 hour | 2.7 units on a scale | Standard Deviation 2.4 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 12 hour | 1.1 units on a scale | Standard Deviation 2 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 10 hour | 1.7 units on a scale | Standard Deviation 2.3 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 3 hour | 4.6 units on a scale | Standard Deviation 1.8 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 9 hour | 2.2 units on a scale | Standard Deviation 2.4 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 1.5 hour | 4.5 units on a scale | Standard Deviation 1.7 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 0.5 hour | 2.6 units on a scale | Standard Deviation 1.8 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 0.25 hour | 1.0 units on a scale | Standard Deviation 1.3 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 2 hour | 4.6 units on a scale | Standard Deviation 1.8 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 7 hour | 3.3 units on a scale | Standard Deviation 2.3 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 9 hour | 2.2 units on a scale | Standard Deviation 2.3 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 10 hour | 1.7 units on a scale | Standard Deviation 2.2 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 11 hour | 1.5 units on a scale | Standard Deviation 2.2 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 12 hour | 1.2 units on a scale | Standard Deviation 2 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 1 hour | 3.6 units on a scale | Standard Deviation 1.8 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 1.5 hour | 4.1 units on a scale | Standard Deviation 2 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 2 hour | 4.3 units on a scale | Standard Deviation 2.1 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 0.25 hour | 0.7 units on a scale | Standard Deviation 1.1 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 3 hour | 4.4 units on a scale | Standard Deviation 2.2 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 4 hour | 4.3 units on a scale | Standard Deviation 2.3 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 5 hour | 4.1 units on a scale | Standard Deviation 2.4 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 6 hour | 3.9 units on a scale | Standard Deviation 2.4 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 7 hour | 3.4 units on a scale | Standard Deviation 2.4 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 8 hour | 2.9 units on a scale | Standard Deviation 2.3 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 0.5 hour | 2.2 units on a scale | Standard Deviation 1.9 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 6 hour | 4.2 units on a scale | Standard Deviation 2.4 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 4 hour | 4.6 units on a scale | Standard Deviation 2 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 3 hour | 4.7 units on a scale | Standard Deviation 2 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 2 hour | 4.7 units on a scale | Standard Deviation 1.9 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 10 hour | 2.2 units on a scale | Standard Deviation 2.3 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 7 hour | 3.6 units on a scale | Standard Deviation 2.4 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 1.5 hour | 4.5 units on a scale | Standard Deviation 1.8 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 1 hour | 3.9 units on a scale | Standard Deviation 1.9 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 11 hour | 1.9 units on a scale | Standard Deviation 2.2 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 0.5 hour | 2.4 units on a scale | Standard Deviation 1.8 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 8 hour | 2.8 units on a scale | Standard Deviation 2.4 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 12 hour | 1.6 units on a scale | Standard Deviation 2.1 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 5 hour | 4.4 units on a scale | Standard Deviation 2.3 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 0.25 hour | 1.0 units on a scale | Standard Deviation 1.4 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 9 hour | 2.5 units on a scale | Standard Deviation 2.3 |
| Ibuprofen 400 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 6 hour | 3.7 units on a scale | Standard Deviation 2.5 |
| Ibuprofen 400 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 12 hour | 1.7 units on a scale | Standard Deviation 2.2 |
| Ibuprofen 400 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 0.25 hour | 0.6 units on a scale | Standard Deviation 1 |
| Ibuprofen 400 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 0.5 hour | 1.6 units on a scale | Standard Deviation 1.4 |
| Ibuprofen 400 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 1 hour | 3.2 units on a scale | Standard Deviation 1.9 |
| Ibuprofen 400 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 1.5 hour | 3.9 units on a scale | Standard Deviation 1.9 |
| Ibuprofen 400 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 2 hour | 4.2 units on a scale | Standard Deviation 2.1 |
| Ibuprofen 400 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 4 hour | 4.2 units on a scale | Standard Deviation 2.3 |
| Ibuprofen 400 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 5 hour | 4.1 units on a scale | Standard Deviation 2.3 |
| Ibuprofen 400 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 3 hour | 4.3 units on a scale | Standard Deviation 2.2 |
| Ibuprofen 400 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 7 hour | 3.3 units on a scale | Standard Deviation 2.5 |
| Ibuprofen 400 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 8 hour | 3.0 units on a scale | Standard Deviation 2.5 |
| Ibuprofen 400 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 9 hour | 2.5 units on a scale | Standard Deviation 2.4 |
| Ibuprofen 400 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 10 hour | 2.1 units on a scale | Standard Deviation 2.4 |
| Ibuprofen 400 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 11 hour | 1.9 units on a scale | Standard Deviation 2.4 |
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.01495% CI: [0.13, 1.1]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.06695% CI: [-0.03, 0.94]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00495% CI: [0.22, 1.2]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.23295% CI: [-0.19, 0.78]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.06795% CI: [-0.02, 0.66]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.35495% CI: [-0.18, 0.5]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.01795% CI: [0.08, 0.76]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.45, 2.86]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.23, 2.64]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.39, 2.8]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.61, 2.02]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.34, 1.33]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.01495% CI: [0.12, 1.11]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00295% CI: [0.28, 1.27]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.69, 4.22]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.36, 3.89]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.72, 4.26]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.02, 3.54]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.01495% CI: [0.14, 1.21]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.20295% CI: [-0.19, 0.88]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.0195% CI: [0.17, 1.24]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [3.24, 4.76]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.79, 4.31]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [3.27, 4.79]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.72, 4.24]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.05695% CI: [-0.01, 1.05]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.78995% CI: [-0.46, 0.6]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.04295% CI: [0.02, 1.08]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [3.37, 4.98]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [3.06, 4.66]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [3.54, 5.14]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [3.09, 4.69]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.31795% CI: [-0.28, 0.85]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.92295% CI: [-0.59, 0.53]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.11295% CI: [-0.11, 1.02]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [3.27, 4.94]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.92, 4.59]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [3.32, 4.99]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [3.05, 4.72]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.46495% CI: [-0.37, 0.81]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.66795% CI: [-0.71, 0.45]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.36895% CI: [-0.32, 0.86]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [3.08, 4.81]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.77, 4.49]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [3.19, 4.92]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.82, 4.54]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.39795% CI: [-0.34, 0.86]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.86695% CI: [-0.65, 0.55]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.22695% CI: [-0.23, 0.97]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.9, 4.7]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.47, 4.26]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.99, 4.79]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.7, 4.5]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.53695% CI: [-0.43, 0.83]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.46795% CI: [-0.86, 0.39]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.36195% CI: [-0.34, 0.92]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.21, 4.13]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.04, 3.95]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.55, 4.47]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.09, 4]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.70495% CI: [-0.54, 0.8]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.8995% CI: [-0.71, 0.62]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.1795% CI: [-0.2, 1.14]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.72, 3.67]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.61, 3.56]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [2.01, 3.97]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.77, 3.72]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.88295% CI: [-0.74, 0.63]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.6495% CI: [-0.84, 0.52]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.48295% CI: [-0.44, 0.93]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.07, 3.06]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.17, 3.16]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.25, 3.24]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [1.43, 3.41]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.31495% CI: [-1.05, 0.34]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.46995% CI: [-0.95, 0.44]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.61695% CI: [-0.87, 0.52]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00295% CI: [0.57, 2.56]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00295% CI: [0.55, 2.53]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.95, 2.94]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: <0.00195% CI: [0.92, 2.9]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.3395% CI: [-1.04, 0.35]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.28895% CI: [-1.06, 0.32]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.91695% CI: [-0.66, 0.73]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.04195% CI: [0.04, 1.98]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.03495% CI: [0.08, 2.01]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00195% CI: [0.62, 2.56]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00395% CI: [0.52, 2.45]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.17195% CI: [-1.15, 0.2]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.20195% CI: [-1.11, 0.23]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.76395% CI: [-0.57, 0.78]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.17595% CI: [-0.3, 1.61]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.1295% CI: [-0.2, 1.7]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.01495% CI: [0.24, 2.15]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.00795% CI: [0.36, 2.26]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.05495% CI: [-1.32, 0.01]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.09695% CI: [-1.22, 0.1]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.72495% CI: [-0.79, 0.55]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.34595% CI: [-0.46, 1.3]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.22895% CI: [-0.34, 1.41]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.04595% CI: [0.02, 1.78]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.01695% CI: [0.21, 1.96]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.03695% CI: [-1.27, -0.04]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.08195% CI: [-1.15, 0.07]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.p-value: 0.55695% CI: [-0.8, 0.43]ANOVA
Secondary
Time to Confirmed First Perceptible Relief
Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labelled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study. Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure (defined as participant taking rescue medication, or discontinuing due to lack of efficacy) prior to depressing the first stopwatch or until the time of withdrawal (discontinuation).
Time frame: From 0 hour up to 12 hours post-dose
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Confirmed First Perceptible Relief | NA minutes |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Time to Confirmed First Perceptible Relief | 18.5 minutes |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time to Confirmed First Perceptible Relief | 22.8 minutes |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Time to Confirmed First Perceptible Relief | 18.5 minutes |
| Ibuprofen 400 mg | Time to Confirmed First Perceptible Relief | 24.9 minutes |
Comparison: HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.p-value: <0.00195% CI: [5.24, 27.91]Proportional hazards model
Comparison: HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.p-value: <0.00195% CI: [3.86, 20.44]Proportional hazards model
Comparison: HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.p-value: <0.00195% CI: [4.98, 26.42]Proportional hazards model
Comparison: HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.p-value: <0.00195% CI: [3.52, 18.68]Proportional hazards model
Comparison: HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.p-value: 0.01295% CI: [1.09, 2.04]Proportional hazards model
Comparison: HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.p-value: 0.5795% CI: [0.8, 1.49]Proportional hazards model
Comparison: HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.p-value: 0.0395% CI: [1.03, 1.93]Proportional hazards model
Secondary
Time to Onset of Meaningful Pain Relief
Participants evaluated time to meaningful relief by stopping a second stopwatch labelled as meaningful relief at the moment they first began to experience meaningful relief. Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch. Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.
Time frame: From 0 hour up to 12 hours post-dose
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Onset of Meaningful Pain Relief | NA minutes |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Time to Onset of Meaningful Pain Relief | 44.5 minutes |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time to Onset of Meaningful Pain Relief | 54.1 minutes |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Time to Onset of Meaningful Pain Relief | 45.9 minutes |
| Ibuprofen 400 mg | Time to Onset of Meaningful Pain Relief | 56.2 minutes |
Comparison: Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.p-value: <0.00195% CI: [5.52, 29.19]Proportional hazards model
Comparison: Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.p-value: <0.00195% CI: [4.36, 23.02]Proportional hazards model
Comparison: Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.p-value: <0.00195% CI: [5.07, 26.83]Proportional hazards model
Comparison: Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.p-value: <0.00195% CI: [3.74, 19.77]Proportional hazards model
Comparison: Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.p-value: 0.01495% CI: [1.08, 2.02]Proportional hazards model
Comparison: Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.p-value: 0.33295% CI: [0.86, 1.59]Proportional hazards model
Comparison: Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.p-value: 0.05695% CI: [0.99, 1.85]Proportional hazards model
Secondary
Time to Treatment Failure
Time to treatment failure was defined as the time interval from the study drug administration up to the first documentation of treatment failure. Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first.
Time frame: From 0 hour up to 12 hours post-dose
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Treatment Failure | 1.6 hours |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Time to Treatment Failure | 9.7 hours |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time to Treatment Failure | 10.1 hours |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Time to Treatment Failure | 11.1 hours |
| Ibuprofen 400 mg | Time to Treatment Failure | 10.4 hours |
Comparison: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.p-value: <0.00195% CI: [0.17, 0.45]Proportional hazards model
Comparison: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.p-value: <0.00195% CI: [0.15, 0.39]Proportional hazards model
Comparison: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.p-value: <0.00195% CI: [0.13, 0.35]Proportional hazards model
Comparison: Treatment difference (Ibuprofen 400 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.p-value: <0.00195% CI: [0.15, 0.41]Proportional hazards model
Comparison: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.p-value: 0.54995% CI: [0.77, 1.63]Proportional hazards model
Comparison: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.p-value: 0.86395% CI: [0.66, 1.42]Proportional hazards model
Comparison: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.p-value: 0.45495% CI: [0.57, 1.28]Proportional hazards model
Secondary
Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose
Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11: Time-weighted sum of PID scores over 12 hours. SPID11 score range was -10 (worst score) to 20 (best score) for SPID 0-2, -30 (worst score) to 60 (best score) for SPID 0-6, -40 (worst score) to 80 (best score) for SPID 0-8, -60 (worst score) to 120 (best score) for SPID 0-12. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).
Time frame: 0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to12 hours | 4.1 units on a scale | Standard Deviation 28.7 |
| Placebo | Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 6 hours | 1.1 units on a scale | Standard Deviation 11.8 |
| Placebo | Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 8 hours | 1.8 units on a scale | Standard Deviation 16.8 |
| Placebo | Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 2 hours | 0.1 units on a scale | Standard Deviation 2.4 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to12 hours | 44.0 units on a scale | Standard Deviation 25 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 2 hours | 8.8 units on a scale | Standard Deviation 4.3 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 6 hours | 29.9 units on a scale | Standard Deviation 13 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 8 hours | 36.9 units on a scale | Standard Deviation 17.3 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 2 hours | 8.0 units on a scale | Standard Deviation 4.5 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to12 hours | 44.5 units on a scale | Standard Deviation 29.7 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 8 hours | 36.5 units on a scale | Standard Deviation 21.5 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 6 hours | 28.8 units on a scale | Standard Deviation 16.1 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 2 hours | 8.6 units on a scale | Standard Deviation 4 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 6 hours | 30.1 units on a scale | Standard Deviation 14.4 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 8 hours | 37.6 units on a scale | Standard Deviation 19.3 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to12 hours | 46.5 units on a scale | Standard Deviation 27.3 |
| Ibuprofen 400 mg | Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to12 hours | 43.7 units on a scale | Standard Deviation 29.2 |
| Ibuprofen 400 mg | Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 6 hours | 26.8 units on a scale | Standard Deviation 15 |
| Ibuprofen 400 mg | Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 8 hours | 34.2 units on a scale | Standard Deviation 20.3 |
| Ibuprofen 400 mg | Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 2 hours | 7.2 units on a scale | Standard Deviation 4.3 |
Comparison: 0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [7.23, 10.89]ANOVA
Comparison: 0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [6.33, 9.95]ANOVA
Comparison: 0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [6.83, 10.49]ANOVA
Comparison: 0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [5.78, 9.44]ANOVA
Comparison: 0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.02495% CI: [0.19, 2.7]ANOVA
Comparison: 0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.39295% CI: [-0.69, 1.76]ANOVA
Comparison: 0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.10195% CI: [-0.21, 2.3]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [23.97, 36.48]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [21.74, 34.11]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [23.6, 36.12]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [21.33, 33.86]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.22895% CI: [-1.65, 6.92]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.87595% CI: [-3.84, 4.51]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.29995% CI: [-2.02, 6.55]ANOVA
Comparison: 0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [28.48, 45.47]ANOVA
Comparison: 0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [26.7, 43.5]ANOVA
Comparison: 0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [28.6, 45.59]ANOVA
Comparison: 0-8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [26.67, 43.68]ANOVA
Comparison: 0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.54395% CI: [-4.02, 7.63]ANOVA
Comparison: 0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.97995% CI: [-5.75, 5.6]ANOVA
Comparison: 0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.51795% CI: [-3.9, 7.74]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [30.51, 55.41]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [29.9, 54.51]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [32.67, 57.57]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [31.79, 56.71]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.76795% CI: [-9.82, 7.25]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.62995% CI: [-10.36, 6.27]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.84195% CI: [-7.66, 9.39]ANOVA
Secondary
Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose
Pain intensity was assessed on a 4-point categorical pain severity rating scale. SPID4: Time-weighted sum of PID over post-dose time points. SPID4 score range was -2 (worst score) to 6 (best score) for SPID 0-2, -6 (worst score) to 18 (best score) for SPID 0-6, -8 (worst score) to 24 (best score) for SPID 0-8, -12 (worst score) to 36 (best score) for SPID 0-12. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 \[none\] to 3 \[severe\]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -1 (worst score) to 3 (best score).
Time frame: 0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 2 hours | 0.1 units on a scale | Standard Deviation 1 |
| Placebo | Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 6 hours | 0.7 units on a scale | Standard Deviation 4.4 |
| Placebo | Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 8 hours | 1.0 units on a scale | Standard Deviation 6.1 |
| Placebo | Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 12 hours | 2.0 units on a scale | Standard Deviation 10 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 2 hours | 2.7 units on a scale | Standard Deviation 1.5 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 12 hours | 13.3 units on a scale | Standard Deviation 8.8 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 6 hours | 9.1 units on a scale | Standard Deviation 4.5 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 8 hours | 11.2 units on a scale | Standard Deviation 6.1 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 12 hours | 12.9 units on a scale | Standard Deviation 9.9 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 6 hours | 8.5 units on a scale | Standard Deviation 5.4 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 8 hours | 10.7 units on a scale | Standard Deviation 7.2 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 2 hours | 2.4 units on a scale | Standard Deviation 1.5 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 2 hours | 2.7 units on a scale | Standard Deviation 1.4 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 6 hours | 9.3 units on a scale | Standard Deviation 5 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 12 hours | 14.1 units on a scale | Standard Deviation 9.1 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 8 hours | 11.6 units on a scale | Standard Deviation 6.6 |
| Ibuprofen 400 mg | Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 12 hours | 13.0 units on a scale | Standard Deviation 9.4 |
| Ibuprofen 400 mg | Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 8 hours | 10.4 units on a scale | Standard Deviation 6.7 |
| Ibuprofen 400 mg | Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 6 hours | 8.2 units on a scale | Standard Deviation 4.9 |
| Ibuprofen 400 mg | Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose | 0 to 2 hours | 2.2 units on a scale | Standard Deviation 1.4 |
Comparison: 0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [2.01, 3.05]ANOVA
Comparison: 0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [1.72, 2.75]ANOVA
Comparison: 0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [2.04, 3.08]ANOVA
Comparison: 0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [1.57, 2.6]ANOVA
Comparison: 0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.01695% CI: [0.08, 0.81]ANOVA
Comparison: 0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.42895% CI: [-0.21, 0.5]ANOVA
Comparison: 0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.0195% CI: [0.11, 0.84]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [6.59, 10.18]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [5.89, 9.47]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [6.91, 10.5]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [5.86, 9.44]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.2595% CI: [-0.52, 1.99]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.95695% CI: [-1.21, 1.28]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.09995% CI: [-0.2, 2.31]ANOVA
Comparison: 0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [7.78, 12.66]ANOVA
Comparison: 0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [7.06, 11.92]ANOVA
Comparison: 0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [8.28, 13.15]ANOVA
Comparison: 0-8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [7.19, 12.06]ANOVA
Comparison: 0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.49295% CI: [-1.11, 2.3]ANOVA
Comparison: 0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.87395% CI: [-1.83, 1.56]ANOVA
Comparison: 0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.2195% CI: [-0.62, 2.79]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [8.1, 15.2]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [7.4, 14.48]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [9.1, 16.2]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [8.18, 15.26]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.95795% CI: [-2.55, 2.42]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.53495% CI: [-3.25, 1.69]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.46295% CI: [-1.55, 3.41]ANOVA
Secondary
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose
SPRID4: Time-weighted sum of PRR and PID based on 4 point categorical pain severity rating scale (PRID) with score range: -2(worst score) to 14 (best score) for SPRID 0-2, -6 (worst score) to 42 (best score) for SPRID 0-6 and -12 (worst score) to 84 (best score) for SPRID 0-12. PRID: sum of PID and PRR at post-dose time point with score range: -1 (worst score) to 7 (best score). PID calculated by subtracting pain intensity score at post-dose time points (score range: 0 \[none\] to 3 \[severe\]) from baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline score of at least moderate were included). PID total possible score range: -1 (worst score) to 3(best score). PRR assessed on 5-point categorical scale with range: 0 =no relief to 4 =complete relief.
Time frame: 0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dose
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose | 0 to 12 hours | 8.4 units on a scale | Standard Deviation 22 |
| Placebo | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose | 0 to 2 hours | 0.9 units on a scale | Standard Deviation 2 |
| Placebo | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose | 0 to 6 hours | 3.5 units on a scale | Standard Deviation 9.4 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose | 0 to 12 hours | 37.2 units on a scale | Standard Deviation 19.2 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose | 0 to 6 hours | 24.8 units on a scale | Standard Deviation 9.2 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose | 0 to 2 hours | 7.4 units on a scale | Standard Deviation 3 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose | 0 to 2 hours | 6.7 units on a scale | Standard Deviation 3.2 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose | 0 to 6 hours | 23.3 units on a scale | Standard Deviation 11.6 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose | 0 to 12 hours | 36.3 units on a scale | Standard Deviation 21.9 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose | 0 to 6 hours | 25.3 units on a scale | Standard Deviation 10.9 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose | 0 to 12 hours | 39.9 units on a scale | Standard Deviation 21.1 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose | 0 to 2 hours | 7.4 units on a scale | Standard Deviation 3.1 |
| Ibuprofen 400 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose | 0 to 12 hours | 36.9 units on a scale | Standard Deviation 22.4 |
| Ibuprofen 400 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose | 0 to 2 hours | 6.2 units on a scale | Standard Deviation 3.1 |
| Ibuprofen 400 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose | 0 to 6 hours | 22.5 units on a scale | Standard Deviation 11.2 |
Comparison: 0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [5.25, 7.76]ANOVA
Comparison: 0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [4.62, 7.11]ANOVA
Comparison: 0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [5.38, 7.88]ANOVA
Comparison: 0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [4.23, 6.73]ANOVA
Comparison: 0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.02295% CI: [0.15, 1.9]ANOVA
Comparison: 0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.3895% CI: [-0.48, 1.26]ANOVA
Comparison: 0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.0195% CI: [0.28, 2.03]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [17.17, 25.87]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [15.29, 23.95]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [17.89, 26.59]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [15.35, 24.02]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.23795% CI: [-1.21, 4.88]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.96595% CI: [-3.09, 2.95]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.09995% CI: [-0.48, 5.6]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [21.14, 38.73]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [19.48, 37]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [24.31, 41.89]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [21.87, 39.41]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.82195% CI: [-6.86, 5.44]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.4495% CI: [-8.51, 3.71]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.43295% CI: [-3.69, 8.61]ANOVA
Secondary
Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose
TOTPAR: time-weighted sum of PRR scores over 2, 6, 8 and 12 hours. TOTPAR score range was 0 (worst score) to 8 (best score) for TOTPAR 0-2, 0 (worst score) to 24 (best score) for TOTPAR 0-6, 0 (worst score) to 32 (best score) for TOTPAR 0-8, 0 (worst score) to 48 (best score) for TOTPAR 0-12. PRR was assessed on a 5-point categorical pain relief rating scale where 0= No relief to 4= Complete relief.
Time frame: 0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose | 0 to 6 hours | 2.8 units on a scale | Standard Deviation 5.4 |
| Placebo | Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose | 0 to 12 hours | 6.4 units on a scale | Standard Deviation 12.6 |
| Placebo | Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose | 0 to 8 hours | 4.0 units on a scale | Standard Deviation 7.6 |
| Placebo | Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose | 0 to 2 hours | 0.7 units on a scale | Standard Deviation 1.1 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose | 0 to 12 hours | 23.9 units on a scale | Standard Deviation 11.2 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose | 0 to 6 hours | 15.7 units on a scale | Standard Deviation 5.2 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose | 0 to 2 hours | 4.7 units on a scale | Standard Deviation 1.7 |
| Ibuprofen 200 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose | 0 to 8 hours | 19.6 units on a scale | Standard Deviation 7.2 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose | 0 to 8 hours | 18.9 units on a scale | Standard Deviation 8.8 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose | 0 to 2 hours | 4.3 units on a scale | Standard Deviation 1.9 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose | 0 to 12 hours | 23.4 units on a scale | Standard Deviation 12.6 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose | 0 to 6 hours | 14.8 units on a scale | Standard Deviation 6.5 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose | 0 to 2 hours | 4.7 units on a scale | Standard Deviation 1.8 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose | 0 to 6 hours | 16.0 units on a scale | Standard Deviation 6.3 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose | 0 to 8 hours | 20.2 units on a scale | Standard Deviation 8.6 |
| Ibuprofen 300 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose | 0 to 12 hours | 25.8 units on a scale | Standard Deviation 12.9 |
| Ibuprofen 400 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose | 0 to 12 hours | 23.9 units on a scale | Standard Deviation 13.8 |
| Ibuprofen 400 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose | 0 to 2 hours | 4.0 units on a scale | Standard Deviation 1.8 |
| Ibuprofen 400 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose | 0 to 6 hours | 14.3 units on a scale | Standard Deviation 6.7 |
| Ibuprofen 400 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose | 0 to 8 hours | 18.4 units on a scale | Standard Deviation 9.2 |
Comparison: 0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [3.22, 4.73]ANOVA
Comparison: 0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [2.88, 4.39]ANOVA
Comparison: 0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [3.32, 4.83]ANOVA
Comparison: 0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [2.64, 4.14]ANOVA
Comparison: 0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.03195% CI: [0.05, 1.11]ANOVA
Comparison: 0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.3695% CI: [-0.28, 0.77]ANOVA
Comparison: 0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.01195% CI: [0.15, 1.21]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [10.54, 15.73]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [9.35, 14.52]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [10.95, 16.13]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [9.45, 14.63]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.23595% CI: [-0.72, 2.91]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.9195% CI: [-1.91, 1.7]ANOVA
Comparison: 0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.10595% CI: [-0.32, 3.31]ANOVA
Comparison: 0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [12.49, 19.61]ANOVA
Comparison: 0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [11.33, 18.43]ANOVA
Comparison: 0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [13.2, 20.32]ANOVA
Comparison: 0-8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [11.68, 18.78]ANOVA
Comparison: 0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.51495% CI: [-1.66, 3.32]ANOVA
Comparison: 0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.78395% CI: [-2.82, 2.13]ANOVA
Comparison: 0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.22795% CI: [-0.96, 4.02]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [12.95, 23.61]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [11.99, 22.61]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [15.13, 25.78]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: <0.00195% CI: [13.61, 24.24]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.73695% CI: [-4.37, 3.09]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.3995% CI: [-5.32, 2.08]ANOVA
Comparison: 0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.p-value: 0.4295% CI: [-2.19, 5.26]ANOVA