Post-surgical Pain Following Extraction of Molar Teeth
Conditions
Keywords
ibuprofen, acetaminophen, pain, molar extraction
Brief summary
This is a randomized, double blind, placebo-controlled, parallel group, single-center study in approximately 560 subjects to determine the overall analgesic efficacy and safety of a fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to ibuprofen 250 mg alone, acetaminophen 650 mg alone, and to placebo. Subjects will be healthy males and females aged 18-40 years, inclusive, who are experiencing post-operative pain following surgical extraction of 3 or more third molar teeth. Following extraction, subjects must experience, within 5 hours, post-surgical pain of at least moderate severity (on a 4-point categorical scale), confirmed by a Visual Analog Pain Severity Rating Scale (VAS PSR) of at least 50 mm on a 100 mm VAS PSR scale. Eligible subjects will be randomized to receive a single oral dose of study medication under double-blind conditions and then evaluated on site for 12 hours following administration of study medication. Subjects will provide self-ratings of pain severity and pain relief at various time points using categorical and numerical scales. Additionally, subjects will also evaluate the time to first perceptible relief and time to meaningful relief using a double stopwatch method. Finally, at 12 hours, subjects will complete a categorical Global Evaluation of the study medication. A review of any reported adverse events will also be completed.
Detailed description
This is a 12-hour, 4-arm, randomized, double blind, placebo-controlled, parallel group, single-center study in approximately 560 subjects to determine the overall analgesic efficacy and safety of a fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation (administered as two caplets of 125 mg/250 mg IBU/APAP) compared to ibuprofen 250 mg alone, acetaminophen 650 mg alone, and to placebo. Subjects will be healthy males and females aged 18-40 years, inclusive, otherwise healthy, who are experiencing post-operative pain following surgical extraction of 3 or more third molar teeth. Following extraction, subjects must experience, within 5 hours, post-surgical pain of at least moderate severity (on a 4-point categorical scale), confirmed by a Visual Analog Pain Severity Rating Scale (VAS PSR) of at least 50 mm on a 100 mm VAS PSR scale. Upon completion of the baseline scales, eligible subjects will be randomized to receive a single oral dose of study medication under double-blind conditions and then evaluated on site for 12 hours following administration of study medication. At 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose time points, subjects will provide: self-ratings of pain severity using the numerical and categorical PSRs; and self-ratings of pain relief at each time point using a categorical pain relief rating scale. At 12 hours, subjects will also complete a 6-point categorical Global Evaluation of the study medication. Additionally, subjects will also evaluate the time to first perceptible relief and time to meaningful relief using a double stopwatch method up to 12 hours post-dose or until the time of first rescue medication use, whichever is sooner. A review of any reported adverse events will also be completed.
Interventions
2 caplets of Ibuprofen 250 mg / Acetaminophen 500 mg
DRUGIbuprofen 250 mg
2 caplets of Ibuprofen 125 mg
2 tablets of Acetaminophen 325 mg
DRUGPlacebo
2 caplets of Placebo
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Outpatients who have undergone surgical extraction of 3 or more third molars, of which at least 2 must be a partial or complete bony mandibular impaction. * Subject must have at least moderate pain on the 4-point categorical scale, confirmed by at least 50 mm on the 100 mm VAS PSR scale within approximately 5 hours (i.e., less than or equal to 5 hours, 15 minutes) after surgery is completed. * Female subjects are not pregnant or breast feeding. * Informed consent.
Exclusion criteria
* Presence or history of any significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorder determined by the Investigator to place the subject at increased risk, including the presence or history within 2 years of screening. * Acute localized dental alveolar infection at the time of surgery that could confound the post-surgical evaluation. * Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID; or to APAP, tramadol, other opioids, or to their combinations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 0 to 8 Hours Post-dose (SPID11 [0-8]) | 0 to 8 hours post-dose | Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 (0-8): Time-weighted sum of pain intensity difference (PID) scores over 8 hours. SPID11 score range was -40 (worst score) to 80 (best score) for SPID 0-8. 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 6 to 8 Hours Post-dose (SPID11 [6-8]) | 6 to 8 hours post-dose | Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 (6-8): Time-weighted sum of PID scores over 6 to 8 hours. SPID11 score range was -15 (worst score) to 30 (best score) for SPID 6-8. 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-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 8 Hours and 6 to 8 Hours Post-dose | 0 to 8 hours, 6 to 8 hours post-dose | TOTPAR: Time-weighted sum of Pain Relief Rating (PRR) scores over 0 to 8 and 6 to 8 hours. TOTPAR total score range: 0 (worst score) to 32 (best score) for TOTPAR 0-8 and 0 (worst score) to 12 (best score) for TOTPAR 6-8 hours. PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief. |
| Time to Treatment Failure | 0 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 at 6 and 8 Hours | 6 hours, 8 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. |
| Time to Onset of Meaningful Pain Relief | 0 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose | 0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12, 6 to 8 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 and -3 (worst score) to 9 (best score) for SPID 6-8. 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-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post Dose | 0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dose | TOTPAR: Time-weighted sum of PRR scores over 2, 6 and 12 hours. TOTPAR total score range: 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 which ranges from 0 =no relief to 4 =complete relief. |
| Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose | 0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12, 6 to 8 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, -8 (worst score) to 56 (best score) for SPRID 0-8, -12 (worst score) to 84 (best score) for SPRID 0-12 and -3 (worst score) to 21 (best score) for SPRID 6-8 hours. 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 to Confirmed Onset of First Perceptible Relief | 0 to 12 hours post-dose | Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labeled '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. |
| 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. |
| 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. |
| Participant's Global Evaluation of Study Medication | 0 to 12 hours post-dose | 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. |
| 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. |
| Pain Relief Rating (PRR) Score | 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 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). |
| 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). |
| 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 Scores on 11-Point Numerical Scale (SPID11) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post-dose | 0 to 2 hours, 0 to 6 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, -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) to 10 (best). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received Placebo as a single oral dose caplet during the study of 12 hours. | 56 |
| Ibuprofen 250 mg + Acetaminophen 500 mg Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study. | 172 |
| Ibuprofen 250 mg Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study. | 175 |
| Acetaminophen 650 mg Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study. | 165 |
| Total | 568 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 | 5 |
Baseline characteristics
| Characteristic | Placebo | Ibuprofen 250 mg + Acetaminophen 500 mg | Ibuprofen 250 mg | Acetaminophen 650 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 19.6 years STANDARD_DEVIATION 3 | 19.3 years STANDARD_DEVIATION 1.8 | 19.7 years STANDARD_DEVIATION 2.7 | 19.4 years STANDARD_DEVIATION 2.1 | 19.5 years STANDARD_DEVIATION 2.3 |
| Sex: Female, Male Female | 34 Participants | 102 Participants | 102 Participants | 97 Participants | 335 Participants |
| Sex: Female, Male Male | 22 Participants | 70 Participants | 73 Participants | 68 Participants | 233 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 19 / 56 | 21 / 172 | 37 / 175 | 41 / 165 |
| serious Total, serious adverse events | 0 / 56 | 0 / 172 | 0 / 175 | 0 / 165 |
Outcome results
Primary
Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 0 to 8 Hours Post-dose (SPID11 [0-8])
Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 (0-8): Time-weighted sum of pain intensity difference (PID) scores over 8 hours. SPID11 score range was -40 (worst score) to 80 (best score) for SPID 0-8. 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 8 hours post-dose
Population: FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 0 to 8 Hours Post-dose (SPID11 [0-8]) | 4.1 units on a scale | Standard Deviation 19 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 0 to 8 Hours Post-dose (SPID11 [0-8]) | 34.3 units on a scale | Standard Deviation 19.6 |
| Ibuprofen 250 mg | Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 0 to 8 Hours Post-dose (SPID11 [0-8]) | 28.9 units on a scale | Standard Deviation 20.5 |
| Acetaminophen 650 mg | Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 0 to 8 Hours Post-dose (SPID11 [0-8]) | 19.4 units on a scale | Standard Deviation 20 |
Comparison: Treatment difference and 95 percent (%) confidence interval (CI) were based on LS Mean from analysis of covariance (ANCOVA) with treatment, gender, baseline categorical pain severity rating (PSR) as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [24.14, 36.02]ANCOVA
Comparison: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.00895% CI: [1.51, 9.8]ANCOVA
Comparison: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [10.55, 18.97]ANCOVA
Comparison: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [18.5, 30.35]ANCOVA
Comparison: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [9.35, 21.29]ANCOVA
Comparison: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [4.9, 13.31]ANCOVA
Secondary
Cumulative Percentage of Participants With Treatment Failure at 6 and 8 Hours
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: 6 hours, 8 hours post-dose
Population: FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Placebo | Cumulative Percentage of Participants With Treatment Failure at 6 and 8 Hours | 6 hour | 67.9 percentage of participants | 7.9 |
| Placebo | Cumulative Percentage of Participants With Treatment Failure at 6 and 8 Hours | 8 hour | 69.6 percentage of participants | 3.8 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure at 6 and 8 Hours | 8 hour | 24.4 percentage of participants | 4.1 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure at 6 and 8 Hours | 6 hour | 10.5 percentage of participants | 8.5 |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Treatment Failure at 6 and 8 Hours | 6 hour | 21.7 percentage of participants | 9 |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Treatment Failure at 6 and 8 Hours | 8 hour | 33.1 percentage of participants | 4 |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Treatment Failure at 6 and 8 Hours | 6 hour | 38.8 percentage of participants | 9.1 |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Treatment Failure at 6 and 8 Hours | 8 hour | 51.5 percentage of participants | 4 |
Comparison: At 8 hour: Treatment difference and its associated 95% CI were calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-58.96, -31.58]Cochran-Mantel-Haenszel
Comparison: At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.p-value: 0.06495% CI: [-18.27, 0.5]Cochran-Mantel-Haenszel
Comparison: At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-36.91, -17.05]ANOVA
Comparison: At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-50.45, -22.07]Cochran-Mantel-Haenszel
Comparison: At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.p-value: 0.0195% CI: [-32.64, -4.52]Cochran-Mantel-Haenszel
Comparison: At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-28.44, -7.9]Cochran-Mantel-Haenszel
Comparison: At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-70.44, -44.72]Cochran-Mantel-Haenszel
Comparison: At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.p-value: 0.00495% CI: [-18.99, -3.57]Cochran-Mantel-Haenszel
Comparison: At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-36.77, -19.35]Cochran-Mantel-Haenszel
Comparison: At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-59.98, -32.04]Cochran-Mantel-Haenszel
Comparison: At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-43.65, -15.75]Cochran-Mantel-Haenszel
Comparison: At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-26.59, -7.29]Cochran-Mantel-Haenszel
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: 0 to 12 hours post-dose
Population: FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment. Here, number of participants analyzed signifies those participants who had the event (meaningful pain relief).
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Placebo | Time to Onset of Meaningful Pain Relief | NA minutes | 95% Confidence Interval 8.8 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time to Onset of Meaningful Pain Relief | 47.9 minutes | 95% Confidence Interval 9.2 |
| Ibuprofen 250 mg | Time to Onset of Meaningful Pain Relief | 65.9 minutes | 95% Confidence Interval 8.9 |
| Acetaminophen 650 mg | Time to Onset of Meaningful Pain Relief | 56.6 minutes | 95% Confidence Interval 8.8 |
Comparison: p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.p-value: <0.001Gehan-Wilcoxon test
Comparison: p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.p-value: 0.003Gehan-Wilcoxon test
Comparison: p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.p-value: 0.031Gehan-Wilcoxon test
Comparison: p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.p-value: <0.001Gehan-Wilcoxon test
Comparison: p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.p-value: <0.001Gehan-Wilcoxon test
Comparison: p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.p-value: 0.631Gehan-Wilcoxon test
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: 0 to 12 hours post-dose
Population: FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Placebo | Time to Treatment Failure | 107.0 minutes | 95% Confidence Interval 8.8 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time to Treatment Failure | 629.0 minutes | 95% Confidence Interval 9.2 |
| Ibuprofen 250 mg | Time to Treatment Failure | 608.5 minutes | 95% Confidence Interval 8.9 |
| Acetaminophen 650 mg | Time to Treatment Failure | 449.0 minutes | 95% Confidence Interval 8.8 |
Comparison: p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.p-value: <0.001Gehan-Wilcoxon test
Comparison: p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.p-value: 0.069Gehan-Wilcoxon test
Comparison: p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.p-value: <0.001Gehan-Wilcoxon test
Comparison: p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.p-value: <0.001Gehan-Wilcoxon test
Comparison: p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.p-value: <0.001Gehan-Wilcoxon test
Comparison: p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.p-value: 0.005Gehan-Wilcoxon test
Secondary
Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 6 to 8 Hours Post-dose (SPID11 [6-8])
Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 (6-8): Time-weighted sum of PID scores over 6 to 8 hours. SPID11 score range was -15 (worst score) to 30 (best score) for SPID 6-8. 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: 6 to 8 hours post-dose
Population: FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 6 to 8 Hours Post-dose (SPID11 [6-8]) | 1.9 units on a scale | Standard Deviation 8.8 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 6 to 8 Hours Post-dose (SPID11 [6-8]) | 11.3 units on a scale | Standard Deviation 9.2 |
| Ibuprofen 250 mg | Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 6 to 8 Hours Post-dose (SPID11 [6-8]) | 9.5 units on a scale | Standard Deviation 8.9 |
| Acetaminophen 650 mg | Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 6 to 8 Hours Post-dose (SPID11 [6-8]) | 5.6 units on a scale | Standard Deviation 8.8 |
Comparison: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [6.59, 11.94]ANCOVA
Comparison: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.05395% CI: [-0.03, 3.71]ANCOVA
Comparison: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [3.69, 7.49]ANCOVA
Comparison: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [4.75, 10.09]ANCOVA
Comparison: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.00895% CI: [0.98, 6.36]ANCOVA
Comparison: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [1.85, 5.64]ANCOVA
Secondary
Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 8 Hours and 6 to 8 Hours Post-dose
TOTPAR: Time-weighted sum of Pain Relief Rating (PRR) scores over 0 to 8 and 6 to 8 hours. TOTPAR total score range: 0 (worst score) to 32 (best score) for TOTPAR 0-8 and 0 (worst score) to 12 (best score) for TOTPAR 6-8 hours. 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 to 8 hours, 6 to 8 hours post-dose
Population: FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 8 Hours and 6 to 8 Hours Post-dose | 0 to 8 hours | 5.3 units on a scale | Standard Deviation 7.9 |
| Placebo | Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 8 Hours and 6 to 8 Hours Post-dose | 6 to 8 hours | 2.3 units on a scale | Standard Deviation 3.8 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 8 Hours and 6 to 8 Hours Post-dose | 6 to 8 hours | 6.2 units on a scale | Standard Deviation 4.1 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 8 Hours and 6 to 8 Hours Post-dose | 0 to 8 hours | 18.4 units on a scale | Standard Deviation 8.5 |
| Ibuprofen 250 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 8 Hours and 6 to 8 Hours Post-dose | 0 to 8 hours | 15.4 units on a scale | Standard Deviation 9 |
| Ibuprofen 250 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 8 Hours and 6 to 8 Hours Post-dose | 6 to 8 hours | 5.1 units on a scale | Standard Deviation 4 |
| Acetaminophen 650 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 8 Hours and 6 to 8 Hours Post-dose | 0 to 8 hours | 11.4 units on a scale | Standard Deviation 9.1 |
| Acetaminophen 650 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 8 Hours and 6 to 8 Hours Post-dose | 6 to 8 hours | 3.5 units on a scale | Standard Deviation 4 |
Comparison: 0-8 hours: Treatment difference and 95% CI were based on LS Mean from analysis of variance (ANOVA) with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [10.39, 15.71]ANOVA
Comparison: 0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00295% CI: [1.15, 4.86]ANOVA
Comparison: 0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [5.06, 8.83]ANOVA
Comparison: 0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [7.39, 12.7]ANOVA
Comparison: 0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [3.44, 8.78]ANOVA
Comparison: 0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [2.06, 5.81]ANOVA
Comparison: 6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [2.63, 5.05]ANOVA
Comparison: 6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.01395% CI: [0.23, 1.92]ANOVA
Comparison: 6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.83, 3.55]ANOVA
Comparison: 6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.56, 3.98]ANOVA
Comparison: 6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.06495% CI: [-0.07, 2.37]ANOVA
Comparison: 6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.76, 2.47]ANOVA
Other Pre-specified
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: FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 0.25 hour | 8.9 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 9 hour | 28.6 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 6 hour | 28.6 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 1 hour | 21.4 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 7 hour | 28.6 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 8 hour | 28.6 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 1.5 hour | 25.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 0.5 hour | 16.1 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 11 hour | 28.6 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 2 hour | 25.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 3 hour | 28.6 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 10 hour | 28.6 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 4 hour | 28.6 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 12 hour | 28.6 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 5 hour | 28.6 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 5 hour | 86.6 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 9 hour | 86.6 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 2 hour | 85.5 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 6 hour | 86.6 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 0.5 hour | 66.9 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 8 hour | 86.6 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 10 hour | 86.6 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 7 hour | 86.6 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 1 hour | 81.4 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 4 hour | 86.6 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 12 hour | 86.6 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 11 hour | 86.6 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 3 hour | 86.6 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 1.5 hour | 84.9 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 0.25 hour | 29.7 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 5 hour | 79.4 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 0.25 hour | 25.1 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 0.5 hour | 61.7 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 1 hour | 77.1 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 1.5 hour | 79.4 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 2 hour | 79.4 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 3 hour | 79.4 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 4 hour | 79.4 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 6 hour | 79.4 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 7 hour | 79.4 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 8 hour | 79.4 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 9 hour | 79.4 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 10 hour | 79.4 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 11 hour | 79.4 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 12 hour | 79.4 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 4 hour | 71.5 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 0.5 hour | 57.0 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 9 hour | 71.5 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 3 hour | 71.5 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 2 hour | 71.5 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 0.25 hour | 26.1 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 10 hour | 71.5 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 1.5 hour | 71.5 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 1 hour | 71.5 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 12 hour | 71.5 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 7 hour | 71.5 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 6 hour | 71.5 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 11 hour | 71.5 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 8 hour | 71.5 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 5 hour | 71.5 percentage of participants |
Comparison: 0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [10.54, 30.94]Cochran-Mantel-Haenszel
Comparison: 0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.34295% CI: [-4.81, 13.86]Cochran-Mantel-Haenszel
Comparison: 0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.45995% CI: [-5.98, 13.22]Cochran-Mantel-Haenszel
Comparison: 0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.00195% CI: [6.24, 26.17]Cochran-Mantel-Haenszel
Comparison: 0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [7.42, 27.31]Cochran-Mantel-Haenszel
Comparison: 0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.84995% CI: [-10.2, 8.42]Cochran-Mantel-Haenszel
Comparison: 0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [39.53, 62.62]Cochran-Mantel-Haenszel
Comparison: 0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.31895% CI: [-4.97, 15.3]Cochran-Mantel-Haenszel
Comparison: 0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.06295% CI: [-0.49, 20.21]Cochran-Mantel-Haenszel
Comparison: 0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [33.45, 57.76]Cochran-Mantel-Haenszel
Comparison: 0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [28.76, 53.38]Cochran-Mantel-Haenszel
Comparison: 0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.37495% CI: [-5.7, 15.17]Cochran-Mantel-Haenszel
Comparison: 1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [47.93, 72.26]Cochran-Mantel-Haenszel
Comparison: 1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.32395% CI: [-4.22, 12.81]Cochran-Mantel-Haenszel
Comparison: 1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.03295% CI: [0.86, 18.86]Cochran-Mantel-Haenszel
Comparison: 1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [43.11, 68.2]Cochran-Mantel-Haenszel
Comparison: 1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [37.71, 63.05]Cochran-Mantel-Haenszel
Comparison: 1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.23295% CI: [-3.58, 14.8]Cochran-Mantel-Haenszel
Comparison: 1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [47.39, 72.46]Cochran-Mantel-Haenszel
Comparison: 1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.17995% CI: [-2.52, 13.53]Cochran-Mantel-Haenszel
Comparison: 1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.00395% CI: [4.65, 22.1]Cochran-Mantel-Haenszel
Comparison: 1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [41.36, 67.29]Cochran-Mantel-Haenszel
Comparison: 1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [33.5, 59.99]Cochran-Mantel-Haenszel
Comparison: 1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.08795% CI: [-1.15, 16.97]Cochran-Mantel-Haenszel
Comparison: 2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [47.99, 73.03]Cochran-Mantel-Haenszel
Comparison: 2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.13595% CI: [-1.89, 14.05]Cochran-Mantel-Haenszel
Comparison: 2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.00295% CI: [5.3, 22.64]Cochran-Mantel-Haenszel
Comparison: 2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [41.36, 67.29]Cochran-Mantel-Haenszel
Comparison: 2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [33.5, 59.99]Cochran-Mantel-Haenszel
Comparison: 2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.08795% CI: [-1.15, 16.97]Cochran-Mantel-Haenszel
Comparison: 3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [45.24, 71]Cochran-Mantel-Haenszel
Comparison: 3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.07195% CI: [-0.63, 15.1]Cochran-Mantel-Haenszel
Comparison: 3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [6.55, 23.69]Cochran-Mantel-Haenszel
Comparison: 3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [37.39, 64.09]Cochran-Mantel-Haenszel
Comparison: 3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [29.56, 56.75]Cochran-Mantel-Haenszel
Comparison: 3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.08795% CI: [-1.15, 16.97]Cochran-Mantel-Haenszel
Comparison: 4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [45.24, 71]Cochran-Mantel-Haenszel
Comparison: 4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.07195% CI: [-0.63, 15.1]Cochran-Mantel-Haenszel
Comparison: 4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [6.55, 23.69]Cochran-Mantel-Haenszel
Comparison: 4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [37.39, 64.09]Cochran-Mantel-Haenszel
Comparison: 4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [29.56, 56.75]Cochran-Mantel-Haenszel
Comparison: 4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.08795% CI: [-1.15, 16.97]Cochran-Mantel-Haenszel
Comparison: 5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [45.24, 71]Cochran-Mantel-Haenszel
Comparison: 5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.07195% CI: [-0.63, 15.1]Cochran-Mantel-Haenszel
Comparison: 5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [6.55, 23.69]Cochran-Mantel-Haenszel
Comparison: 5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [37.39, 64.09]Cochran-Mantel-Haenszel
Comparison: 5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [29.56, 56.75]Cochran-Mantel-Haenszel
Comparison: 5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.08795% CI: [-1.15, 16.97]Cochran-Mantel-Haenszel
Comparison: 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [45.24, 71]Cochran-Mantel-Haenszel
Comparison: 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.07195% CI: [-0.63, 15.1]Cochran-Mantel-Haenszel
Comparison: 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [6.55, 23.69]Cochran-Mantel-Haenszel
Comparison: 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [37.39, 64.09]Cochran-Mantel-Haenszel
Comparison: 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [29.56, 56.75]Cochran-Mantel-Haenszel
Comparison: 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.08795% CI: [-1.15, 16.97]Cochran-Mantel-Haenszel
Comparison: 7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [45.24, 71]Cochran-Mantel-Haenszel
Comparison: 7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.07195% CI: [-0.63, 15.1]Cochran-Mantel-Haenszel
Comparison: 7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [6.55, 23.69]Cochran-Mantel-Haenszel
Comparison: 7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [37.39, 64.09]Cochran-Mantel-Haenszel
Comparison: 7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [29.56, 56.75]Cochran-Mantel-Haenszel
Comparison: 7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.08795% CI: [-1.15, 16.97]Cochran-Mantel-Haenszel
Comparison: 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [45.24, 71]Cochran-Mantel-Haenszel
Comparison: 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.07195% CI: [-0.63, 15.1]Cochran-Mantel-Haenszel
Comparison: 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [6.55, 23.69]Cochran-Mantel-Haenszel
Comparison: 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [37.39, 64.09]Cochran-Mantel-Haenszel
Comparison: 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [29.56, 56.75]Cochran-Mantel-Haenszel
Comparison: 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.08795% CI: [-1.15, 16.97]Cochran-Mantel-Haenszel
Comparison: 9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scoresp-value: <0.00195% CI: [45.24, 71]Cochran-Mantel-Haenszel
Comparison: 9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.07195% CI: [-0.63, 15.1]Cochran-Mantel-Haenszel
Comparison: 9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [6.55, 23.69]Cochran-Mantel-Haenszel
Comparison: 9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scoresp-value: <0.00195% CI: [37.39, 64.09]Cochran-Mantel-Haenszel
Comparison: 9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [29.56, 56.75]Cochran-Mantel-Haenszel
Comparison: 9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scoresp-value: 0.08795% CI: [-1.15, 16.97]Cochran-Mantel-Haenszel
Comparison: 10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [45.24, 71]Cochran-Mantel-Haenszel
Comparison: 10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.07195% CI: [-0.63, 15.1]Cochran-Mantel-Haenszel
Comparison: 10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [6.55, 23.69]Cochran-Mantel-Haenszel
Comparison: 10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [37.39, 64.09]Cochran-Mantel-Haenszel
Comparison: 10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [29.56, 56.75]Cochran-Mantel-Haenszel
Comparison: 10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.08795% CI: [-1.15, 16.97]Cochran-Mantel-Haenszel
Comparison: 11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [45.24, 71]Cochran-Mantel-Haenszel
Comparison: 11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.07195% CI: [-0.63, 15.1]Cochran-Mantel-Haenszel
Comparison: 11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [6.55, 23.69]Cochran-Mantel-Haenszel
Comparison: 11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [37.39, 64.09]Cochran-Mantel-Haenszel
Comparison: 11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [29.56, 56.75]Cochran-Mantel-Haenszel
Comparison: 11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.08795% CI: [-1.15, 16.97]Cochran-Mantel-Haenszel
Comparison: 12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [45.24, 71]Cochran-Mantel-Haenszel
Comparison: 12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.07195% CI: [-0.63, 15.1]Cochran-Mantel-Haenszel
Comparison: 12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [6.55, 23.69]Cochran-Mantel-Haenszel
Comparison: 12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [37.39, 64.09]Cochran-Mantel-Haenszel
Comparison: 12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [29.56, 56.75]Cochran-Mantel-Haenszel
Comparison: 12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.08795% CI: [-1.15, 16.97]Cochran-Mantel-Haenszel
Other Pre-specified
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: FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 7 hour | 26.8 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 5 hour | 26.8 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 2 hour | 16.1 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 0.5 hour | 0.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 4 hour | 23.2 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 3 hour | 21.4 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 0.25 hour | 0.0 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 10 hour | 28.6 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 6 hour | 26.8 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 1 hour | 3.6 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 12 hour | 28.6 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 9 hour | 26.8 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 8 hour | 26.8 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 1.5 hour | 8.9 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 11 hour | 28.6 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 9 hour | 85.5 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 0.25 hour | 1.2 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 0.5 hour | 21.5 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 1 hour | 59.3 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 1.5 hour | 68.6 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 2 hour | 82.0 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 3 hour | 82.0 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 4 hour | 83.1 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 5 hour | 84.3 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 6 hour | 85.5 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 7 hour | 85.5 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 8 hour | 85.5 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 10 hour | 85.5 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 11 hour | 85.5 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Meaningful Relief | 12 hour | 85.5 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Meaningful Relief | 11 hour | 79.4 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Meaningful Relief | 9 hour | 78.9 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Meaningful Relief | 7 hour | 78.9 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Meaningful Relief | 0.5 hour | 13.7 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Meaningful Relief | 6 hour | 78.9 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Meaningful Relief | 10 hour | 79.4 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Meaningful Relief | 5 hour | 78.3 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Meaningful Relief | 0.25 hour | 0.0 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Meaningful Relief | 3 hour | 75.4 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Meaningful Relief | 8 hour | 78.9 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Meaningful Relief | 2 hour | 75.4 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Meaningful Relief | 1.5 hour | 60.0 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Meaningful Relief | 4 hour | 77.1 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Meaningful Relief | 1 hour | 46.3 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Meaningful Relief | 12 hour | 79.4 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Meaningful Relief | 1.5 hour | 58.2 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Meaningful Relief | 5 hour | 69.1 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Meaningful Relief | 6 hour | 69.7 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Meaningful Relief | 11 hour | 71.5 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Meaningful Relief | 7 hour | 69.7 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Meaningful Relief | 1 hour | 52.1 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Meaningful Relief | 8 hour | 70.3 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Meaningful Relief | 0.5 hour | 21.8 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Meaningful Relief | 9 hour | 71.5 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Meaningful Relief | 12 hour | 71.5 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Meaningful Relief | 2 hour | 67.3 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Meaningful Relief | 10 hour | 71.5 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Meaningful Relief | 3 hour | 67.3 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Meaningful Relief | 0.25 hour | 1.8 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Meaningful Relief | 4 hour | 67.9 percentage of participants |
Comparison: 0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.15695% CI: [-0.44, 2.75]Cochran-Mantel-Haenszel
Comparison: 0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.15595% CI: [-0.44, 2.76]Cochran-Mantel-Haenszel
Comparison: 0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.60595% CI: [-3.27, 1.9]Cochran-Mantel-Haenszel
Comparison: 0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.07995% CI: [-0.21, 3.89]Cochran-Mantel-Haenszel
Comparison: 0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.07895% CI: [-3.9, 0.21]Cochran-Mantel-Haenszel
Comparison: 0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [15.33, 27.62]Cochran-Mantel-Haenszel
Comparison: 0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.05695% CI: [-0.19, 15.77]Cochran-Mantel-Haenszel
Comparison: 0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.93495% CI: [-9.18, 8.43]Cochran-Mantel-Haenszel
Comparison: 0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [8.58, 18.77]Cochran-Mantel-Haenszel
Comparison: 0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [15.64, 28.28]Cochran-Mantel-Haenszel
Comparison: 0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.0595% CI: [-16.4, -0.01]Cochran-Mantel-Haenszel
Comparison: 1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [47.05, 64.73]Cochran-Mantel-Haenszel
Comparison: 1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.01595% CI: [2.5, 23.49]Cochran-Mantel-Haenszel
Comparison: 1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.18895% CI: [-3.51, 17.82]Cochran-Mantel-Haenszel
Comparison: 1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [33.85, 51.38]Cochran-Mantel-Haenszel
Comparison: 1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [39.63, 57.54]Cochran-Mantel-Haenszel
Comparison: 1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.26695% CI: [-16.51, 4.55]Cochran-Mantel-Haenszel
Comparison: 1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [49.63, 69.9]Cochran-Mantel-Haenszel
Comparison: 1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.09495% CI: [-1.46, 18.69]Cochran-Mantel-Haenszel
Comparison: 1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.04795% CI: [0.15, 20.72]Cochran-Mantel-Haenszel
Comparison: 1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [40.5, 61.4]Cochran-Mantel-Haenszel
Comparison: 1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [38.79, 59.89]Cochran-Mantel-Haenszel
Comparison: 1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.73495% CI: [-8.56, 12.14]Cochran-Mantel-Haenszel
Comparison: 2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [46.88, 70.03]Cochran-Mantel-Haenszel
Comparison: 2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.15295% CI: [-2.57, 16.59]Cochran-Mantel-Haenszel
Comparison: 2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.07395% CI: [-0.83, 19.82]Cochran-Mantel-Haenszel
Comparison: 2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [39.38, 63.21]Cochran-Mantel-Haenszel
Comparison: 2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [37.5, 61.47]Cochran-Mantel-Haenszel
Comparison: 2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.69495% CI: [-7.91, 11.89]Cochran-Mantel-Haenszel
Comparison: 3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [48.37, 72.84]Cochran-Mantel-Haenszel
Comparison: 3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.13595% CI: [-2.05, 15.2]Cochran-Mantel-Haenszel
Comparison: 3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.00295% CI: [5.5, 23.97]Cochran-Mantel-Haenszel
Comparison: 3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [41.31, 66.32]Cochran-Mantel-Haenszel
Comparison: 3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [33.21, 58.66]Cochran-Mantel-Haenszel
Comparison: 3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.09195% CI: [-1.32, 17.69]Cochran-Mantel-Haenszel
Comparison: 4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [47.59, 72.42]Cochran-Mantel-Haenszel
Comparison: 4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.15995% CI: [-2.36, 14.43]Cochran-Mantel-Haenszel
Comparison: 4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [6.23, 24.41]Cochran-Mantel-Haenszel
Comparison: 4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [41.08, 66.5]Cochran-Mantel-Haenszel
Comparison: 4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [31.72, 57.81]Cochran-Mantel-Haenszel
Comparison: 4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.05295% CI: [-0.08, 18.64]Cochran-Mantel-Haenszel
Comparison: 5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [44.75, 70.39]Cochran-Mantel-Haenszel
Comparison: 5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.14795% CI: [-2.13, 14.25]Cochran-Mantel-Haenszel
Comparison: 5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [6.39, 24.21]Cochran-Mantel-Haenszel
Comparison: 5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [38.16, 64.48]Cochran-Mantel-Haenszel
Comparison: 5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [28.74, 55.82]Cochran-Mantel-Haenszel
Comparison: 5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.04995% CI: [0.04, 18.49]Cochran-Mantel-Haenszel
Comparison: 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [45.93, 71.49]Cochran-Mantel-Haenszel
Comparison: 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.10595% CI: [-1.38, 14.67]Cochran-Mantel-Haenszel
Comparison: 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [7.08, 24.63]Cochran-Mantel-Haenszel
Comparison: 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [38.76, 65.04]Cochran-Mantel-Haenszel
Comparison: 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [29.44, 56.44]Cochran-Mantel-Haenszel
Comparison: 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.04895% CI: [0.06, 18.4]Cochran-Mantel-Haenszel
Comparison: 7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [45.93, 71.49]Cochran-Mantel-Haenszel
Comparison: 7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.10595% CI: [-1.38, 14.67]Cochran-Mantel-Haenszel
Comparison: 7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [7.08, 24.63]Cochran-Mantel-Haenszel
Comparison: 7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [38.76, 65.04]Cochran-Mantel-Haenszel
Comparison: 7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [29.44, 56.44]Cochran-Mantel-Haenszel
Comparison: 7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.04895% CI: [0.06, 18.4]Cochran-Mantel-Haenszel
Comparison: 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scoresp-value: <0.00195% CI: [45.93, 71.49]Cochran-Mantel-Haenszel
Comparison: 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scoresp-value: 0.10595% CI: [-1.38, 14.67]Cochran-Mantel-Haenszel
Comparison: 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [6.48, 23.97]Cochran-Mantel-Haenszel
Comparison: 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [38.76, 65.04]Cochran-Mantel-Haenszel
Comparison: 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [30.15, 57.07]Cochran-Mantel-Haenszel
Comparison: 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.06595% CI: [-0.55, 17.76]Cochran-Mantel-Haenszel
Comparison: 9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [45.93, 71.49]Cochran-Mantel-Haenszel
Comparison: 9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.10595% CI: [-1.38, 14.67]Cochran-Mantel-Haenszel
Comparison: 9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.00295% CI: [5.3, 22.67]Cochran-Mantel-Haenszel
Comparison: 9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [38.76, 65.04]Cochran-Mantel-Haenszel
Comparison: 9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [31.51, 58.26]Cochran-Mantel-Haenszel
Comparison: 9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.11395% CI: [-1.73, 16.45]Cochran-Mantel-Haenszel
Comparison: 10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [43.95, 69.94]Cochran-Mantel-Haenszel
Comparison: 10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.13695% CI: [-1.91, 14.05]Cochran-Mantel-Haenszel
Comparison: 10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.00295% CI: [5.3, 22.67]Cochran-Mantel-Haenszel
Comparison: 10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [37.39, 64.09]Cochran-Mantel-Haenszel
Comparison: 10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [29.56, 56.75]Cochran-Mantel-Haenszel
Comparison: 10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.08795% CI: [-1.15, 16.97]Cochran-Mantel-Haenszel
Comparison: 11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [43.95, 69.94]Cochran-Mantel-Haenszel
Comparison: 11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.13695% CI: [-1.91, 14.05]Cochran-Mantel-Haenszel
Comparison: 11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.00295% CI: [5.3, 22.67]Cochran-Mantel-Haenszel
Comparison: 11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [37.39, 64.09]Cochran-Mantel-Haenszel
Comparison: 11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [29.56, 56.75]Cochran-Mantel-Haenszel
Comparison: 11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.08795% CI: [-1.15, 16.97]Cochran-Mantel-Haenszel
Comparison: 12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [43.95, 69.94]Cochran-Mantel-Haenszel
Comparison: 12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.13695% CI: [-1.91, 14.05]Cochran-Mantel-Haenszel
Comparison: 12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.00295% CI: [5.3, 22.67]Cochran-Mantel-Haenszel
Comparison: 12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [37.39, 64.09]Cochran-Mantel-Haenszel
Comparison: 12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [29.56, 56.75]Cochran-Mantel-Haenszel
Comparison: 12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.08795% CI: [-1.15, 16.97]Cochran-Mantel-Haenszel
Other Pre-specified
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: FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 10 hour | 69.6 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 12 hour | 71.4 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 8 hour | 69.6 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 1.5 hour | 39.3 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 9 hour | 69.6 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 3 hour | 62.5 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 4 hour | 64.3 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 2 hour | 51.8 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 11 hour | 69.6 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 5 hour | 66.1 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 6 hour | 67.9 percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 7 hour | 69.6 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 2 hour | 4.1 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 7 hour | 16.9 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 4 hour | 7.6 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 9 hour | 35.5 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 10 hour | 46.5 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 8 hour | 24.4 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 1.5 hour | 2.9 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 6 hour | 10.5 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 5 hour | 8.1 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 3 hour | 7.0 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 12 hour | 55.8 percentage of participants |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Cumulative Percentage of Participants With Treatment Failure | 11 hour | 51.7 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Treatment Failure | 8 hour | 33.1 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Treatment Failure | 1.5 hour | 6.9 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Treatment Failure | 2 hour | 10.3 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Treatment Failure | 3 hour | 13.1 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Treatment Failure | 4 hour | 16.6 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Treatment Failure | 5 hour | 18.3 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Treatment Failure | 6 hour | 21.7 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Treatment Failure | 7 hour | 25.7 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Treatment Failure | 9 hour | 42.3 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Treatment Failure | 10 hour | 48.6 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Treatment Failure | 11 hour | 55.4 percentage of participants |
| Ibuprofen 250 mg | Cumulative Percentage of Participants With Treatment Failure | 12 hour | 60.0 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Treatment Failure | 6 hour | 38.8 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Treatment Failure | 5 hour | 35.2 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Treatment Failure | 1.5 hour | 6.7 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Treatment Failure | 10 hour | 60.0 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Treatment Failure | 4 hour | 27.9 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Treatment Failure | 3 hour | 18.8 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Treatment Failure | 12 hour | 63.6 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Treatment Failure | 11 hour | 62.4 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Treatment Failure | 8 hour | 51.5 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Treatment Failure | 7 hour | 44.2 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Treatment Failure | 2 hour | 10.3 percentage of participants |
| Acetaminophen 650 mg | Cumulative Percentage of Participants With Treatment Failure | 9 hour | 56.4 percentage of participants |
Comparison: 1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-49.41, -23.71]Cochran-Mantel-Haenszel
Comparison: 1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.08695% CI: [-8.45, 0.56]Cochran-Mantel-Haenszel
Comparison: 1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.11295% CI: [-8.28, 0.86]Cochran-Mantel-Haenszel
Comparison: 1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-45.86, -19.17]Cochran-Mantel-Haenszel
Comparison: 1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-46.22, -19.55]Cochran-Mantel-Haenszel
Comparison: 1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.96895% CI: [-5.2, 5.42]Cochran-Mantel-Haenszel
Comparison: 2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-61.18, -34.58]Cochran-Mantel-Haenszel
Comparison: 2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.02395% CI: [-11.61, -0.84]Cochran-Mantel-Haenszel
Comparison: 2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.02695% CI: [-11.73, -0.73]Cochran-Mantel-Haenszel
Comparison: 2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-55.51, -27.52]Cochran-Mantel-Haenszel
Comparison: 2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-55.65, -27.89]Cochran-Mantel-Haenszel
Comparison: 2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.9695% CI: [-6.56, 6.23]Cochran-Mantel-Haenszel
Comparison: 3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-68.81, -42.65]Cochran-Mantel-Haenszel
Comparison: 3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.05595% CI: [-12.46, 0.13]Cochran-Mantel-Haenszel
Comparison: 3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.00195% CI: [-18.7, -4.7]Cochran-Mantel-Haenszel
Comparison: 3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-63.21, -35.6]Cochran-Mantel-Haenszel
Comparison: 3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-58.04, -30.55]Cochran-Mantel-Haenszel
Comparison: 3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.15195% CI: [-13.46, 2.08]Cochran-Mantel-Haenszel
Comparison: 4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-69.96, -43.91]Cochran-Mantel-Haenszel
Comparison: 4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.0195% CI: [-15.8, -2.19]Cochran-Mantel-Haenszel
Comparison: 4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-27.97, -12.24]Cochran-Mantel-Haenszel
Comparison: 4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-61.64, -33.83]Cochran-Mantel-Haenszel
Comparison: 4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-50.96, -23.4]Cochran-Mantel-Haenszel
Comparison: 4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.01395% CI: [-20.02, -2.36]Cochran-Mantel-Haenszel
Comparison: 5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-71.03, -45.26]Cochran-Mantel-Haenszel
Comparison: 5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.00595% CI: [-17.24, -3.06]Cochran-Mantel-Haenszel
Comparison: 5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-35.1, -18.44]Cochran-Mantel-Haenszel
Comparison: 5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-61.76, -33.72]Cochran-Mantel-Haenszel
Comparison: 5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-45.61, -17.76]Cochran-Mantel-Haenszel
Comparison: 5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-26.1, -7.42]Cochran-Mantel-Haenszel
Comparison: 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-70.44, -44.72]Cochran-Mantel-Haenszel
Comparison: 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.00495% CI: [-18.99, -3.57]Cochran-Mantel-Haenszel
Comparison: 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-36.77, -19.35]Cochran-Mantel-Haenszel
Comparison: 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-59.98, -32.04]Cochran-Mantel-Haenszel
Comparison: 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-43.65, -15.75]Cochran-Mantel-Haenszel
Comparison: 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-26.59, -7.29]Cochran-Mantel-Haenszel
Comparison: 7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-66.06, -39.75]Cochran-Mantel-Haenszel
Comparison: 7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.04295% CI: [-17.53, -0.34]Cochran-Mantel-Haenszel
Comparison: 7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-36.65, -17.86]Cochran-Mantel-Haenszel
Comparison: 7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-57.83, -29.72]Cochran-Mantel-Haenszel
Comparison: 7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-39.93, -11.57]Cochran-Mantel-Haenszel
Comparison: 7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-28.39, -8.59]Cochran-Mantel-Haenszel
Comparison: 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-58.96, -31.58]Cochran-Mantel-Haenszel
Comparison: 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.06495% CI: [-18.27, 0.5]Cochran-Mantel-Haenszel
Comparison: 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-36.91, -17.05]Cochran-Mantel-Haenszel
Comparison: 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-50.45, -22.07]Cochran-Mantel-Haenszel
Comparison: 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.0195% CI: [-32.64, -4.52]Cochran-Mantel-Haenszel
Comparison: 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-28.44, -7.9]Cochran-Mantel-Haenszel
Comparison: 9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-48.21, -20.21]Cochran-Mantel-Haenszel
Comparison: 9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.17995% CI: [-17.12, 3.19]Cochran-Mantel-Haenszel
Comparison: 9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-31.04, -10.35]Cochran-Mantel-Haenszel
Comparison: 9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: <0.00195% CI: [-41.44, -12.96]Cochran-Mantel-Haenszel
Comparison: 9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.05195% CI: [-27.84, 0.04]Cochran-Mantel-Haenszel
Comparison: 9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.0195% CI: [-24.21, -3.31]Cochran-Mantel-Haenszel
Comparison: 10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.00195% CI: [-37.31, -9.2]Cochran-Mantel-Haenszel
Comparison: 10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.67695% CI: [-12.63, 8.19]Cochran-Mantel-Haenszel
Comparison: 10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.01395% CI: [-23.57, -2.74]Cochran-Mantel-Haenszel
Comparison: 10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.00495% CI: [-35.18, -6.69]Cochran-Mantel-Haenszel
Comparison: 10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.1495% CI: [-24.19, 3.4]Cochran-Mantel-Haenszel
Comparison: 10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.03895% CI: [-21.51, -0.61]Cochran-Mantel-Haenszel
Comparison: 11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scoresp-value: 0.01395% CI: [-32.13, -3.79]Cochran-Mantel-Haenszel
Comparison: 11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.46795% CI: [-14.23, 6.53]Cochran-Mantel-Haenszel
Comparison: 11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.04995% CI: [-20.73, -0.02]Cochran-Mantel-Haenszel
Comparison: 11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.0595% CI: [-28.22, 0.02]Cochran-Mantel-Haenszel
Comparison: 11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scoresp-value: 0.25595% CI: [-21.73, 5.76]Cochran-Mantel-Haenszel
Comparison: 11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.21295% CI: [-16.89, 3.75]Cochran-Mantel-Haenszel
Comparison: 12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scoresp-value: 0.02795% CI: [-29.59, -1.77]Cochran-Mantel-Haenszel
Comparison: 12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.39995% CI: [-14.59, 5.82]Cochran-Mantel-Haenszel
Comparison: 12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.15295% CI: [-17.76, 2.77]Cochran-Mantel-Haenszel
Comparison: 12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.10695% CI: [-25.05, 2.4]Cochran-Mantel-Haenszel
Comparison: 12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.2195% CI: [-22, 4.83]Cochran-Mantel-Haenszel
Comparison: 12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.p-value: 0.54595% CI: [-13.26, 7]Cochran-Mantel-Haenszel
Other Pre-specified
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: FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 0.25 hour | 0.0 units on a scale | Standard Deviation 0.9 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 9 hour | 0.6 units on a scale | Standard Deviation 2.8 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 6 hour | 0.7 units on a scale | Standard Deviation 3 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 1 hour | 0.2 units on a scale | Standard Deviation 1.6 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 7 hour | 0.6 units on a scale | Standard Deviation 3 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 8 hour | 0.6 units on a scale | Standard Deviation 2.9 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 1.5 hour | 0.1 units on a scale | Standard Deviation 1.8 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 0.5 hour | 0.2 units on a scale | Standard Deviation 1.2 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 11 hour | 0.7 units on a scale | Standard Deviation 2.9 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 2 hour | 0.2 units on a scale | Standard Deviation 2.1 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 3 hour | 0.6 units on a scale | Standard Deviation 2.6 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 10 hour | 0.7 units on a scale | Standard Deviation 2.9 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 4 hour | 0.6 units on a scale | Standard Deviation 2.7 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 12 hour | 0.7 units on a scale | Standard Deviation 2.9 |
| Placebo | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 5 hour | 0.7 units on a scale | Standard Deviation 2.9 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 5 hour | 5.0 units on a scale | Standard Deviation 2.9 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 9 hour | 2.4 units on a scale | Standard Deviation 3.2 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 2 hour | 5.1 units on a scale | Standard Deviation 2.7 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 6 hour | 4.4 units on a scale | Standard Deviation 3 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 0.5 hour | 2.2 units on a scale | Standard Deviation 2.2 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 8 hour | 3.1 units on a scale | Standard Deviation 3.3 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 10 hour | 2.0 units on a scale | Standard Deviation 3.1 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 7 hour | 3.8 units on a scale | Standard Deviation 3.3 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 1 hour | 4.1 units on a scale | Standard Deviation 2.6 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 4 hour | 5.2 units on a scale | Standard Deviation 2.8 |
| 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 2.9 |
| 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 3 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 3 hour | 5.3 units on a scale | Standard Deviation 2.7 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 1.5 hour | 4.8 units on a scale | Standard Deviation 2.7 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 0.25 hour | 0.6 units on a scale | Standard Deviation 1.2 |
| Ibuprofen 250 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 5 hour | 4.2 units on a scale | Standard Deviation 3.1 |
| Ibuprofen 250 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 0.25 hour | 0.5 units on a scale | Standard Deviation 1.2 |
| Ibuprofen 250 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 0.5 hour | 1.8 units on a scale | Standard Deviation 2 |
| Ibuprofen 250 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 1 hour | 3.3 units on a scale | Standard Deviation 2.6 |
| Ibuprofen 250 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 1.5 hour | 3.9 units on a scale | Standard Deviation 2.8 |
| Ibuprofen 250 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 2 hour | 4.3 units on a scale | Standard Deviation 3 |
| Ibuprofen 250 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 3 hour | 4.5 units on a scale | Standard Deviation 3.1 |
| Ibuprofen 250 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 4 hour | 4.3 units on a scale | Standard Deviation 3 |
| Ibuprofen 250 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 6 hour | 3.8 units on a scale | Standard Deviation 3.1 |
| Ibuprofen 250 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 7 hour | 3.1 units on a scale | Standard Deviation 3.1 |
| Ibuprofen 250 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 8 hour | 2.6 units on a scale | Standard Deviation 3 |
| Ibuprofen 250 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 9 hour | 2.3 units on a scale | Standard Deviation 3 |
| Ibuprofen 250 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 10 hour | 1.9 units on a scale | Standard Deviation 2.9 |
| Ibuprofen 250 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 11 hour | 1.6 units on a scale | Standard Deviation 2.9 |
| Ibuprofen 250 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 12 hour | 1.6 units on a scale | Standard Deviation 2.9 |
| Acetaminophen 650 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 4 hour | 2.7 units on a scale | Standard Deviation 3.1 |
| Acetaminophen 650 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 0.5 hour | 2.0 units on a scale | Standard Deviation 2 |
| Acetaminophen 650 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 9 hour | 1.4 units on a scale | Standard Deviation 2.9 |
| Acetaminophen 650 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 3 hour | 2.9 units on a scale | Standard Deviation 2.9 |
| Acetaminophen 650 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 2 hour | 3.3 units on a scale | Standard Deviation 2.7 |
| Acetaminophen 650 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 0.25 hour | 0.7 units on a scale | Standard Deviation 1.3 |
| Acetaminophen 650 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 10 hour | 1.4 units on a scale | Standard Deviation 3 |
| Acetaminophen 650 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 1.5 hour | 3.4 units on a scale | Standard Deviation 2.6 |
| Acetaminophen 650 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 1 hour | 3.3 units on a scale | Standard Deviation 2.4 |
| Acetaminophen 650 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 12 hour | 1.2 units on a scale | Standard Deviation 2.8 |
| Acetaminophen 650 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 7 hour | 1.8 units on a scale | Standard Deviation 3 |
| Acetaminophen 650 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 6 hour | 2.2 units on a scale | Standard Deviation 3.1 |
| Acetaminophen 650 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 11 hour | 1.3 units on a scale | Standard Deviation 2.9 |
| Acetaminophen 650 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 8 hour | 1.6 units on a scale | Standard Deviation 3 |
| Acetaminophen 650 mg | Pain Intensity Difference on 11-Point Numerical Scale (PID11) | 5 hour | 2.6 units on a scale | Standard Deviation 3.1 |
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.00195% CI: [0.23, 0.96]ANCOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.29795% CI: [-0.12, 0.39]ANCOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.45795% CI: [-0.35, 0.16]ANCOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.01295% CI: [0.1, 0.82]ANCOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [0.33, 1.06]ANCOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.07695% CI: [-0.49, 0.02]ANCOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [1.42, 2.63]ANCOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.01695% CI: [0.1, 0.93]ANCOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.3395% CI: [-0.21, 0.64]ANCOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [0.91, 2.11]ANCOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [1.21, 2.42]ANCOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.16395% CI: [-0.73, 0.12]ANCOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [3.18, 4.65]ANCOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.00195% CI: [0.35, 1.38]ANCOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.00395% CI: [0.26, 1.31]ANCOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [2.32, 3.79]ANCOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [2.39, 3.87]ANCOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.76995% CI: [-0.6, 0.44]ANCOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [3.88, 5.42]ANCOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.00295% CI: [0.32, 1.4]ANCOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [0.83, 1.93]ANCOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [3.02, 4.56]ANCOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [2.49, 4.04]ANCOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.06295% CI: [-0.03, 1.06]ANCOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [4.01, 5.64]ANCOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.00995% CI: [0.19, 1.33]ANCOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [1.17, 2.33]ANCOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [3.25, 4.88]ANCOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [2.26, 3.9]ANCOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [0.41, 1.56]ANCOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [3.82, 5.52]ANCOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.0195% CI: [0.19, 1.38]ANCOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [1.81, 3.01]ANCOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [3.04, 4.74]ANCOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [1.4, 3.11]ANCOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [1.02, 2.23]ANCOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [3.65, 5.4]ANCOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.00995% CI: [0.21, 1.43]ANCOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [1.79, 3.04]ANCOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [2.83, 4.58]ANCOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [1.23, 2.99]ANCOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [0.97, 2.22]ANCOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [3.37, 5.17]ANCOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.01295% CI: [0.18, 1.44]ANCOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [1.72, 3]ANCOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [2.57, 4.36]ANCOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [1, 2.82]ANCOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [0.92, 2.19]ANCOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [2.76, 4.6]ANCOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.05595% CI: [-0.01, 1.27]ANCOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [1.54, 2.84]ANCOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [2.14, 3.97]ANCOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.00295% CI: [0.57, 2.42]ANCOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [0.91, 2.21]ANCOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [2.17, 4.03]ANCOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.04995% CI: [0, 1.3]ANCOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [1.27, 2.59]ANCOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [1.52, 3.37]ANCOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.01595% CI: [0.23, 2.1]ANCOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [0.62, 1.94]ANCOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [1.56, 3.4]ANCOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.08795% CI: [-0.08, 1.2]ANCOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [0.82, 2.12]ANCOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [1, 2.84]ANCOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.03295% CI: [0.09, 1.94]ANCOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.00695% CI: [0.26, 1.56]ANCOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [0.85, 2.66]ANCOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.66995% CI: [-0.49, 0.77]ANCOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.00795% CI: [0.24, 1.53]ANCOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [0.71, 2.52]ANCOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.06395% CI: [-0.05, 1.78]ANCOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.02295% CI: [0.11, 1.39]ANCOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.00895% CI: [0.32, 2.12]ANCOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.87695% CI: [-0.58, 0.68]ANCOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.13495% CI: [-0.15, 1.13]ANCOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.01195% CI: [0.27, 2.07]ANCOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.11295% CI: [-0.17, 1.64]ANCOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.17995% CI: [-0.2, 1.08]ANCOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.03295% CI: [0.09, 1.85]ANCOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.8595% CI: [-0.56, 0.67]ANCOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.31195% CI: [-0.3, 0.95]ANCOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.04395% CI: [0.03, 1.79]ANCOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.15495% CI: [-0.24, 1.53]ANCOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.40895% CI: [-0.36, 0.89]ANCOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.06595% CI: [-0.05, 1.68]ANCOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.86295% CI: [-0.66, 0.55]ANCOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.35295% CI: [-0.32, 0.9]ANCOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.04995% CI: [0, 1.73]ANCOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.23995% CI: [-0.35, 1.39]ANCOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.2795% CI: [-0.27, 0.96]ANCOVA
Other Pre-specified
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: FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 11 hour | 0.13 units on a scale | Standard Deviation 0.85 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 5 hour | 0.14 units on a scale | Standard Deviation 0.88 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 4 hour | 0.16 units on a scale | Standard Deviation 0.87 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 2 hour | 0.05 units on a scale | Standard Deviation 0.75 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 10 hour | 0.13 units on a scale | Standard Deviation 0.85 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 3 hour | 0.16 units on a scale | Standard Deviation 0.83 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 0.5 hour | 0.05 units on a scale | Standard Deviation 0.4 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 0.25 hour | 0.00 units on a scale | Standard Deviation 0.27 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 9 hour | 0.11 units on a scale | Standard Deviation 0.82 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 8 hour | 0.11 units on a scale | Standard Deviation 0.82 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 1 hour | 0.04 units on a scale | Standard Deviation 0.54 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 12 hour | 0.13 units on a scale | Standard Deviation 0.85 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 7 hour | 0.13 units on a scale | Standard Deviation 0.88 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 6 hour | 0.16 units on a scale | Standard Deviation 0.93 |
| Placebo | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 1.5 hour | 0.00 units on a scale | Standard Deviation 0.57 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 0.5 hour | 0.60 units on a scale | Standard Deviation 0.74 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 0.25 hour | 0.15 units on a scale | Standard Deviation 0.47 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 9 hour | 0.69 units on a scale | Standard Deviation 1.06 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 1 hour | 1.18 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 | 1.36 units on a scale | Standard Deviation 0.89 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 2 hour | 1.47 units on a scale | Standard Deviation 0.96 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 3 hour | 1.55 units on a scale | Standard Deviation 0.93 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 4 hour | 1.15 units on a scale | Standard Deviation 0.96 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 5 hour | 1.44 units on a scale | Standard Deviation 1 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 6 hour | 1.27 units on a scale | Standard Deviation 1.04 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 7 hour | 1.04 units on a scale | Standard Deviation 1.09 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 8 hour | 0.88 units on a scale | Standard Deviation 1.07 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 10 hour | 0.52 units on a scale | Standard Deviation 1.02 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 11 hour | 0.45 units on a scale | Standard Deviation 0.97 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 12 hour | 0.38 units on a scale | Standard Deviation 0.92 |
| Ibuprofen 250 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 0.25 hour | 0.12 units on a scale | Standard Deviation 0.47 |
| Ibuprofen 250 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 0.5 hour | 0.46 units on a scale | Standard Deviation 0.72 |
| Ibuprofen 250 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 9 hour | 0.60 units on a scale | Standard Deviation 0.95 |
| Ibuprofen 250 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 1 hour | 0.89 units on a scale | Standard Deviation 0.95 |
| Ibuprofen 250 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 11 hour | 0.40 units on a scale | Standard Deviation 0.93 |
| Ibuprofen 250 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 7 hour | 0.83 units on a scale | Standard Deviation 1.02 |
| Ibuprofen 250 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 5 hour | 1.13 units on a scale | Standard Deviation 1.05 |
| Ibuprofen 250 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 2 hour | 1.22 units on a scale | Standard Deviation 1.09 |
| Ibuprofen 250 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 10 hour | 0.50 units on a scale | Standard Deviation 0.95 |
| Ibuprofen 250 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 3 hour | 1.25 units on a scale | Standard Deviation 1.09 |
| Ibuprofen 250 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 12 hour | 0.39 units on a scale | Standard Deviation 0.96 |
| Ibuprofen 250 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 6 hour | 1.02 units on a scale | Standard Deviation 1.04 |
| Ibuprofen 250 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 8 hour | 0.67 units on a scale | Standard Deviation 0.97 |
| Ibuprofen 250 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 4 hour | 1.21 units on a scale | Standard Deviation 1.08 |
| Ibuprofen 250 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 1.5 hour | 1.09 units on a scale | Standard Deviation 1.01 |
| Acetaminophen 650 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 4 hour | 0.74 units on a scale | Standard Deviation 0.94 |
| Acetaminophen 650 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 5 hour | 0.75 units on a scale | Standard Deviation 0.95 |
| Acetaminophen 650 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 1 hour | 0.98 units on a scale | Standard Deviation 0.86 |
| Acetaminophen 650 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 6 hour | 0.63 units on a scale | Standard Deviation 0.97 |
| Acetaminophen 650 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 7 hour | 0.50 units on a scale | Standard Deviation 0.97 |
| Acetaminophen 650 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 0.5 hour | 0.61 units on a scale | Standard Deviation 0.73 |
| Acetaminophen 650 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 11 hour | 0.32 units on a scale | Standard Deviation 0.87 |
| Acetaminophen 650 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 8 hour | 0.45 units on a scale | Standard Deviation 0.92 |
| Acetaminophen 650 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 9 hour | 0.36 units on a scale | Standard Deviation 0.88 |
| Acetaminophen 650 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 0.25 hour | 0.20 units on a scale | Standard Deviation 0.51 |
| Acetaminophen 650 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 12 hour | 0.27 units on a scale | Standard Deviation 0.85 |
| Acetaminophen 650 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 2 hour | 0.92 units on a scale | Standard Deviation 0.9 |
| Acetaminophen 650 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 3 hour | 0.81 units on a scale | Standard Deviation 0.93 |
| Acetaminophen 650 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 1.5 hour | 0.98 units on a scale | Standard Deviation 0.86 |
| Acetaminophen 650 mg | Pain Intensity Difference on 4-Point Categorical Scale (PID4) | 10 hour | 0.37 units on a scale | Standard Deviation 0.91 |
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.03195% CI: [0.01, 0.28]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.52795% CI: [-0.06, 0.12]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.38695% CI: [-0.14, 0.05]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.08495% CI: [-0.02, 0.25]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00695% CI: [0.06, 0.32]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.13595% CI: [-0.17, 0.02]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.34, 0.73]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.06295% CI: [-0.01, 0.27]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.97795% CI: [-0.14, 0.14]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.21, 0.6]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.34, 0.73]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.06995% CI: [-0.27, 0.01]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.9, 1.38]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.12, 0.46]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.01195% CI: [0.05, 0.39]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.61, 1.09]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.67, 1.16]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.42795% CI: [-0.24, 0.1]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.11, 1.6]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00295% CI: [0.1, 0.44]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.23, 0.58]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.84, 1.33]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.7, 1.2]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.12395% CI: [-0.04, 0.31]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.14, 1.67]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.01295% CI: [0.05, 0.42]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.38, 0.75]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.9, 1.43]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.57, 1.11]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.14, 0.51]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.11, 1.65]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00295% CI: [0.11, 0.48]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.56, 0.95]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.82, 1.36]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.35, 0.9]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.27, 0.65]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.06, 1.61]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00395% CI: [0.1, 0.49]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.58, 0.98]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.76, 1.32]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.28, 0.84]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.29, 0.68]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1, 1.57]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00395% CI: [0.1, 0.5]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.51, 0.91]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.7, 1.27]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.29, 0.86]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.21, 0.61]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.81, 1.38]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.01495% CI: [0.05, 0.45]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.45, 0.86]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.56, 1.13]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00395% CI: [0.15, 0.73]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.21, 0.61]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.62, 1.2]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.04195% CI: [0.01, 0.42]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.35, 0.76]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.41, 0.99]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.01895% CI: [0.06, 0.65]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00195% CI: [0.14, 0.55]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.48, 1.05]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.04595% CI: [0, 0.4]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.24, 0.64]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.28, 0.84]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.02795% CI: [0.04, 0.61]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.0295% CI: [0.04, 0.44]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.29, 0.85]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.37495% CI: [-0.11, 0.28]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.14, 0.54]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.2, 0.76]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.10695% CI: [-0.05, 0.51]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.01395% CI: [0.05, 0.45]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00695% CI: [0.11, 0.67]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.79695% CI: [-0.17, 0.22]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.10495% CI: [-0.03, 0.36]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.0195% CI: [0.09, 0.65]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.11495% CI: [-0.05, 0.51]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.16895% CI: [-0.06, 0.34]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.02295% CI: [0.05, 0.59]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.6295% CI: [-0.14, 0.24]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.16495% CI: [-0.06, 0.33]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.05295% CI: [0, 0.54]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.19695% CI: [-0.09, 0.45]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.36495% CI: [-0.1, 0.28]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.07195% CI: [-0.02, 0.52]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.86595% CI: [-0.2, 0.17]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.23895% CI: [-0.08, 0.3]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.05495% CI: [0, 0.53]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.33595% CI: [-0.14, 0.4]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.17695% CI: [-0.06, 0.32]ANOVA
Other Pre-specified
Pain Relief Rating (PRR) Score
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: FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Pain Relief Rating (PRR) Score | 0.25 hour | 0.18 units on a scale | Standard Deviation 0.39 |
| Placebo | Pain Relief Rating (PRR) Score | 9 hour | 0.73 units on a scale | Standard Deviation 1.23 |
| Placebo | Pain Relief Rating (PRR) Score | 6 hour | 0.80 units on a scale | Standard Deviation 1.31 |
| Placebo | Pain Relief Rating (PRR) Score | 1 hour | 0.44 units on a scale | Standard Deviation 0.63 |
| Placebo | Pain Relief Rating (PRR) Score | 7 hour | 0.77 units on a scale | Standard Deviation 1.31 |
| Placebo | Pain Relief Rating (PRR) Score | 8 hour | 0.73 units on a scale | Standard Deviation 1.24 |
| Placebo | Pain Relief Rating (PRR) Score | 1.5 hour | 0.48 units on a scale | Standard Deviation 0.74 |
| Placebo | Pain Relief Rating (PRR) Score | 0.5 hour | 0.30 units on a scale | Standard Deviation 0.46 |
| Placebo | Pain Relief Rating (PRR) Score | 11 hour | 0.78 units on a scale | Standard Deviation 1.29 |
| Placebo | Pain Relief Rating (PRR) Score | 2 hour | 0.55 units on a scale | Standard Deviation 0.96 |
| Placebo | Pain Relief Rating (PRR) Score | 3 hour | 0.70 units on a scale | Standard Deviation 1.09 |
| Placebo | Pain Relief Rating (PRR) Score | 10 hour | 0.75 units on a scale | Standard Deviation 1.24 |
| Placebo | Pain Relief Rating (PRR) Score | 4 hour | 0.71 units on a scale | Standard Deviation 1.16 |
| Placebo | Pain Relief Rating (PRR) Score | 12 hour | 0.75 units on a scale | Standard Deviation 1.25 |
| Placebo | Pain Relief Rating (PRR) Score | 5 hour | 0.73 units on a scale | Standard Deviation 1.21 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating (PRR) Score | 5 hour | 2.64 units on a scale | Standard Deviation 1.27 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating (PRR) Score | 9 hour | 1.41 units on a scale | Standard Deviation 1.49 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating (PRR) Score | 2 hour | 2.65 units on a scale | Standard Deviation 1.21 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating (PRR) Score | 6 hour | 2.36 units on a scale | Standard Deviation 1.37 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating (PRR) Score | 0.5 hour | 1.29 units on a scale | Standard Deviation 1.02 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating (PRR) Score | 8 hour | 1.75 units on a scale | Standard Deviation 1.47 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating (PRR) Score | 10 hour | 1.20 units on a scale | Standard Deviation 1.47 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating (PRR) Score | 7 hour | 2.04 units on a scale | Standard Deviation 1.45 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating (PRR) Score | 1 hour | 2.19 units on a scale | Standard Deviation 1.22 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating (PRR) Score | 4 hour | 2.71 units on a scale | Standard Deviation 1.23 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating (PRR) Score | 12 hour | 0.97 units on a scale | Standard Deviation 1.35 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating (PRR) Score | 11 hour | 1.06 units on a scale | Standard Deviation 1.43 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating (PRR) Score | 3 hour | 2.75 units on a scale | Standard Deviation 1.17 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating (PRR) Score | 1.5 hour | 2.47 units on a scale | Standard Deviation 1.17 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Pain Relief Rating (PRR) Score | 0.25 hour | 0.51 units on a scale | Standard Deviation 0.65 |
| Ibuprofen 250 mg | Pain Relief Rating (PRR) Score | 5 hour | 2.18 units on a scale | Standard Deviation 1.37 |
| Ibuprofen 250 mg | Pain Relief Rating (PRR) Score | 0.25 hour | 0.36 units on a scale | Standard Deviation 0.61 |
| Ibuprofen 250 mg | Pain Relief Rating (PRR) Score | 0.5 hour | 1.11 units on a scale | Standard Deviation 0.97 |
| Ibuprofen 250 mg | Pain Relief Rating (PRR) Score | 1 hour | 1.85 units on a scale | Standard Deviation 1.18 |
| Ibuprofen 250 mg | Pain Relief Rating (PRR) Score | 1.5 hour | 2.08 units on a scale | Standard Deviation 1.25 |
| Ibuprofen 250 mg | Pain Relief Rating (PRR) Score | 2 hour | 2.28 units on a scale | Standard Deviation 1.33 |
| Ibuprofen 250 mg | Pain Relief Rating (PRR) Score | 3 hour | 2.35 units on a scale | Standard Deviation 1.36 |
| Ibuprofen 250 mg | Pain Relief Rating (PRR) Score | 4 hour | 2.27 units on a scale | Standard Deviation 1.39 |
| Ibuprofen 250 mg | Pain Relief Rating (PRR) Score | 6 hour | 2.01 units on a scale | Standard Deviation 1.42 |
| Ibuprofen 250 mg | Pain Relief Rating (PRR) Score | 7 hour | 1.68 units on a scale | Standard Deviation 1.43 |
| Ibuprofen 250 mg | Pain Relief Rating (PRR) Score | 8 hour | 1.40 units on a scale | Standard Deviation 1.41 |
| Ibuprofen 250 mg | Pain Relief Rating (PRR) Score | 9 hour | 1.31 units on a scale | Standard Deviation 1.45 |
| Ibuprofen 250 mg | Pain Relief Rating (PRR) Score | 10 hour | 1.19 units on a scale | Standard Deviation 1.43 |
| Ibuprofen 250 mg | Pain Relief Rating (PRR) Score | 11 hour | 1.03 units on a scale | Standard Deviation 1.4 |
| Ibuprofen 250 mg | Pain Relief Rating (PRR) Score | 12 hour | 0.97 units on a scale | Standard Deviation 1.4 |
| Acetaminophen 650 mg | Pain Relief Rating (PRR) Score | 4 hour | 1.55 units on a scale | Standard Deviation 1.39 |
| Acetaminophen 650 mg | Pain Relief Rating (PRR) Score | 0.5 hour | 1.20 units on a scale | Standard Deviation 1 |
| Acetaminophen 650 mg | Pain Relief Rating (PRR) Score | 9 hour | 0.95 units on a scale | Standard Deviation 1.31 |
| Acetaminophen 650 mg | Pain Relief Rating (PRR) Score | 3 hour | 1.66 units on a scale | Standard Deviation 1.36 |
| Acetaminophen 650 mg | Pain Relief Rating (PRR) Score | 2 hour | 1.86 units on a scale | Standard Deviation 1.25 |
| Acetaminophen 650 mg | Pain Relief Rating (PRR) Score | 0.25 hour | 0.50 units on a scale | Standard Deviation 0.7 |
| Acetaminophen 650 mg | Pain Relief Rating (PRR) Score | 10 hour | 0.95 units on a scale | Standard Deviation 1.37 |
| Acetaminophen 650 mg | Pain Relief Rating (PRR) Score | 1.5 hour | 1.90 units on a scale | Standard Deviation 1.19 |
| Acetaminophen 650 mg | Pain Relief Rating (PRR) Score | 1 hour | 1.86 units on a scale | Standard Deviation 1.14 |
| Acetaminophen 650 mg | Pain Relief Rating (PRR) Score | 12 hour | 0.85 units on a scale | Standard Deviation 1.35 |
| Acetaminophen 650 mg | Pain Relief Rating (PRR) Score | 7 hour | 1.14 units on a scale | Standard Deviation 1.39 |
| Acetaminophen 650 mg | Pain Relief Rating (PRR) Score | 6 hour | 1.29 units on a scale | Standard Deviation 1.43 |
| Acetaminophen 650 mg | Pain Relief Rating (PRR) Score | 11 hour | 0.88 units on a scale | Standard Deviation 1.34 |
| Acetaminophen 650 mg | Pain Relief Rating (PRR) Score | 8 hour | 1.03 units on a scale | Standard Deviation 1.37 |
| Acetaminophen 650 mg | Pain Relief Rating (PRR) Score | 5 hour | 1.50 units on a scale | Standard Deviation 1.43 |
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.14, 0.52]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.03495% CI: [0.01, 0.28]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.96395% CI: [-0.13, 0.14]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.06295% CI: [-0.01, 0.37]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00195% CI: [0.13, 0.52]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.0495% CI: [-0.28, -0.01]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.7, 1.27]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.09595% CI: [-0.03, 0.37]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.41495% CI: [-0.12, 0.29]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.52, 1.1]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.61, 1.19]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.40695% CI: [-0.29, 0.12]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.4, 2.09]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00695% CI: [0.1, 0.58]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00995% CI: [0.08, 0.57]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.07, 1.75]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.08, 1.77]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.90895% CI: [-0.26, 0.23]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.64, 2.35]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00295% CI: [0.15, 0.64]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.32, 0.82]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.25, 1.95]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.07, 1.78]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.15795% CI: [-0.07, 0.43]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.73, 2.48]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00595% CI: [0.11, 0.63]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.52, 1.05]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.36, 2.1]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.94, 1.69]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00295% CI: [0.15, 0.68]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.67, 2.45]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00495% CI: [0.13, 0.67]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.82, 1.37]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.27, 2.04]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.58, 1.36]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.42, 0.96]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.6, 2.4]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00295% CI: [0.16, 0.72]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.88, 1.44]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.16, 1.96]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.44, 1.24]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.44, 1]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.5, 2.31]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00195% CI: [0.18, 0.74]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.85, 1.43]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.04, 1.85]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.36, 1.17]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.39, 0.97]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.13, 1.98]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.01795% CI: [0.06, 0.65]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.77, 1.37]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.78, 1.62]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.02695% CI: [0.06, 0.91]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.42, 1.01]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.84, 1.69]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.01795% CI: [0.07, 0.66]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.6, 1.2]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.48, 1.33]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.08995% CI: [-0.06, 0.8]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.24, 0.83]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.6, 1.44]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.01895% CI: [0.06, 0.65]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.42, 1.02]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00295% CI: [0.25, 1.09]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.16395% CI: [-0.12, 0.72]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.01695% CI: [0.07, 0.66]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00295% CI: [0.26, 1.1]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.49695% CI: [-0.19, 0.4]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00395% CI: [0.16, 0.76]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00895% CI: [0.15, 1]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.31595% CI: [-0.21, 0.64]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.01995% CI: [0.06, 0.66]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.03895% CI: [0.02, 0.87]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.91895% CI: [-0.28, 0.31]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.10595% CI: [-0.05, 0.55]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.04595% CI: [0.01, 0.85]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.35595% CI: [-0.22, 0.62]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.12795% CI: [-0.07, 0.53]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.17195% CI: [-0.12, 0.7]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.7995% CI: [-0.25, 0.33]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.23595% CI: [-0.12, 0.47]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.23695% CI: [-0.16, 0.66]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.59995% CI: [-0.3, 0.53]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.35395% CI: [-0.15, 0.43]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.29395% CI: [-0.19, 0.62]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.98695% CI: [-0.28, 0.28]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.45995% CI: [-0.18, 0.39]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.28795% CI: [-0.18, 0.62]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.695% CI: [-0.3, 0.51]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.44795% CI: [-0.17, 0.4]ANOVA
Other Pre-specified
Participant's 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: 0 to 12 hours post-dose
Population: FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Participant's Global Evaluation of Study Medication | 1.0 units on a scale | Standard Deviation 1.4 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Participant's Global Evaluation of Study Medication | 3.4 units on a scale | Standard Deviation 1.2 |
| Ibuprofen 250 mg | Participant's Global Evaluation of Study Medication | 3.0 units on a scale | Standard Deviation 1.4 |
| Acetaminophen 650 mg | Participant's Global Evaluation of Study Medication | 2.6 units on a scale | Standard Deviation 1.5 |
Comparison: p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.p-value: 0.003Cochran-Mantel-Haenszel
Comparison: p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.p-value: <0.001Cochran-Mantel-Haenszel
Comparison: p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.p-value: 0.004Cochran-Mantel-Haenszel
Comparison: p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.p-value: <0.001Cochran-Mantel-Haenszel
Comparison: p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.p-value: <0.001Cochran-Mantel-Haenszel
Comparison: p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.p-value: <0.001Cochran-Mantel-Haenszel
Other Pre-specified
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: FAS included all randomized participants who were dosed with the 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) | 2 hour | 0.6 units on a scale | Standard Deviation 1.6 |
| 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 1.2 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 10 hour | 0.9 units on a scale | Standard Deviation 2 |
| 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 |
| 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 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 8 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) | 6 hour | 1.0 units on a scale | Standard Deviation 2.2 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 5 hour | 0.9 units on a scale | Standard Deviation 2 |
| 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 2.1 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 0.25 hour | 0.2 units on a scale | Standard Deviation 0.5 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 7 hour | 0.9 units on a scale | Standard Deviation 2.1 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 4 hour | 0.9 units on a scale | Standard Deviation 1.9 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 3 hour | 0.9 units on a scale | Standard Deviation 1.8 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 0.5 hour | 0.4 units on a scale | Standard Deviation 0.7 |
| 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 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 0.5 hour | 1.9 units on a scale | Standard Deviation 1.7 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 9 hour | 2.1 units on a scale | Standard Deviation 2.5 |
| 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 2.4 |
| 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 |
| 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 2.3 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 1 hour | 3.4 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) | 12 hour | 1.3 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) | 1.5 hour | 3.8 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 | 4.1 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) | 3 hour | 4.3 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) | 4 hour | 4.2 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) | 5 hour | 4.1 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) | 6 hour | 3.6 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) | 7 hour | 3.1 units on a scale | Standard Deviation 2.5 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 8 hour | 2.6 units on a scale | Standard Deviation 2.5 |
| Ibuprofen 250 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 1.5 hour | 3.2 units on a scale | Standard Deviation 2.2 |
| Ibuprofen 250 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 1.6 |
| Ibuprofen 250 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 8 hour | 2.1 units on a scale | Standard Deviation 2.3 |
| Ibuprofen 250 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 2 hour | 3.5 units on a scale | Standard Deviation 2.4 |
| Ibuprofen 250 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 7 hour | 2.5 units on a scale | Standard Deviation 2.4 |
| Ibuprofen 250 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 3 hour | 3.6 units on a scale | Standard Deviation 2.4 |
| Ibuprofen 250 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 0.25 hour | 0.5 units on a scale | Standard Deviation 1 |
| Ibuprofen 250 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 4 hour | 3.5 units on a scale | Standard Deviation 2.4 |
| Ibuprofen 250 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 9 hour | 1.9 units on a scale | Standard Deviation 2.3 |
| Ibuprofen 250 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 5 hour | 3.3 units on a scale | Standard Deviation 2.4 |
| Ibuprofen 250 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 250 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 6 hour | 3.0 units on a scale | Standard Deviation 2.4 |
| Ibuprofen 250 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 1 hour | 2.7 units on a scale | Standard Deviation 2 |
| Ibuprofen 250 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 250 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 12 hour | 1.4 units on a scale | Standard Deviation 2.3 |
| Acetaminophen 650 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 1 hour | 2.8 units on a scale | Standard Deviation 1.9 |
| Acetaminophen 650 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 1.5 hour | 2.9 units on a scale | Standard Deviation 1.9 |
| Acetaminophen 650 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 0.5 hour | 1.8 units on a scale | Standard Deviation 1.6 |
| Acetaminophen 650 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 5 hour | 2.2 units on a scale | Standard Deviation 2.3 |
| Acetaminophen 650 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 6 hour | 1.9 units on a scale | Standard Deviation 2.3 |
| Acetaminophen 650 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 2 hour | 2.8 units on a scale | Standard Deviation 2.1 |
| Acetaminophen 650 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 |
| Acetaminophen 650 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 8 hour | 1.5 units on a scale | Standard Deviation 2.2 |
| Acetaminophen 650 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 11 hour | 1.2 units on a scale | Standard Deviation 2.1 |
| Acetaminophen 650 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 3 hour | 2.5 units on a scale | Standard Deviation 2.2 |
| Acetaminophen 650 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 9 hour | 1.3 units on a scale | Standard Deviation 2.1 |
| Acetaminophen 650 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 7 hour | 1.6 units on a scale | Standard Deviation 2.3 |
| Acetaminophen 650 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 2.1 |
| Acetaminophen 650 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 4 hour | 2.3 units on a scale | Standard Deviation 2.3 |
| Acetaminophen 650 mg | Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) | 10 hour | 1.3 units on a scale | Standard Deviation 2.2 |
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00295% CI: [0.18, 0.77]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.09895% CI: [-0.03, 0.38]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.71995% CI: [-0.25, 0.17]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.04895% CI: [0, 0.6]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.21, 0.81]ANOVA
Comparison: 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.04695% CI: [-0.42, 0]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.05, 1.99]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.06995% CI: [-0.02, 0.63]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.60495% CI: [-0.24, 0.42]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.75, 1.69]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.96, 1.9]ANOVA
Comparison: 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.295% CI: [-0.54, 0.11]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [2.32, 3.46]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00295% CI: [0.23, 1.03]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00895% CI: [0.14, 0.95]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.69, 2.83]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.77, 2.91]ANOVA
Comparison: 1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.68595% CI: [-0.49, 0.32]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [2.77, 3.93]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00195% CI: [0.26, 1.07]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.57, 1.39]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [2.11, 3.27]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.79, 2.96]ANOVA
Comparison: 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.13295% CI: [-0.1, 0.73]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [2.88, 4.13]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00795% CI: [0.17, 1.05]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.91, 1.8]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [2.27, 3.52]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.52, 2.79]ANOVA
Comparison: 2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00195% CI: [0.3, 1.19]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [2.79, 4.09]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00395% CI: [0.24, 1.15]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.39, 2.31]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [2.1, 3.39]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.94, 2.24]ANOVA
Comparison: 3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.69, 1.61]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [2.67, 4]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00295% CI: [0.27, 1.2]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.47, 2.41]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.93, 3.26]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.73, 2.07]ANOVA
Comparison: 4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.73, 1.67]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [2.51, 3.87]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00295% CI: [0.29, 1.23]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.37, 2.33]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.75, 3.11]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.66, 2.03]ANOVA
Comparison: 5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.61, 1.56]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.95, 3.35]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.01595% CI: [0.12, 1.09]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.24, 2.22]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.35, 2.74]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.0195% CI: [0.22, 1.62]ANOVA
Comparison: 6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.63, 1.61]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.47, 2.88]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.02295% CI: [0.08, 1.06]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.95, 1.95]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.9, 2.3]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.04595% CI: [0.02, 1.43]ANOVA
Comparison: 7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.38, 1.38]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.09, 2.47]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.02495% CI: [0.07, 1.04]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.67, 1.65]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.54, 1.92]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.07995% CI: [-0.07, 1.32]ANOVA
Comparison: 8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.01595% CI: [0.12, 1.09]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.56, 1.94]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.43895% CI: [-0.29, 0.67]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00195% CI: [0.31, 1.29]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00395% CI: [0.37, 1.75]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.20495% CI: [-0.25, 1.14]ANOVA
Comparison: 9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.01495% CI: [0.12, 1.1]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.01895% CI: [0.15, 1.53]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.86795% CI: [-0.44, 0.52]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.09995% CI: [-0.08, 0.9]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.02495% CI: [0.11, 1.49]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.22895% CI: [-0.27, 1.12]ANOVA
Comparison: 10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.13695% CI: [-0.12, 0.86]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.07895% CI: [-0.07, 1.28]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.71695% CI: [-0.38, 0.56]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.19795% CI: [-0.16, 0.79]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.13195% CI: [-0.15, 1.19]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.39995% CI: [-0.39, 0.97]ANOVA
Comparison: 11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.34995% CI: [-0.25, 0.7]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.16995% CI: [-0.2, 1.12]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.93795% CI: [-0.48, 0.44]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.35195% CI: [-0.25, 0.69]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.15195% CI: [-0.18, 1.14]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.47695% CI: [-0.42, 0.9]ANOVA
Comparison: 12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.3195% CI: [-0.22, 0.71]ANOVA
Other Pre-specified
Time to Confirmed Onset of First Perceptible Relief
Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labeled '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 to 12 hours post-dose
Population: FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment. Here, number of participants analyzed signifies those participants who had the event (first perceptiblre relief).
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Placebo | Time to Confirmed Onset of First Perceptible Relief | NA minutes | 95% Confidence Interval 8.8 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time to Confirmed Onset of First Perceptible Relief | 21.3 minutes | 95% Confidence Interval 9.2 |
| Ibuprofen 250 mg | Time to Confirmed Onset of First Perceptible Relief | 24.6 minutes | 95% Confidence Interval 8.9 |
| Acetaminophen 650 mg | Time to Confirmed Onset of First Perceptible Relief | 24.2 minutes | 95% Confidence Interval 8.8 |
Comparison: p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.p-value: <0.001Gehan-Wilcoxon test
Comparison: p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.p-value: 0.088Gehan-Wilcoxon test
Comparison: p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.p-value: 0.133Gehan-Wilcoxon test
Comparison: p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.p-value: <0.001Gehan-Wilcoxon test
Comparison: p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.p-value: <0.001Gehan-Wilcoxon test
Comparison: p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.p-value: 0.887Gehan-Wilcoxon test
Other Pre-specified
Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale (SPID11) From 0 to 2 Hours, 0 to 6 Hours and 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, -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) to 10 (best).
Time frame: 0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dose
Population: FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale (SPID11) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post-dose | 0 to 2 hours | 0.3 units on a scale | Standard Deviation 2.9 |
| Placebo | Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale (SPID11) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post-dose | 0 to 12 hours | 6.8 units on a scale | Standard Deviation 30 |
| Placebo | Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale (SPID11) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post-dose | 0 to 6 hours | 2.9 units on a scale | Standard Deviation 13.5 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale (SPID11) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post-dose | 0 to 2 hours | 7.7 units on a scale | Standard Deviation 4.4 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale (SPID11) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post-dose | 0 to 12 hours | 41.8 units on a scale | Standard Deviation 28.7 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale (SPID11) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post-dose | 0 to 6 hours | 27.5 units on a scale | Standard Deviation 14.4 |
| Ibuprofen 250 mg | Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale (SPID11) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post-dose | 0 to 6 hours | 23.1 units on a scale | Standard Deviation 15.6 |
| Ibuprofen 250 mg | Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale (SPID11) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post-dose | 0 to 2 hours | 6.3 units on a scale | Standard Deviation 4.6 |
| Ibuprofen 250 mg | Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale (SPID11) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post-dose | 0 to 12 hours | 36.3 units on a scale | Standard Deviation 29.3 |
| Acetaminophen 650 mg | Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale (SPID11) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post-dose | 0 to 2 hours | 5.7 units on a scale | Standard Deviation 4.1 |
| Acetaminophen 650 mg | Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale (SPID11) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post-dose | 0 to 12 hours | 24.7 units on a scale | Standard Deviation 29.5 |
| Acetaminophen 650 mg | Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale (SPID11) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post-dose | 0 to 6 hours | 16.0 units on a scale | Standard Deviation 14.9 |
Comparison: 0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [6.09, 8.61]ANCOVA
Comparison: 0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.00295% CI: [0.53, 2.28]ANCOVA
Comparison: 0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [1.09, 2.88]ANCOVA
Comparison: 0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [4.69, 7.2]ANCOVA
Comparison: 0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [4.1, 6.63]ANCOVA
Comparison: 0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.20395% CI: [-0.31, 1.47]ANCOVA
Comparison: 0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [20.1, 28.9]ANCOVA
Comparison: 0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.00595% CI: [1.37, 7.52]ANCOVA
Comparison: 0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [8.23, 14.48]ANCOVA
Comparison: 0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [15.66, 24.45]ANCOVA
Comparison: 0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [8.71, 17.57]ANCOVA
Comparison: 0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [3.8, 10.04]ANCOVA
Comparison: 0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [26.09, 43.57]ANCOVA
Comparison: 0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: 0.0695% CI: [-0.25, 11.95]ANCOVA
Comparison: 0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [10.54, 22.95]ANCOVA
Comparison: 0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [20.26, 37.71]ANCOVA
Comparison: 0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [9.29, 26.88]ANCOVA
Comparison: 0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.p-value: <0.00195% CI: [4.7, 17.1]ANCOVA
Other Pre-specified
Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 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 and -3 (worst score) to 9 (best score) for SPID 6-8. 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, 6 to 8 hours post-dose
Population: FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose | 0 to 12 hours | 1.4 units on a scale | Standard Deviation 9 |
| Placebo | Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose | 0 to 6 hours | 0.7 units on a scale | Standard Deviation 4.2 |
| Placebo | Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose | 6 to 8 hours | 0.4 units on a scale | Standard Deviation 2.6 |
| Placebo | Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose | 0 to 8 hours | 0.9 units on a scale | Standard Deviation 5.8 |
| Placebo | Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose | 0 to 2 hours | 0.1 units on a scale | Standard Deviation 0.9 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose | 0 to 8 hours | 9.9 units on a scale | Standard Deviation 6.6 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose | 0 to 12 hours | 11.9 units on a scale | Standard Deviation 9.6 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose | 6 to 8 hours | 3.2 units on a scale | Standard Deviation 3 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose | 0 to 6 hours | 8.0 units on a scale | Standard Deviation 4.9 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose | 0 to 2 hours | 2.2 units on a scale | Standard Deviation 1.5 |
| Ibuprofen 250 mg | Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose | 0 to 8 hours | 7.9 units on a scale | Standard Deviation 7.1 |
| Ibuprofen 250 mg | Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose | 0 to 2 hours | 1.7 units on a scale | Standard Deviation 1.7 |
| Ibuprofen 250 mg | Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose | 0 to 6 hours | 6.4 units on a scale | Standard Deviation 5.5 |
| Ibuprofen 250 mg | Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose | 0 to 12 hours | 9.8 units on a scale | Standard Deviation 9.9 |
| Ibuprofen 250 mg | Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose | 6 to 8 hours | 2.5 units on a scale | Standard Deviation 2.9 |
| Acetaminophen 650 mg | Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose | 0 to 12 hours | 6.8 units on a scale | Standard Deviation 9 |
| Acetaminophen 650 mg | Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose | 0 to 6 hours | 4.6 units on a scale | Standard Deviation 4.7 |
| Acetaminophen 650 mg | Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose | 0 to 2 hours | 1.6 units on a scale | Standard Deviation 1.4 |
| Acetaminophen 650 mg | Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose | 0 to 8 hours | 5.5 units on a scale | Standard Deviation 6.2 |
| Acetaminophen 650 mg | Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose | 6 to 8 hours | 1.6 units on a scale | Standard Deviation 2.7 |
Comparison: 0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.72, 2.51]ANOVA
Comparison: 0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00295% CI: [0.16, 0.71]ANOVA
Comparison: 0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.3, 0.86]ANOVA
Comparison: 0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.29, 2.08]ANOVA
Comparison: 0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.14, 1.93]ANOVA
Comparison: 0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.30395% CI: [-0.13, 0.43]ANOVA
Comparison: 0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [5.86, 8.58]ANOVA
Comparison: 0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00195% CI: [0.63, 2.53]ANOVA
Comparison: 0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [2.52, 4.45]ANOVA
Comparison: 0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [4.28, 6.99]ANOVA
Comparison: 0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [2.37, 5.1]ANOVA
Comparison: 0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.95, 2.86]ANOVA
Comparison: 0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [7.08, 10.71]ANOVA
Comparison: 0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00295% CI: [0.73, 3.26]ANOVA
Comparison: 0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [3.2, 5.77]ANOVA
Comparison: 0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [5.08, 8.71]ANOVA
Comparison: 0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [2.58, 6.24]ANOVA
Comparison: 0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.21, 3.77]ANOVA
Comparison: 0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [7.76, 13.08]ANOVA
Comparison: 0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.02495% CI: [0.28, 4]ANOVA
Comparison: 0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [3.35, 7.12]ANOVA
Comparison: 0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [5.62, 10.93]ANOVA
Comparison: 0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [2.51, 7.86]ANOVA
Comparison: 0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00195% CI: [1.22, 4.97]ANOVA
Comparison: 6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.95, 3.59]ANOVA
Comparison: 6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.02395% CI: [0.09, 1.24]ANOVA
Comparison: 6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.07, 2.24]ANOVA
Comparison: 6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.29, 2.92]ANOVA
Comparison: 6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00895% CI: [0.29, 1.94]ANOVA
Comparison: 6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.41, 1.57]ANOVA
Other Pre-specified
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 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, -8 (worst score) to 56 (best score) for SPRID 0-8, -12 (worst score) to 84 (best score) for SPRID 0-12 and -3 (worst score) to 21 (best score) for SPRID 6-8 hours. 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 8 hours, 0 to 12, 6 to 8 hours post-dose
Population: FAS included all randomized participants who were dosed with the 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 Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose | 0 to 12 hours | 9.7 units on a scale | Standard Deviation 20.5 |
| Placebo | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose | 0 to 6 hours | 4.5 units on a scale | Standard Deviation 9.3 |
| Placebo | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose | 6 to 8 hours | 2.7 units on a scale | Standard Deviation 6.1 |
| Placebo | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose | 0 to 8 hours | 6.2 units on a scale | Standard Deviation 13 |
| Placebo | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose | 0 to 2 hours | 0.9 units on a scale | Standard Deviation 2 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose | 0 to 8 hours | 28.2 units on a scale | Standard Deviation 14.5 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose | 0 to 12 hours | 34.9 units on a scale | Standard Deviation 21.5 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose | 6 to 8 hours | 9.3 units on a scale | Standard Deviation 6.9 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose | 0 to 6 hours | 22.5 units on a scale | Standard Deviation 10.7 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose | 0 to 2 hours | 6.3 units on a scale | Standard Deviation 3.3 |
| Ibuprofen 250 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose | 0 to 8 hours | 23.2 units on a scale | Standard Deviation 15.7 |
| Ibuprofen 250 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose | 0 to 2 hours | 5.2 units on a scale | Standard Deviation 3.5 |
| Ibuprofen 250 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose | 0 to 6 hours | 18.6 units on a scale | Standard Deviation 11.9 |
| Ibuprofen 250 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose | 0 to 12 hours | 29.6 units on a scale | Standard Deviation 22.5 |
| Ibuprofen 250 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose | 6 to 8 hours | 7.6 units on a scale | Standard Deviation 6.7 |
| Acetaminophen 650 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose | 0 to 12 hours | 21.9 units on a scale | Standard Deviation 21.6 |
| Acetaminophen 650 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose | 0 to 6 hours | 13.8 units on a scale | Standard Deviation 11 |
| Acetaminophen 650 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose | 0 to 2 hours | 4.9 units on a scale | Standard Deviation 3.1 |
| Acetaminophen 650 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose | 0 to 8 hours | 16.9 units on a scale | Standard Deviation 14.8 |
| Acetaminophen 650 mg | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose | 6 to 8 hours | 5.0 units on a scale | Standard Deviation 6.6 |
Comparison: 0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [4.42, 6.32]ANOVA
Comparison: 0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00295% CI: [0.4, 1.74]ANOVA
Comparison: 0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.77, 2.13]ANOVA
Comparison: 0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [3.35, 5.25]ANOVA
Comparison: 0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [2.96, 4.88]ANOVA
Comparison: 0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.26895% CI: [-0.29, 1.05]ANOVA
Comparison: 0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [14.69, 21.28]ANOVA
Comparison: 0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.57, 6.17]ANOVA
Comparison: 0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [6.48, 11.15]ANOVA
Comparison: 0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [10.83, 17.4]ANOVA
Comparison: 0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [5.86, 12.48]ANOVA
Comparison: 0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [2.62, 7.27]ANOVA
Comparison: 0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [17.52, 26.37]ANOVA
Comparison: 0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00295% CI: [1.91, 8.09]ANOVA
Comparison: 0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [8.29, 14.56]ANOVA
Comparison: 0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [12.53, 21.36]ANOVA
Comparison: 0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [6.07, 14.97]ANOVA
Comparison: 0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [3.3, 9.55]ANOVA
Comparison: 0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [18.57, 31.63]ANOVA
Comparison: 0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.02395% CI: [0.74, 9.86]ANOVA
Comparison: 0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [8.55, 17.8]ANOVA
Comparison: 0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [13.28, 26.31]ANOVA
Comparison: 0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [5.36, 18.49]ANOVA
Comparison: 0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [3.27, 12.48]ANOVA
Comparison: 6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [4.61, 8.62]ANOVA
Comparison: 6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.01595% CI: [0.34, 3.14]ANOVA
Comparison: 6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [2.92, 5.76]ANOVA
Comparison: 6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [2.87, 6.88]ANOVA
Comparison: 6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.02895% CI: [0.25, 4.28]ANOVA
Comparison: 6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.19, 4.02]ANOVA
Other Pre-specified
Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post Dose
TOTPAR: Time-weighted sum of PRR scores over 2, 6 and 12 hours. TOTPAR total score range: 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 which ranges from 0 =no relief to 4 =complete relief.
Time frame: 0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dose
Population: FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post Dose | 0 to 2 hours | 0.9 units on a scale | Standard Deviation 1.2 |
| Placebo | Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post Dose | 0 to 12 hours | 8.3 units on a scale | Standard Deviation 12.7 |
| Placebo | Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post Dose | 0 to 6 hours | 3.8 units on a scale | Standard Deviation 5.6 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post Dose | 0 to 2 hours | 4.1 units on a scale | Standard Deviation 2 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post Dose | 0 to 12 hours | 23.0 units on a scale | Standard Deviation 12.7 |
| Ibuprofen 250 mg + Acetaminophen 500 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post Dose | 0 to 6 hours | 14.6 units on a scale | Standard Deviation 6.3 |
| Ibuprofen 250 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post Dose | 0 to 6 hours | 12.3 units on a scale | Standard Deviation 6.8 |
| Ibuprofen 250 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post Dose | 0 to 2 hours | 3.5 units on a scale | Standard Deviation 2 |
| Ibuprofen 250 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post Dose | 0 to 12 hours | 19.9 units on a scale | Standard Deviation 13.2 |
| Acetaminophen 650 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post Dose | 0 to 2 hours | 3.2 units on a scale | Standard Deviation 1.9 |
| Acetaminophen 650 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post Dose | 0 to 12 hours | 15.0 units on a scale | Standard Deviation 13.4 |
| Acetaminophen 650 mg | Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post Dose | 0 to 6 hours | 9.2 units on a scale | Standard Deviation 6.7 |
Comparison: 0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [2.68, 3.82]ANOVA
Comparison: 0-2 hour:Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00295% CI: [0.23, 1.03]ANOVA
Comparison: 0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [0.46, 1.27]ANOVA
Comparison: 0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [2.05, 3.19]ANOVA
Comparison: 0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.81, 2.96]ANOVA
Comparison: 0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.25895% CI: [-0.17, 0.64]ANOVA
Comparison: 0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [8.79, 12.74]ANOVA
Comparison: 0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.00195% CI: [0.91, 3.67]ANOVA
Comparison: 0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [3.93, 6.73]ANOVA
Comparison: 0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [6.51, 10.44]ANOVA
Comparison: 0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [3.46, 7.42]ANOVA
Comparison: 0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [1.65, 4.43]ANOVA
Comparison: 0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [10.74, 18.62]ANOVA
Comparison: 0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: 0.02495% CI: [0.41, 5.91]ANOVA
Comparison: 0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [5.15, 10.73]ANOVA
Comparison: 0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [7.59, 15.45]ANOVA
Comparison: 0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [2.79, 10.71]ANOVA
Comparison: 0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.p-value: <0.00195% CI: [2, 7.56]ANOVA