Pain
Conditions
Keywords
Pain following third molar extraction
Brief summary
This study will compare the pain relieving effect of a single-dose of a novel ibuprofen formulation to placebo and two formulations of standard ibuprofen in the treatment of post-surgical dental pain following wisdom tooth (third molar) removal.
Interventions
DRUGNovel Ibuprofen
Single-dose of novel ibuprofen (equal to 400 mg ibuprofen)
Single-dose of standard ibuprofen (400mg)
DRUGPlacebo
Single-dose 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
16 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Normal, healthy males and females 16 to 40 years of age * Outpatients who have moderate to severe post-operative pain (confirmed by a Visual Analog Scale-Pain Severity Rating \[VAS-PSR\] score of at least 50 mm on a 100 mm VAS-PSR) following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction * Use of only the following pre-operative medication(s)/anesthetic(s): topical benzocaine, a short acting parenteral (local) anesthetic (mepivacaine or lidocaine) with or without vasoconstrictor and/or nitrous oxide
Exclusion criteria
* Pregnancy or breast-feeding * Alcohol or substance abuse * Any serious medical or psychiatric disorder * History of stomach ulcers, stomach bleed, or other bleeding disorders * Use of a prescription or over-the-counter drug with which administration of ibuprofen or any other non-steroidal anti-inflammatory drug, acetaminophen, or hydrocodone is contraindicated (including: opioids, antipsychotics, antianxiety agents, or other central nervous system depressants\[including alcohol\])
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8) | 0 to 8 hours | SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 8 hours. SPRID 0-8 score range: -8 (worst) to 56 (best). PRID: sum of Pain intensity differences (PID) and pain relief rating (PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). PID score range: -1(worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief). |
| Time to Onset of Meaningful Relief | 0 to 8 hours | Participants evaluated the 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 8 hours after dosing or until stopped by the participant, or rescue medication was administered. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Difference (PID) | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours | PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 \[none\] to 3 \[severe\]) from the baseline score (Baseline pain severity score range 2 \[moderate\] to 3 \[severe\]). Total possible score range for PID: -1 (worst) to 3 (best). |
| Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours | PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 \[none\] to 3 \[severe\]) from the baseline score (Baseline pain severity score range 2 \[moderate\] to 3 \[severe\]). Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief). |
| Time-weighted Sum of Pain Intensity Difference (SPID) | 0-2, 0-3, 0-6, 0-8 hours | SPID: time-weighted sum of PID over 2, 3, 6 and 8 hours. SPID scores range was -2 (worst) to 6 (best) for SPID 0-2, -3 (worst) to 9 (best) for SPID 0-3, -6 (worst) to 18 (best) for SPID 0-6, -8 (worst) to 24 (best) for SPID 0-8. PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1(worst) to 3 (best). |
| Time-weighted Sum of Pain Relief Rating (TOTPAR) | 0-2, 0-3, 0-6, 0-8 hours | TOTPAR: time-weighted sum of PRR scores over 2, 3, 6 and 8 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2, 0 (worst) to 12 (best) for TOTPAR 0-3, 0 (worst) to 24 (best) for TOTPAR 0-6, 0 (worst) to 32 (best) for TOTPAR 0-8. PRR was evaluated at different time points during the study up to 8 hours, and immediately after taking rescue medication (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief. |
| Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) | 0-2, 0-3, 0-6, 0-8 hours | SPRID: time-weighted sum of PRID over 2, 3, 6 and 8 hours. SPRID score range:-2 (worst) to 14(best) for SPRID 0-2, -3(worst) to 21(best) for SPRID 0-3, -6(worst) to 42(best) for SPRID 0-6, -8(worst) to 56(best) for SPRID 0-8. PRID:sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID:baseline pain severity score minus pain severity score at given time(score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: scored on 5-point pain relief rating scale(0=No relief to 4=Complete relief). |
| Time to Confirmed First Perceptible Relief | 0 to 8 hours | Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief. |
| Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours | Percentage of participants with first perceptible relief was evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief. |
| Time to Treatment Failure | 0 to 8 hours | Median time of dropping out of the participants from the study due to lack of efficacy or rescue medication, whichever came first. |
| Cumulative Percentage of Participants With Treatment Failure | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours | Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication. |
| Cumulative Percentage of Participants With Complete Relief | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours | Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief. |
| Participant Global Evaluation of Study Medication | 8 hours | Participant global evaluation of study medication was performed at the 8-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 Meaningful Relief | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours | Percentage of participants with meaningful relief evaluated by stopping the stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered. |
| Pain Relief Rating (PRR) | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours | PRR was evaluated at different time points during the study up to 8 hours after taking the study medication, and immediately before rescue medication was taken (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Single oral dose of 2 placebo tablets. | 48 |
| Ibuprofen Sodium Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen. | 95 |
| Ibuprofen (Advil) Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen). | 86 |
| Ibuprofen (Motrin IB) Single oral dose of 2 ibuprofen \[Motrin ibuprofen (IB)\] 200 mg tablets (total dose of 400 mg ibuprofen). | 87 |
| Total | 316 |
Baseline characteristics
| Characteristic | Placebo | Ibuprofen Sodium | Ibuprofen (Advil) | Ibuprofen (Motrin IB) | Total |
|---|---|---|---|---|---|
| Age Continuous | 18.1 Years STANDARD_DEVIATION 1.6 | 18.6 Years STANDARD_DEVIATION 2.1 | 18.6 Years STANDARD_DEVIATION 2.3 | 18.4 Years STANDARD_DEVIATION 2 | 18.5 Years STANDARD_DEVIATION 2.1 |
| Number of Participants with Pain Severity Score Moderate | 27 Participants | 51 Participants | 43 Participants | 43 Participants | 164 Participants |
| Number of Participants with Pain Severity Score Severe | 21 Participants | 44 Participants | 43 Participants | 44 Participants | 152 Participants |
| Sex: Female, Male Female | 25 Participants | 48 Participants | 44 Participants | 44 Participants | 161 Participants |
| Sex: Female, Male Male | 23 Participants | 47 Participants | 42 Participants | 43 Participants | 155 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 | 8 / 48 | 10 / 95 | 12 / 86 | 10 / 87 |
| serious Total, serious adverse events | 0 / 48 | 0 / 95 | 0 / 86 | 0 / 87 |
Outcome results
Primary
Time to Onset of Meaningful Relief
Participants evaluated the 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 8 hours after dosing or until stopped by the participant, or rescue medication was administered.
Time frame: 0 to 8 hours
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Onset of Meaningful Relief | NA Minutes |
| Ibuprofen Sodium | Time to Onset of Meaningful Relief | 42.4 Minutes |
| Ibuprofen (Advil + Motrin IB) | Time to Onset of Meaningful Relief | 55.3 Minutes |
Comparison: Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error controlled at 5% significance level (2-sided) by testing primary endpoints sequentially: IBU Na vs. Placebo for SPRID 0-8 then TMR, IBU Na vs. IBU (Advil and Motrin IB) for TMR. If comparison at preceding step was significant only then subsequent comparisons were significant.p-value: <0.00195% CI: [6.78, 24.15]Proportional hazards model
Comparison: HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. Type I error controlled at 5% significance level (2-sided) by testing primary endpoints sequentially: IBU Na vs. Placebo for SPRID 0-8 then TMR, IBU Na vs. IBU (Advil and Motrin IB) for TMR. If comparison at preceding step was significant only then subsequent comparisons were significant.p-value: <0.00195% CI: [1.22, 2.06]Proportional hazards model
Primary
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8)
SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 8 hours. SPRID 0-8 score range: -8 (worst) to 56 (best). PRID: sum of Pain intensity differences (PID) and pain relief rating (PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). PID score range: -1(worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).
Time frame: 0 to 8 hours
Population: Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8) | 5.4 Units on a scale | Standard Deviation 14.1 |
| Ibuprofen Sodium | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8) | 29.8 Units on a scale | Standard Deviation 14.2 |
Comparison: Treatment difference (Ibuprofen sodium - placebo) and 95 percent (%) confidence interval (CI):based on LS means from analysis of variance(ANOVA). Type I error controlled at 5% significance level (2-sided) by testing primary endpoints sequentially: Ibuprofen sodium (IBU Na) versus(vs.) Placebo for SPRID 0-8 then time to meaningful relief(TMR), IBU Na vs. IBU (Advil and Motrin IB) for TMR. If comparison at preceding step was significant only then subsequent comparisons were significant.p-value: <0.00195% CI: [19.32, 29.09]ANOVA
Secondary
Cumulative Percentage of Participants With Complete Relief
Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.
Time frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Cumulative Percentage of Participants With Complete Relief | 1.5 hours | 0.0 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Complete Relief | 5 hours | 6.3 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Complete Relief | 6 hours | 6.3 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Complete Relief | 2 hours | 0.0 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Complete Relief | 1 hour | 0.0 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Complete Relief | 8 hours | 6.3 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Complete Relief | 3 hours | 0.0 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Complete Relief | 0.5 hours | 0.0 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Complete Relief | 0.25 hours | 0.0 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Complete Relief | 4 hours | 6.3 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Complete Relief | 7 hours | 6.3 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Complete Relief | 4 hours | 54.7 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Complete Relief | 5 hours | 54.7 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Complete Relief | 7 hours | 54.7 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Complete Relief | 0.5 hours | 6.3 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Complete Relief | 8 hours | 54.7 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Complete Relief | 1 hour | 27.4 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Complete Relief | 1.5 hours | 41.1 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Complete Relief | 2 hours | 48.4 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Complete Relief | 6 hours | 54.7 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Complete Relief | 3 hours | 52.6 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Complete Relief | 0.25 hours | 0.0 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Complete Relief | 8 hours | 64.2 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Complete Relief | 0.25 hours | 0.0 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Complete Relief | 1 hour | 20.8 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Complete Relief | 1.5 hours | 32.4 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Complete Relief | 2 hours | 43.9 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Complete Relief | 3 hours | 54.9 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Complete Relief | 4 hours | 61.8 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Complete Relief | 5 hours | 63.0 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Complete Relief | 6 hours | 63.6 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Complete Relief | 7 hours | 64.2 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Complete Relief | 0.5 hours | 3.5 Percentage of participants |
Comparison: 0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.07895% CI: [1.34, 11.34]Cochran-Mantel-Haenszel
Comparison: 0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.30395% CI: [-3.01, 8.49]Cochran-Mantel-Haenszel
Comparison: 1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [18.14, 36.34]Cochran-Mantel-Haenszel
Comparison: 1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.21795% CI: [-4.31, 17.63]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [31.2, 51.12]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.14995% CI: [-3.33, 21.04]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [38.49, 58.73]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.47795% CI: [-8.03, 17.13]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [42.63, 62.99]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.73995% CI: [-14.77, 10.5]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [36.29, 60.77]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.2895% CI: [-19.24, 5.65]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [36.29, 60.77]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.20295% CI: [-20.44, 4.41]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [36.29, 60.77]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.1795% CI: [-21.02, 3.8]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [36.29, 60.77]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.1495% CI: [-21.62, 3.16]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [36.29, 60.77]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.1495% CI: [-21.62, 3.16]Cochran-Mantel-Haenszel
Secondary
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
Percentage of participants with first perceptible relief was evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief.
Time frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 1 hour | 20.8 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 7 hours | 22.9 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 3 hours | 22.9 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 1.5 hours | 22.9 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 0.25 hours | 6.3 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 2 hours | 22.9 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 5 hours | 22.9 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 6 hours | 22.9 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 0.5 hours | 14.6 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 8 hours | 22.9 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 4 hours | 22.9 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 4 hours | 95.8 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 8 hours | 95.8 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 0.25 hours | 26.3 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 0.5 hours | 84.2 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 1 hour | 94.7 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 1.5 hours | 95.8 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 2 hours | 95.8 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 3 hours | 95.8 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 5 hours | 95.8 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 6 hours | 95.8 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 7 hours | 95.8 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 3 hours | 88.4 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 0.5 hours | 60.7 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 4 hours | 88.4 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 5 hours | 88.4 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 0.25 hours | 12.1 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 7 hours | 88.4 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 1.5 hours | 87.3 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 6 hours | 88.4 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 2 hours | 87.9 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 1 hour | 84.4 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Confirmed First Perceptible Relief | 8 hours | 88.4 Percentage of participants |
Comparison: 0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.00495% CI: [8.79, 31.24]Cochran-Mantel-Haenszel
Comparison: 0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.00395% CI: [4.26, 24.43]Cochran-Mantel-Haenszel
Comparison: 0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [57.67, 81.4]Cochran-Mantel-Haenszel
Comparison: 0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [13.16, 33.75]Cochran-Mantel-Haenszel
Comparison: 1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [62.77, 84.67]Cochran-Mantel-Haenszel
Comparison: 1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.01495% CI: [3.21, 17.08]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [61.05, 84.17]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.02895% CI: [2.02, 14.68]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [61.05, 84.17]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.03695% CI: [1.54, 14.08]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [61.05, 84.17]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.04795% CI: [1.07, 13.48]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [61.05, 84.17]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.04795% CI: [1.07, 13.48]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [61.05, 84.17]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.04795% CI: [1.07, 13.48]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [61.05, 84.17]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.04795% CI: [1.07, 13.48]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [61.05, 84.17]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.04795% CI: [1.07, 13.48]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [61.05, 84.17]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.04795% CI: [1.07, 13.48]Cochran-Mantel-Haenszel
Secondary
Cumulative Percentage of Participants With Meaningful Relief
Percentage of participants with meaningful relief evaluated by stopping the stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered.
Time frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 0.5 hours | 4.2 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 5 hours | 20.8 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 2 hours | 18.8 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 0.25 hours | 0.0 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 4 hours | 20.8 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 3 hours | 20.8 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 7 hours | 20.8 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 1 hour | 12.5 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 8 hours | 22.9 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 6 hours | 20.8 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Meaningful Relief | 1.5 hours | 14.6 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Meaningful Relief | 7 hours | 95.8 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Meaningful Relief | 0.25 hours | 1.1 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Meaningful Relief | 0.5 hours | 28.4 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Meaningful Relief | 1 hour | 73.7 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Meaningful Relief | 1.5 hours | 87.4 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Meaningful Relief | 2 hours | 91.6 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Meaningful Relief | 3 hours | 94.7 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Meaningful Relief | 4 hours | 94.7 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Meaningful Relief | 5 hours | 94.7 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Meaningful Relief | 6 hours | 94.7 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Meaningful Relief | 8 hours | 95.8 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Meaningful Relief | 1.5 hours | 69.9 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Meaningful Relief | 0.25 hours | 0.6 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Meaningful Relief | 5 hours | 87.9 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Meaningful Relief | 1 hour | 52.6 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Meaningful Relief | 8 hours | 88.4 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Meaningful Relief | 6 hours | 87.9 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Meaningful Relief | 0.5 hours | 16.8 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Meaningful Relief | 3 hours | 86.7 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Meaningful Relief | 2 hours | 79.8 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Meaningful Relief | 7 hours | 87.9 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Meaningful Relief | 4 hours | 87.9 Percentage of participants |
Comparison: 0.25 hours-Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.p-value: 0.4995% CI: [-0.97, 3]Cochran-Mantel-Haenszel
Comparison: 0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.62395% CI: [-1.88, 2.95]Cochran-Mantel-Haenszel
Comparison: 0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [13.51, 35.22]Cochran-Mantel-Haenszel
Comparison: 0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.02395% CI: [1.15, 22.48]Cochran-Mantel-Haenszel
Comparison: 1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [48.99, 73.7]Cochran-Mantel-Haenszel
Comparison: 1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [9.58, 32.92]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [61.59, 83.71]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.00195% CI: [7.83, 27.06]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [61.14, 84.11]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.01395% CI: [3.47, 19.93]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [61.83, 85.33]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.04195% CI: [1.27, 14.75]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [61.83, 85.33]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.07395% CI: [0.23, 13.36]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [61.83, 85.33]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.07395% CI: [0.23, 13.36]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [61.83, 85.33]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.07395% CI: [0.23, 13.36]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [63.14, 86.27]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.03595% CI: [1.57, 14.1]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [61.05, 84.17]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.04795% CI: [1.07, 13.48]Cochran-Mantel-Haenszel
Secondary
Cumulative Percentage of Participants With Treatment Failure
Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.
Time frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 5 hours | 70.8 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 6 hours | 72.9 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 7 hours | 77.1 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 1 hour | 0.0 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 8 hours | 79.2 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 0.25 hours | 0.0 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 1.5 hours | 25.0 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 2 hours | 54.2 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 4 hours | 70.8 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 3 hours | 70.8 Percentage of participants |
| Placebo | Cumulative Percentage of Participants With Treatment Failure | 0.5 hours | 0.0 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Treatment Failure | 2 hours | 2.1 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Treatment Failure | 0.5 hours | 0.0 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Treatment Failure | 3 hours | 4.2 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Treatment Failure | 6 hours | 13.7 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Treatment Failure | 4 hours | 9.5 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Treatment Failure | 1.5 hours | 1.1 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Treatment Failure | 7 hours | 20.0 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Treatment Failure | 0.25 hours | 0.0 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Treatment Failure | 5 hours | 10.5 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Treatment Failure | 8 hours | 26.3 Percentage of participants |
| Ibuprofen Sodium | Cumulative Percentage of Participants With Treatment Failure | 1 hour | 0.0 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Treatment Failure | 8 hours | 20.2 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Treatment Failure | 0.25 hours | 0.0 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Treatment Failure | 0.5 hours | 0.0 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Treatment Failure | 1 hour | 0.0 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Treatment Failure | 1.5 hours | 2.3 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Treatment Failure | 2 hours | 5.8 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Treatment Failure | 4 hours | 8.1 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Treatment Failure | 5 hours | 10.4 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Treatment Failure | 6 hours | 12.1 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Treatment Failure | 7 hours | 16.2 Percentage of participants |
| Ibuprofen (Advil + Motrin IB) | Cumulative Percentage of Participants With Treatment Failure | 3 hours | 8.1 Percentage of participants |
Comparison: 1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-36.67, -11.2]Cochran-Mantel-Haenszel
Comparison: 1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.48395% CI: [-4.12, 1.7]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-65.63, -38.22]Cochran-Mantel-Haenszel
Comparison: 2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.17495% CI: [-7.97, 0.75]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-79.8, -53.35]Cochran-Mantel-Haenszel
Comparison: 3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.2495% CI: [-9.38, 1.89]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-75.21, -47.5]Cochran-Mantel-Haenszel
Comparison: 4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.66895% CI: [-5.47, 8.52]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-74.28, -46.34]Cochran-Mantel-Haenszel
Comparison: 5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.9895% CI: [-7.44, 7.63]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-73.05, -45.5]Cochran-Mantel-Haenszel
Comparison: 6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.71195% CI: [-6.68, 9.81]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-70.84, -42.85]Cochran-Mantel-Haenszel
Comparison: 7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.44595% CI: [-5.94, 13.38]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: <0.00195% CI: [-66.77, -38.81]Cochran-Mantel-Haenszel
Comparison: 8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.p-value: 0.25695% CI: [-4.75, 16.84]Cochran-Mantel-Haenszel
Secondary
Pain Intensity Difference (PID)
PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 \[none\] to 3 \[severe\]) from the baseline score (Baseline pain severity score range 2 \[moderate\] to 3 \[severe\]). Total possible score range for PID: -1 (worst) to 3 (best).
Time frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Pain Intensity Difference (PID) | 5 hours | 0.0 Units on a scale | Standard Deviation 1 |
| Placebo | Pain Intensity Difference (PID) | 2 hours | 0.0 Units on a scale | Standard Deviation 0.9 |
| Placebo | Pain Intensity Difference (PID) | 7 hours | -0.0 Units on a scale | Standard Deviation 0.9 |
| Placebo | Pain Intensity Difference (PID) | 4 hours | 0.1 Units on a scale | Standard Deviation 1 |
| Placebo | Pain Intensity Difference (PID) | 3 hours | 0.0 Units on a scale | Standard Deviation 0.9 |
| Placebo | Pain Intensity Difference (PID) | 0.25 hours | 0.0 Units on a scale | Standard Deviation 0.4 |
| Placebo | Pain Intensity Difference (PID) | 1 hour | 0.0 Units on a scale | Standard Deviation 0.7 |
| Placebo | Pain Intensity Difference (PID) | 0.5 hours | 0.0 Units on a scale | Standard Deviation 0.5 |
| Placebo | Pain Intensity Difference (PID) | 6 hours | -0.0 Units on a scale | Standard Deviation 0.9 |
| Placebo | Pain Intensity Difference (PID) | 1.5 hour | 0.0 Units on a scale | Standard Deviation 0.8 |
| Placebo | Pain Intensity Difference (PID) | 8 hours | -0.0 Units on a scale | Standard Deviation 0.8 |
| Ibuprofen Sodium | Pain Intensity Difference (PID) | 3 hours | 1.6 Units on a scale | Standard Deviation 0.9 |
| Ibuprofen Sodium | Pain Intensity Difference (PID) | 0.25 hours | 0.3 Units on a scale | Standard Deviation 0.5 |
| Ibuprofen Sodium | Pain Intensity Difference (PID) | 0.5 hours | 1.0 Units on a scale | Standard Deviation 0.7 |
| Ibuprofen Sodium | Pain Intensity Difference (PID) | 1 hour | 1.5 Units on a scale | Standard Deviation 0.9 |
| Ibuprofen Sodium | Pain Intensity Difference (PID) | 1.5 hour | 1.7 Units on a scale | Standard Deviation 0.9 |
| Ibuprofen Sodium | Pain Intensity Difference (PID) | 2 hours | 1.8 Units on a scale | Standard Deviation 0.9 |
| Ibuprofen Sodium | Pain Intensity Difference (PID) | 4 hours | 1.5 Units on a scale | Standard Deviation 0.9 |
| Ibuprofen Sodium | Pain Intensity Difference (PID) | 5 hours | 1.4 Units on a scale | Standard Deviation 1 |
| Ibuprofen Sodium | Pain Intensity Difference (PID) | 6 hours | 1.2 Units on a scale | Standard Deviation 1 |
| Ibuprofen Sodium | Pain Intensity Difference (PID) | 7 hours | 0.9 Units on a scale | Standard Deviation 1 |
| Ibuprofen Sodium | Pain Intensity Difference (PID) | 8 hours | 0.8 Units on a scale | Standard Deviation 1 |
| Ibuprofen (Advil + Motrin IB) | Pain Intensity Difference (PID) | 7 hours | 1.2 Units on a scale | Standard Deviation 1.1 |
| Ibuprofen (Advil + Motrin IB) | Pain Intensity Difference (PID) | 5 hours | 1.6 Units on a scale | Standard Deviation 1 |
| Ibuprofen (Advil + Motrin IB) | Pain Intensity Difference (PID) | 1 hour | 1.3 Units on a scale | Standard Deviation 0.9 |
| Ibuprofen (Advil + Motrin IB) | Pain Intensity Difference (PID) | 0.25 hours | 0.1 Units on a scale | Standard Deviation 0.5 |
| Ibuprofen (Advil + Motrin IB) | Pain Intensity Difference (PID) | 6 hours | 1.5 Units on a scale | Standard Deviation 1.1 |
| Ibuprofen (Advil + Motrin IB) | Pain Intensity Difference (PID) | 0.5 hours | 0.6 Units on a scale | Standard Deviation 0.8 |
| Ibuprofen (Advil + Motrin IB) | Pain Intensity Difference (PID) | 3 hours | 1.7 Units on a scale | Standard Deviation 1 |
| Ibuprofen (Advil + Motrin IB) | Pain Intensity Difference (PID) | 2 hours | 1.7 Units on a scale | Standard Deviation 0.9 |
| Ibuprofen (Advil + Motrin IB) | Pain Intensity Difference (PID) | 8 hours | 1.1 Units on a scale | Standard Deviation 1.1 |
| Ibuprofen (Advil + Motrin IB) | Pain Intensity Difference (PID) | 4 hours | 1.7 Units on a scale | Standard Deviation 1 |
| Ibuprofen (Advil + Motrin IB) | Pain Intensity Difference (PID) | 1.5 hour | 1.5 Units on a scale | Standard Deviation 0.9 |
Comparison: 0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [0.13, 0.46]ANOVA
Comparison: 0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [0.11, 0.34]ANOVA
Comparison: 0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [0.7, 1.19]ANOVA
Comparison: 0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [0.2, 0.55]ANOVA
Comparison: 1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [1.18, 1.75]ANOVA
Comparison: 1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.01795% CI: [0.04, 0.45]ANOVA
Comparison: 1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [1.39, 1.96]ANOVA
Comparison: 1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.01595% CI: [0.05, 0.46]ANOVA
Comparison: 2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [1.41, 1.98]ANOVA
Comparison: 2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.36295% CI: [-0.11, 0.3]ANOVA
Comparison: 3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [1.27, 1.86]ANOVA
Comparison: 3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.47295% CI: [-0.29, 0.14]ANOVA
Comparison: 4 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [1.07, 1.7]ANOVA
Comparison: 4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.13495% CI: [-0.4, 0.05]ANOVA
Comparison: 5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [1, 1.63]ANOVA
Comparison: 5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.13595% CI: [-0.4, 0.05]ANOVA
Comparison: 6 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [0.84, 1.5]ANOVA
Comparison: 6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.03695% CI: [-0.49, -0.02]ANOVA
Comparison: 7 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [0.61, 1.26]ANOVA
Comparison: 7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.06495% CI: [-0.46, 0.01]ANOVA
Comparison: 8 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [0.52, 1.18]ANOVA
Comparison: 8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.07495% CI: [-0.46, 0.02]ANOVA
Secondary
Pain Relief Rating (PRR)
PRR was evaluated at different time points during the study up to 8 hours after taking the study medication, and immediately before rescue medication was taken (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.
Time frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Pain Relief Rating (PRR) | 0.5 hours | 0.5 Units on a scale | Standard Deviation 0.7 |
| Placebo | Pain Relief Rating (PRR) | 5 hours | 0.7 Units on a scale | Standard Deviation 1.3 |
| Placebo | Pain Relief Rating (PRR) | 2 hours | 0.7 Units on a scale | Standard Deviation 1.2 |
| Placebo | Pain Relief Rating (PRR) | 0.25 hours | 0.4 Units on a scale | Standard Deviation 0.6 |
| Placebo | Pain Relief Rating (PRR) | 4 hours | 0.8 Units on a scale | Standard Deviation 1.3 |
| Placebo | Pain Relief Rating (PRR) | 3 hours | 0.7 Units on a scale | Standard Deviation 1.2 |
| Placebo | Pain Relief Rating (PRR) | 7 hours | 0.5 Units on a scale | Standard Deviation 1.1 |
| Placebo | Pain Relief Rating (PRR) | 1 hour | 0.6 Units on a scale | Standard Deviation 1 |
| Placebo | Pain Relief Rating (PRR) | 8 hours | 0.5 Units on a scale | Standard Deviation 1.1 |
| Placebo | Pain Relief Rating (PRR) | 6 hours | 0.7 Units on a scale | Standard Deviation 1.2 |
| Placebo | Pain Relief Rating (PRR) | 1.5 hours | 0.7 Units on a scale | Standard Deviation 1.1 |
| Ibuprofen Sodium | Pain Relief Rating (PRR) | 7 hours | 1.9 Units on a scale | Standard Deviation 1.4 |
| Ibuprofen Sodium | Pain Relief Rating (PRR) | 0.25 hours | 0.7 Units on a scale | Standard Deviation 0.8 |
| Ibuprofen Sodium | Pain Relief Rating (PRR) | 0.5 hours | 2.0 Units on a scale | Standard Deviation 1.1 |
| Ibuprofen Sodium | Pain Relief Rating (PRR) | 1 hour | 2.9 Units on a scale | Standard Deviation 1 |
| Ibuprofen Sodium | Pain Relief Rating (PRR) | 1.5 hours | 3.1 Units on a scale | Standard Deviation 1 |
| Ibuprofen Sodium | Pain Relief Rating (PRR) | 2 hours | 3.1 Units on a scale | Standard Deviation 1.1 |
| Ibuprofen Sodium | Pain Relief Rating (PRR) | 3 hours | 2.9 Units on a scale | Standard Deviation 1.2 |
| Ibuprofen Sodium | Pain Relief Rating (PRR) | 4 hours | 2.8 Units on a scale | Standard Deviation 1.2 |
| Ibuprofen Sodium | Pain Relief Rating (PRR) | 5 hours | 2.6 Units on a scale | Standard Deviation 1.3 |
| Ibuprofen Sodium | Pain Relief Rating (PRR) | 6 hours | 2.3 Units on a scale | Standard Deviation 1.4 |
| Ibuprofen Sodium | Pain Relief Rating (PRR) | 8 hours | 1.7 Units on a scale | Standard Deviation 1.4 |
| Ibuprofen (Advil + Motrin IB) | Pain Relief Rating (PRR) | 1.5 hours | 2.8 Units on a scale | Standard Deviation 1.2 |
| Ibuprofen (Advil + Motrin IB) | Pain Relief Rating (PRR) | 0.25 hours | 0.5 Units on a scale | Standard Deviation 0.7 |
| Ibuprofen (Advil + Motrin IB) | Pain Relief Rating (PRR) | 5 hours | 2.8 Units on a scale | Standard Deviation 1.3 |
| Ibuprofen (Advil + Motrin IB) | Pain Relief Rating (PRR) | 1 hour | 2.5 Units on a scale | Standard Deviation 1.1 |
| Ibuprofen (Advil + Motrin IB) | Pain Relief Rating (PRR) | 8 hours | 2.2 Units on a scale | Standard Deviation 1.5 |
| Ibuprofen (Advil + Motrin IB) | Pain Relief Rating (PRR) | 6 hours | 2.6 Units on a scale | Standard Deviation 1.4 |
| Ibuprofen (Advil + Motrin IB) | Pain Relief Rating (PRR) | 0.5 hours | 1.5 Units on a scale | Standard Deviation 1.1 |
| Ibuprofen (Advil + Motrin IB) | Pain Relief Rating (PRR) | 3 hours | 3.0 Units on a scale | Standard Deviation 1.2 |
| Ibuprofen (Advil + Motrin IB) | Pain Relief Rating (PRR) | 2 hours | 3.0 Units on a scale | Standard Deviation 1.2 |
| Ibuprofen (Advil + Motrin IB) | Pain Relief Rating (PRR) | 7 hours | 2.3 Units on a scale | Standard Deviation 1.5 |
| Ibuprofen (Advil + Motrin IB) | Pain Relief Rating (PRR) | 4 hours | 3.0 Units on a scale | Standard Deviation 1.2 |
Comparison: 0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: 0.00795% CI: [0.1, 0.6]ANOVA
Comparison: 0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: 0.0195% CI: [0.06, 0.42]ANOVA
Comparison: 0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95 % CI were calculated based on LS mean from the ANOVA model.p-value: <0.00195% CI: [1.1, 1.84]ANOVA
Comparison: 0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: <0.00195% CI: [0.27, 0.8]ANOVA
Comparison: 1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: <0.00195% CI: [1.84, 2.6]ANOVA
Comparison: 1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: 0.00695% CI: [0.12, 0.66]ANOVA
Comparison: 1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: <0.00195% CI: [2, 2.77]ANOVA
Comparison: 1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: 0.02295% CI: [0.05, 0.6]ANOVA
Comparison: 2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: <0.00195% CI: [2, 2.79]ANOVA
Comparison: 2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: 0.36995% CI: [-0.15, 0.41]ANOVA
Comparison: 3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: <0.00195% CI: [1.78, 2.6]ANOVA
Comparison: 3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: 0.4295% CI: [-0.42, 0.17]ANOVA
Comparison: 4 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: <0.00195% CI: [1.58, 2.45]ANOVA
Comparison: 4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: 0.15195% CI: [-0.54, 0.08]ANOVA
Comparison: 5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: <0.00195% CI: [1.43, 2.33]ANOVA
Comparison: 5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: 0.1695% CI: [-0.56, 0.09]ANOVA
Comparison: 6 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: <0.00195% CI: [1.16, 2.1]ANOVA
Comparison: 6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: 0.05595% CI: [-0.67, 0.01]ANOVA
Comparison: 7 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: <0.00195% CI: [0.91, 1.88]ANOVA
Comparison: 7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: 0.0495% CI: [-0.71, -0.02]ANOVA
Comparison: 8 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: <0.00195% CI: [0.71, 1.69]ANOVA
Comparison: 8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: 0.01595% CI: [-0.79, -0.08]ANOVA
Secondary
Participant Global Evaluation of Study Medication
Participant global evaluation of study medication was performed at the 8-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: 8 hours
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Participant Global Evaluation of Study Medication | 1.1 Units on a scale | Standard Deviation 1.3 |
| Ibuprofen Sodium | Participant Global Evaluation of Study Medication | 3.8 Units on a scale | Standard Deviation 1 |
| Ibuprofen (Advil + Motrin IB) | Participant Global Evaluation of Study Medication | 3.7 Units on a scale | Standard Deviation 1.2 |
Comparison: Treatment difference (Ibuprofen sodium - placebo) and the associated CI were calculated based on the weighted Gamma statistic.p-value: <0.00195% CI: [0.83, 0.98]Cochran-Mantel-Haenszel
Comparison: HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.p-value: 0.66795% CI: [-0.15, 0.24]Proportional hazards model
Secondary
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 \[none\] to 3 \[severe\]) from the baseline score (Baseline pain severity score range 2 \[moderate\] to 3 \[severe\]). Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).
Time frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 8 hours | 0.5 Units on a scale | Standard Deviation 1.8 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 0.25 hours | 0.4 Units on a scale | Standard Deviation 0.9 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 0.5 hours | 0.6 Units on a scale | Standard Deviation 1.2 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 1 hour | 0.7 Units on a scale | Standard Deviation 1.6 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 1.5 hours | 0.7 Units on a scale | Standard Deviation 1.8 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 2 hours | 0.8 Units on a scale | Standard Deviation 2 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 3 hours | 0.7 Units on a scale | Standard Deviation 2 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 4 hours | 0.9 Units on a scale | Standard Deviation 2.3 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 5 hours | 0.8 Units on a scale | Standard Deviation 2.1 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 6 hours | 0.6 Units on a scale | Standard Deviation 2 |
| Placebo | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 7 hours | 0.5 Units on a scale | Standard Deviation 1.9 |
| Ibuprofen Sodium | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 1.5 hours | 4.8 Units on a scale | Standard Deviation 1.8 |
| Ibuprofen Sodium | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 2 hours | 4.9 Units on a scale | Standard Deviation 1.8 |
| Ibuprofen Sodium | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 3 hours | 4.5 Units on a scale | Standard Deviation 2 |
| Ibuprofen Sodium | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 7 hours | 2.9 Units on a scale | Standard Deviation 2.3 |
| Ibuprofen Sodium | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 4 hours | 4.3 Units on a scale | Standard Deviation 2.1 |
| Ibuprofen Sodium | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 5 hours | 4.0 Units on a scale | Standard Deviation 2.2 |
| Ibuprofen Sodium | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 0.25 hours | 1.1 Units on a scale | Standard Deviation 1.2 |
| Ibuprofen Sodium | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 0.5 hours | 3.0 Units on a scale | Standard Deviation 1.7 |
| Ibuprofen Sodium | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 8 hours | 2.6 Units on a scale | Standard Deviation 2.3 |
| Ibuprofen Sodium | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 1 hour | 4.4 Units on a scale | Standard Deviation 1.8 |
| Ibuprofen Sodium | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 6 hours | 3.5 Units on a scale | Standard Deviation 2.2 |
| Ibuprofen (Advil + Motrin IB) | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 7 hours | 3.5 Units on a scale | Standard Deviation 2.5 |
| Ibuprofen (Advil + Motrin IB) | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 1.5 hours | 4.3 Units on a scale | Standard Deviation 2 |
| Ibuprofen (Advil + Motrin IB) | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 6 hours | 4.1 Units on a scale | Standard Deviation 2.4 |
| Ibuprofen (Advil + Motrin IB) | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 1 hour | 3.8 Units on a scale | Standard Deviation 2 |
| Ibuprofen (Advil + Motrin IB) | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 2 hours | 4.7 Units on a scale | Standard Deviation 2 |
| Ibuprofen (Advil + Motrin IB) | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 8 hours | 3.2 Units on a scale | Standard Deviation 2.5 |
| Ibuprofen (Advil + Motrin IB) | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 0.5 hours | 2.1 Units on a scale | Standard Deviation 1.8 |
| Ibuprofen (Advil + Motrin IB) | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 3 hours | 4.7 Units on a scale | Standard Deviation 2.1 |
| Ibuprofen (Advil + Motrin IB) | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 0.25 hours | 0.6 Units on a scale | Standard Deviation 1.1 |
| Ibuprofen (Advil + Motrin IB) | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 5 hours | 4.4 Units on a scale | Standard Deviation 2.2 |
| Ibuprofen (Advil + Motrin IB) | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | 4 hours | 4.8 Units on a scale | Standard Deviation 2.2 |
Comparison: 0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.00195% CI: [0.26, 1.04]ANOVA
Comparison: 0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.00195% CI: [0.18, 0.75]ANOVA
Comparison: 0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [1.82, 3.01]ANOVA
Comparison: 0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [0.48, 1.34]ANOVA
Comparison: 1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [3.03, 4.33]ANOVA
Comparison: 1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.00895% CI: [0.17, 1.11]ANOVA
Comparison: 1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [3.4, 4.72]ANOVA
Comparison: 1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.01795% CI: [0.1, 1.06]ANOVA
Comparison: 2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [3.42, 4.75]ANOVA
Comparison: 2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.35995% CI: [-0.26, 0.7]ANOVA
Comparison: 3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [3.06, 4.45]ANOVA
Comparison: 3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.43695% CI: [-0.7, 0.3]ANOVA
Comparison: 4 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [2.66, 4.14]ANOVA
Comparison: 4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.13995% CI: [-0.93, 0.13]ANOVA
Comparison: 5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [2.44, 3.95]ANOVA
Comparison: 5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.14495% CI: [-0.95, 0.14]ANOVA
Comparison: 6 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [2.01, 3.58]ANOVA
Comparison: 6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.04395% CI: [-1.15, -0.02]ANOVA
Comparison: 7 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [1.53, 3.12]ANOVA
Comparison: 7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.04495% CI: [-1.16, -0.02]ANOVA
Comparison: 8 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [1.25, 2.85]ANOVA
Comparison: 8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.02795% CI: [-1.23, -0.08]ANOVA
Secondary
Time to Confirmed First Perceptible Relief
Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief.
Time frame: 0 to 8 hours
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Confirmed First Perceptible Relief | NA Minutes |
| Ibuprofen Sodium | Time to Confirmed First Perceptible Relief | 16.4 Minutes |
| Ibuprofen (Advil + Motrin IB) | Time to Confirmed First Perceptible Relief | 25.7 Minutes |
Comparison: HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.p-value: <0.00195% CI: [6.51, 23.46]Proportional hazards model
Comparison: HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.p-value: <0.00195% CI: [1.38, 2.34]Proportional hazards model
Secondary
Time to Treatment Failure
Median time of dropping out of the participants from the study due to lack of efficacy or rescue medication, whichever came first.
Time frame: 0 to 8 hours
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Treatment Failure | 1.7 Hours |
| Ibuprofen Sodium | Time to Treatment Failure | NA Hours |
| Ibuprofen (Advil + Motrin IB) | Time to Treatment Failure | NA Hours |
Comparison: HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.p-value: <0.00195% CI: [0.08, 0.22]Proportional hazards model
Comparison: HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.p-value: 0.28195% CI: [0.79, 2.22]Proportional hazards model
Secondary
Time-weighted Sum of Pain Intensity Difference (SPID)
SPID: time-weighted sum of PID over 2, 3, 6 and 8 hours. SPID scores range was -2 (worst) to 6 (best) for SPID 0-2, -3 (worst) to 9 (best) for SPID 0-3, -6 (worst) to 18 (best) for SPID 0-6, -8 (worst) to 24 (best) for SPID 0-8. PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1(worst) to 3 (best).
Time frame: 0-2, 0-3, 0-6, 0-8 hours
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Time-weighted Sum of Pain Intensity Difference (SPID) | SPID 0-2 | 0.1 Units on a scale | Standard Deviation 1.3 |
| Placebo | Time-weighted Sum of Pain Intensity Difference (SPID) | SPID 0-3 | 0.1 Units on a scale | Standard Deviation 2.1 |
| Placebo | Time-weighted Sum of Pain Intensity Difference (SPID) | SPID 0-6 | 0.2 Units on a scale | Standard Deviation 4.8 |
| Placebo | Time-weighted Sum of Pain Intensity Difference (SPID) | SPID 0-8 | 0.1 Units on a scale | Standard Deviation 6.4 |
| Ibuprofen Sodium | Time-weighted Sum of Pain Intensity Difference (SPID) | SPID 0-8 | 10.2 Units on a scale | Standard Deviation 6.3 |
| Ibuprofen Sodium | Time-weighted Sum of Pain Intensity Difference (SPID) | SPID 0-2 | 2.8 Units on a scale | Standard Deviation 1.4 |
| Ibuprofen Sodium | Time-weighted Sum of Pain Intensity Difference (SPID) | SPID 0-6 | 8.5 Units on a scale | Standard Deviation 4.7 |
| Ibuprofen Sodium | Time-weighted Sum of Pain Intensity Difference (SPID) | SPID 0-3 | 4.4 Units on a scale | Standard Deviation 2.2 |
| Ibuprofen (Advil + Motrin IB) | Time-weighted Sum of Pain Intensity Difference (SPID) | SPID 0-8 | 11.1 Units on a scale | Standard Deviation 6.7 |
| Ibuprofen (Advil + Motrin IB) | Time-weighted Sum of Pain Intensity Difference (SPID) | SPID 0-3 | 4.1 Units on a scale | Standard Deviation 2.3 |
| Ibuprofen (Advil + Motrin IB) | Time-weighted Sum of Pain Intensity Difference (SPID) | SPID 0-6 | 8.9 Units on a scale | Standard Deviation 5 |
| Ibuprofen (Advil + Motrin IB) | Time-weighted Sum of Pain Intensity Difference (SPID) | SPID 0-2 | 2.4 Units on a scale | Standard Deviation 1.5 |
Comparison: SPID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [2.27, 3.18]ANOVA
Comparison: SPID 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.00795% CI: [0.12, 0.78]ANOVA
Comparison: SPID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [3.6, 4.98]ANOVA
Comparison: SPID 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.14495% CI: [-0.13, 0.87]ANOVA
Comparison: SPID 0-6: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [6.66, 9.66]ANOVA
Comparison: SPID 0-6: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.67995% CI: [-1.31, 0.85]ANOVA
Comparison: SPID 0-8: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [7.92, 11.96]ANOVA
Comparison: SPID 0-8: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.36795% CI: [-2.12, 0.79]ANOVA
Secondary
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)
SPRID: time-weighted sum of PRID over 2, 3, 6 and 8 hours. SPRID score range:-2 (worst) to 14(best) for SPRID 0-2, -3(worst) to 21(best) for SPRID 0-3, -6(worst) to 42(best) for SPRID 0-6, -8(worst) to 56(best) for SPRID 0-8. PRID:sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID:baseline pain severity score minus pain severity score at given time(score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: scored on 5-point pain relief rating scale(0=No relief to 4=Complete relief).
Time frame: 0-2, 0-3, 0-6, 0-8 hours
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) | SPRID 0-2 | 1.3 Units on a scale | Standard Deviation 2.9 |
| Placebo | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) | SPRID 0-3 | 2.1 Units on a scale | Standard Deviation 4.8 |
| Placebo | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) | SPRID 0-6 | 4.4 Units on a scale | Standard Deviation 10.8 |
| Placebo | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) | SPRID 0-8 | 5.4 Units on a scale | Standard Deviation 14.1 |
| Ibuprofen Sodium | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) | SPRID 0-8 | 29.8 Units on a scale | Standard Deviation 14.2 |
| Ibuprofen Sodium | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) | SPRID 0-2 | 8.0 Units on a scale | Standard Deviation 3 |
| Ibuprofen Sodium | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) | SPRID 0-6 | 24.3 Units on a scale | Standard Deviation 10.4 |
| Ibuprofen Sodium | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) | SPRID 0-3 | 12.6 Units on a scale | Standard Deviation 4.7 |
| Ibuprofen (Advil + Motrin IB) | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) | SPRID 0-8 | 31.7 Units on a scale | Standard Deviation 14.6 |
| Ibuprofen (Advil + Motrin IB) | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) | SPRID 0-3 | 11.8 Units on a scale | Standard Deviation 4.9 |
| Ibuprofen (Advil + Motrin IB) | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) | SPRID 0-6 | 25.0 Units on a scale | Standard Deviation 10.6 |
| Ibuprofen (Advil + Motrin IB) | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) | SPRID 0-2 | 7.0 Units on a scale | Standard Deviation 3.3 |
Comparison: SPRID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: <0.00195% CI: [5.6, 7.76]ANOVA
Comparison: SPRID 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: 0.00795% CI: [0.29, 1.84]ANOVA
Comparison: SPRID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: <0.00195% CI: [8.79, 12.08]ANOVA
Comparison: SPRID 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: 0.15295% CI: [-0.32, 2.05]ANOVA
Comparison: SPRID 0-6: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: <0.00195% CI: [16.23, 23.43]ANOVA
Comparison: SPRID 0-6: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: 0.6995% CI: [-3.12, 2.07]ANOVA
Comparison: SPRID 0-8 Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.p-value: 0.32395% CI: [-5.29, 1.75]ANOVA
Secondary
Time-weighted Sum of Pain Relief Rating (TOTPAR)
TOTPAR: time-weighted sum of PRR scores over 2, 3, 6 and 8 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2, 0 (worst) to 12 (best) for TOTPAR 0-3, 0 (worst) to 24 (best) for TOTPAR 0-6, 0 (worst) to 32 (best) for TOTPAR 0-8. PRR was evaluated at different time points during the study up to 8 hours, and immediately after taking rescue medication (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.
Time frame: 0-2, 0-3, 0-6, 0-8 hours
Population: ITT population included all randomized participants who received study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Time-weighted Sum of Pain Relief Rating (TOTPAR) | TOTPAR 0-6 | 4.2 Units on a scale | Standard Deviation 6.5 |
| Placebo | Time-weighted Sum of Pain Relief Rating (TOTPAR) | TOTPAR 0-2 | 1.3 Units on a scale | Standard Deviation 1.8 |
| Placebo | Time-weighted Sum of Pain Relief Rating (TOTPAR) | TOTPAR 0-8 | 5.2 Units on a scale | Standard Deviation 8.4 |
| Placebo | Time-weighted Sum of Pain Relief Rating (TOTPAR) | TOTPAR 0-3 | 2.0 Units on a scale | Standard Deviation 2.9 |
| Ibuprofen Sodium | Time-weighted Sum of Pain Relief Rating (TOTPAR) | TOTPAR 0-6 | 15.9 Units on a scale | Standard Deviation 6.1 |
| Ibuprofen Sodium | Time-weighted Sum of Pain Relief Rating (TOTPAR) | TOTPAR 0-3 | 8.1 Units on a scale | Standard Deviation 2.7 |
| Ibuprofen Sodium | Time-weighted Sum of Pain Relief Rating (TOTPAR) | TOTPAR 0-2 | 5.2 Units on a scale | Standard Deviation 1.7 |
| Ibuprofen Sodium | Time-weighted Sum of Pain Relief Rating (TOTPAR) | TOTPAR 0-8 | 19.5 Units on a scale | Standard Deviation 8.5 |
| Ibuprofen (Advil + Motrin IB) | Time-weighted Sum of Pain Relief Rating (TOTPAR) | TOTPAR 0-8 | 20.6 Units on a scale | Standard Deviation 8.5 |
| Ibuprofen (Advil + Motrin IB) | Time-weighted Sum of Pain Relief Rating (TOTPAR) | TOTPAR 0-2 | 4.6 Units on a scale | Standard Deviation 1.9 |
| Ibuprofen (Advil + Motrin IB) | Time-weighted Sum of Pain Relief Rating (TOTPAR) | TOTPAR 0-3 | 7.6 Units on a scale | Standard Deviation 2.8 |
| Ibuprofen (Advil + Motrin IB) | Time-weighted Sum of Pain Relief Rating (TOTPAR) | TOTPAR 0-6 | 16.1 Units on a scale | Standard Deviation 6.1 |
Comparison: TOTPAR 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [3.32, 4.59]ANOVA
Comparison: TOTPAR 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.00995% CI: [0.16, 1.07]ANOVA
Comparison: TOTPAR 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [5.18, 7.12]ANOVA
Comparison: TOTPAR 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.16695% CI: [-0.21, 1.2]ANOVA
Comparison: TOTPAR 0-6: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [9.54, 13.81]ANOVA
Comparison: TOTPAR 0-6: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.70395% CI: [-1.84, 1.24]ANOVA
Comparison: TOTPAR 0-8: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: <0.00195% CI: [11.36, 17.18]ANOVA
Comparison: TOTPAR 0-8: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.p-value: 0.30395% CI: [-3.2, 1]ANOVA