Ankle Injuries
Conditions
Keywords
topical ibuprofen, ankle sprain
Brief summary
This study is being conducted to evaluate the effects of IBU 5% Topical Gel versus topical placebo for the relief of pain associated with a first or second degree ankle sprain. Both twice daily and three times daily regimens will be evaluated.
Interventions
DRUGTopical IBU twice daily
Topical gel administered as 4 inch strip twice daily for 7 days, and as needed for an additional 3 days
Topical gel administered as a 4 inch strip twice daily for 7 days, and as needed for an additional 3 days
DRUGTopical IBU three times daily
Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days
Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* First or second degree ankle sprain within 48 hours of first dose of study medication * Medically cleared to participate
Exclusion criteria
* Similar injury of same joint within last 6 months * Requires bed rest, surgery, or over-the-counter or prescription analgesics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sum of Pain Intensity Difference (SPID) on Weight Bearing Over 3 Days (SPID WB0-3) | Over 3 Days (0-72 hours) | PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. Pain intensity difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 3 days (72 hours). Total score ranges from -360 (higher pain relief) to 432 (lower pain relief) for SPID WB0-3. SPID is a value of change from baseline and as pain score at base line is usually higher than that at post baseline, a negative value of SPID indicates higher pain relief from baseline. |
| Sum of Ankle Pain Intensity Difference on Weight Bearing Over 24 Hours After Dose 1 (SPID WB24) | 0 to 24 hours | PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -120 (higher pain relief) to 144 (lower pain relief) for SPID WB24. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while a positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sum of Pain Intensity Difference at Rest Over 24 Hours on Day 1 (SPID R24) | 0 to 24 hours | PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -240 (higher pain relief) to 96 (lower pain relief) for SPID at rest. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline. |
| Change From Baseline in Participant's Global Assessment of Ankle Injury at Day 3 and 10 | Baseline, Day 3, 10 | Participant's global assessments of ankle injury was measured using 5-point scale: 1= Very Good (No symptoms and no limitations of normal activities), 2= Good (Mild symptoms and no limitation of normal activities), 3= Fair (Moderate symptoms and limitations of some normal activities), 4= Poor (Severe symptoms and inability to carry out most normal activities), 5= Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). |
| Change From Baseline in Physician Global Assessment of Ankle Injury at Day 3 and 10 | Baseline, Day 3, 10 | The physician assessment of the severity of the ankle injury was based on the participant's individual signs and symptoms which included pain, swelling, tenderness and limitation of range of movement, and was measured using 6-point scale: 0= Normal (No signs or symptoms) , 1= Very mild (Very mild signs and symptoms), 2= Mild (Mild signs and symptoms), 3= Moderate (Moderate signs and symptoms), 4= Severe (Severe signs and symptoms), 5= Very severe (Very severe signs and symptoms). A higher score is indicative of lesser improvement. Change from baseline was calculated as baseline value minus post-treatment value. |
| Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Baseline, 1, 2, 3, 4, 5, 6, 12(Day1),24(Day2),30(Day2),36(Day2),48(Day3),50(Day3),54(Day3),60(Day3),72(Day4),78(Day4),84(Day4), 96(Day5),102(Day5), 108 (Day5), 120(Day6),126(Day6),132(Day6),144(Day7),150(Day7),156(Day7) hours post first dose on Day 1 | PI in ankle pain at rest and upon weight bearing was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. Pain score at baseline is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline. |
| Sum of Pain Intensity Difference at Rest and on Weight Bearing Over 6 Hours on Day 1 and Over 2 Hours on Day 3 | Over 6 hours on Day 1, over 2 hours on Day 3 | PI at rest and on weight bearing was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID 0-6 was calculated as the time-weighted sum of PID scores over 6 hours on Day 1, with a total score ranges from -30 (higher pain relief) to 36 (lower pain relief). SPID 0-12 was calculated as the time weighted sum of PID scores over 2 hours on Day 3, with a total score ranges from -10 (higher pain relief) to 12 (lower pain relief). SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline. |
| Sum of Pain Intensity Difference Scores at Rest Over 3 Days | Over 3 Days (0-72 hours) | PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 3 days (72 hours). Total score ranges from -360 (higher pain relief) to 432 (lower pain relief). SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline. |
| Sum of Pain Intensity Difference Scores at Rest and on Weight Bearing Over 7 Days | Over 7 days (0-168 hours) | PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 7 days (168 hours). Total score ranges from -840 (higher pain relief) to 1008 (lower pain relief). SPID is a value of change from baseline. Pain score at baseline is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline. |
| Change From Baseline in Participant Assessment of Normal Function and Activity at Day 3 and 10 | Baseline, Day 3, 10 | Participant assessment of normal function was measured using a 5-point scale: 1= Normal walking/activity and no pain; 2= Normal walking/activity with pain; 3= Mildly restricted walking due to pain and can't resume normal activities; 4= Moderately restricted walking due to pain and can't resume normal activities; 5= Severely restricted walking due to pain and can't resume normal activities. The normal functioning and activity scores for each question range from 1 to 5, with higher scores indicating worsening of normal activity. |
| Participant's Global Assessment of Medication at End of Study | Day 10 | Participants Global Assessment of Medication was used to rate the medication as a pain reliever. The responses of participants were recorded using 5-point scale: 1= Very Poor, 2= Poor, 3= Fair, 4= Good, 5= Very Good. The global assessment of medication scores for each question range from 0 to 5, giving a possible score range of 0 - 5, with higher scores indicating medication as a better pain reliever. |
| Time to First Perceptible Relief and Meaningful Relief | 0 to 3 hours on Day 1 | Participants evaluated time to first perceptible relief by stopping a stopwatch labelled 'first perceptible relief' at moment participant first began to experience any relief, exact question asked was: Stop stopwatch when you first begin to feel any pain-relieving effect whatsoever of product; that is, when you first feel a little relief. First perceptible relief was considered confirmed by meaningful relief if participant achieved both first perceptible and meaningful relief by either pressing second stopwatch or by indicating that his/her first perceptible relief was also meaningful. For time to meaningful relief, exact question asked was: Stop this stopwatch when you have meaningful relief; that is, when relief from pain is meaningful to you. Stopwatches were active up to 3 hours after dosing or until stopped by participant, or rescue medication was administered. |
| Time to Rescue Medication After Initial Dose, and After Each Subsequent Dose | Post-Dose on Day 1 up to Day 10 | Participants used only acetaminophen at a dose of 500 milligram (mg) every 6 hours product as needed (PRN) as rescue medication during the course of the study. Participants who used acetaminophen were to record its use, and date and time of administration in the participant diary. Time to rescue medication after initial dose, after each subsequent dose, provided that in each dose interval at least 25% of the participants take rescue medication was analyzed using the proportional hazard model with site, treatment group, and baseline categorical ankle pain terms in the model. |
| Number of Doses of Rescue Medication Used During the First 7 Days of Dosing | Baseline up to Day 7 | Participants received only acetaminophen 500 mg every 6 hours PRN as rescue medication during the course of the study. |
| Percentage of Participants Taking Rescue Medication | Post first dose Day 1 up to Day 10 | Participants used only acetaminophen at a dose of 500 mg every 6 hours PRN as analgesia or rescue therapy during the course of the study. Participants who used acetaminophen were to record its use, and date and time of administration in the participant diary. |
Countries
United States
Participant flow
Recruitment details
Study was conducted in United States from 08 November 2013 to 19 February 2015.
Pre-assignment details
Out of the 348 screened participants, 304 were randomized and received treatment.
Participants by arm
| Arm | Count |
|---|---|
| Ibuprofen Twice Daily Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen. | 67 |
| Ibuprofen Thrice Daily Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen. | 85 |
| Placebo Combined Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days. | 152 |
| Total | 304 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 2 |
| Overall Study | Medication Error | 0 | 1 | 0 |
| Overall Study | Other | 0 | 1 | 3 |
| Overall Study | Protocol Violation | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 3 | 1 |
Baseline characteristics
| Characteristic | Ibuprofen Thrice Daily | Ibuprofen Twice Daily | Total | Placebo Combined |
|---|---|---|---|---|
| Age, Continuous | 35.2 years STANDARD_DEVIATION 14.72 | 31.7 years STANDARD_DEVIATION 15.2 | 33.3 years STANDARD_DEVIATION 14.43 | 33.0 years STANDARD_DEVIATION 13.9 |
| Baseline Ankle Pain at Rest | 6.5 Units on a scale STANDARD_DEVIATION 1.48 | 6.2 Units on a scale STANDARD_DEVIATION 1.77 | 6.4 Units on a scale STANDARD_DEVIATION 1.65 | 6.5 Units on a scale STANDARD_DEVIATION 1.7 |
| Baseline Ankle Pain upon Weight Bearing | 8.1 Units on a scale STANDARD_DEVIATION 1.13 | 8.3 Units on a scale STANDARD_DEVIATION 1.25 | 8.3 Units on a scale STANDARD_DEVIATION 1.18 | 8.4 Units on a scale STANDARD_DEVIATION 1.17 |
| Baseline Participant Assessment of Normal Function/Activity Mild restrict walking(3) | 26 participants | 16 participants | 68 participants | 26 participants |
| Baseline Participant Assessment of Normal Function/Activity Moderate restrict walking(4) | 45 participants | 43 participants | 179 participants | 91 participants |
| Baseline Participant Assessment of Normal Function/Activity Normal walking/activity and no pain(1) | 0 participants | 0 participants | 0 participants | 0 participants |
| Baseline Participant Assessment of Normal Function/Activity Normal walking/activity with pain(2) | 4 participants | 1 participants | 14 participants | 9 participants |
| Baseline Participant Assessment of Normal Function/Activity Severe restrict walking(5) | 10 participants | 7 participants | 43 participants | 26 participants |
| Baseline Participant's Global Assessment of Ankle Injury Fair(3) | 56 participants | 34 participants | 167 participants | 77 participants |
| Baseline Participant's Global Assessment of Ankle Injury Good(2) | 0 participants | 0 participants | 7 participants | 7 participants |
| Baseline Participant's Global Assessment of Ankle Injury Poor(4) | 25 participants | 30 participants | 110 participants | 55 participants |
| Baseline Participant's Global Assessment of Ankle Injury Very Good(1) | 0 participants | 0 participants | 0 participants | 0 participants |
| Baseline Participant's Global Assessment of Ankle Injury Very Poor(5) | 4 participants | 3 participants | 20 participants | 13 participants |
| Baseline Physician Global Assessment of Ankle Injury Mild(2) | 28 participants | 9 participants | 67 participants | 30 participants |
| Baseline Physician Global Assessment of Ankle Injury Moderate(3) | 54 participants | 50 participants | 205 participants | 101 participants |
| Baseline Physician Global Assessment of Ankle Injury Normal(0) | 0 participants | 0 participants | 0 participants | 0 participants |
| Baseline Physician Global Assessment of Ankle Injury Severe(4) | 3 participants | 8 participants | 31 participants | 20 participants |
| Baseline Physician Global Assessment of Ankle Injury Very mild(1) | 0 participants | 0 participants | 1 participants | 1 participants |
| Baseline Physician Global Assessment of Ankle Injury Very severe(5) | 0 participants | 0 participants | 0 participants | 0 participants |
| Categorical Pain Severity Rating (PSR) Moderate | 63 participants 1.13 | 43 participants 1.25 | 208 participants | 102 participants 1.17 |
| Categorical Pain Severity Rating (PSR) Severe | 22 participants | 24 participants | 96 participants | 50 participants |
| Sex: Female, Male Female | 39 Participants | 34 Participants | 134 Participants | 61 Participants |
| Sex: Female, Male Male | 46 Participants | 33 Participants | 170 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 67 | 5 / 85 | 13 / 152 |
| serious Total, serious adverse events | 1 / 67 | 0 / 85 | 0 / 152 |
Outcome results
Primary
Sum of Ankle Pain Intensity Difference on Weight Bearing Over 24 Hours After Dose 1 (SPID WB24)
PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -120 (higher pain relief) to 144 (lower pain relief) for SPID WB24. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while a positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.
Time frame: 0 to 24 hours
Population: The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ibuprofen Twice Daily | Sum of Ankle Pain Intensity Difference on Weight Bearing Over 24 Hours After Dose 1 (SPID WB24) | 46.9 units on a scale | Standard Error 5.03 |
| Ibuprofen Thrice Daily | Sum of Ankle Pain Intensity Difference on Weight Bearing Over 24 Hours After Dose 1 (SPID WB24) | 41.1 units on a scale | Standard Error 4.62 |
| Placebo Combined | Sum of Ankle Pain Intensity Difference on Weight Bearing Over 24 Hours After Dose 1 (SPID WB24) | 42.1 units on a scale | Standard Error 3.51 |
Comparison: The ANOVA model was used which contains treatment, baseline categorical pain severity rating (BLPSR), pooled site blocks, and baseline pain intensity on weight bearing (BLPIWB) terms. 95% CI not includes 0 for treatment effect. Upper limit of 95% CI\< 0 for Ibuprofen treatment significantly better than combined Placebo. Comparison: tested at the 0.05 level of significance (2-sided). A comparison was eligible for being declared significant only if preceding comparison was significant.p-value: 0.42695% CI: [-6.98, 16.49]ANOVA
Comparison: The ANOVA model was used which contains treatment, BLPSR, pooled site blocks, and BLPIWB terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo. Comparison: tested at the 0.05 level of significance (2-sided). A comparison was eligible for being declared significant only if preceding comparison was significant.p-value: 0.8595% CI: [-11.9, 9.82]ANOVA
Comparison: The ANOVA model was used which contains treatment, BLPSR, pooled site blocks, and BLPIWB terms. A comparison was eligible for being declared significant only if preceding comparison was significant.p-value: 0.38595% CI: [-18.91, 7.32]ANOVA
Primary
Sum of Pain Intensity Difference (SPID) on Weight Bearing Over 3 Days (SPID WB0-3)
PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. Pain intensity difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 3 days (72 hours). Total score ranges from -360 (higher pain relief) to 432 (lower pain relief) for SPID WB0-3. SPID is a value of change from baseline and as pain score at base line is usually higher than that at post baseline, a negative value of SPID indicates higher pain relief from baseline.
Time frame: Over 3 Days (0-72 hours)
Population: The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ibuprofen Twice Daily | Sum of Pain Intensity Difference (SPID) on Weight Bearing Over 3 Days (SPID WB0-3) | 188.9 units on a scale | Standard Error 14.81 |
| Ibuprofen Thrice Daily | Sum of Pain Intensity Difference (SPID) on Weight Bearing Over 3 Days (SPID WB0-3) | 173.6 units on a scale | Standard Error 13.6 |
| Placebo Combined | Sum of Pain Intensity Difference (SPID) on Weight Bearing Over 3 Days (SPID WB0-3) | 165.9 units on a scale | Standard Error 10.34 |
Comparison: The analysis of variance (ANOVA) model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.1995% CI: [-11.49, 57.56]ANOVA
Comparison: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.63395% CI: [-24.2, 39.7]ANOVA
Comparison: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms.p-value: 0.43695% CI: [-53.87, 23.3]ANOVA
Secondary
Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points
PI in ankle pain at rest and upon weight bearing was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. Pain score at baseline is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline.
Time frame: Baseline, 1, 2, 3, 4, 5, 6, 12(Day1),24(Day2),30(Day2),36(Day2),48(Day3),50(Day3),54(Day3),60(Day3),72(Day4),78(Day4),84(Day4), 96(Day5),102(Day5), 108 (Day5), 120(Day6),126(Day6),132(Day6),144(Day7),150(Day7),156(Day7) hours post first dose on Day 1
Population: The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 5 Mid-day | 3.7 units on a scale | Standard Error 0.27 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 2(AM) | 2.0 units on a scale | Standard Error 0.22 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest 2 hour Day 1 | 1.7 units on a scale | Standard Error 0.22 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 5(PM) | 3.4 units on a scale | Standard Error 0.25 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 3(PM) | 3.0 units on a scale | Standard Error 0.23 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing 1 hour Day 1 | 1.5 units on a scale | Standard Error 0.2 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 5(PM) | 3.8 units on a scale | Standard Error 0.28 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 3(AM + 2 hours) | 2.8 units on a scale | Standard Error 0.24 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 1(PM) | 2.0 units on a scale | Standard Error 0.24 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest 1 hour Day 1 | 1.3 units on a scale | Standard Error 0.19 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 6(AM) | 3.9 units on a scale | Standard Error 0.28 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 3(PM) | 3.1 units on a scale | Standard Error 0.25 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 7(PM) | 3.9 units on a scale | Standard Error 0.25 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 6 Mid-day | 3.5 units on a scale | Standard Error 0.25 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 2(PM) | 2.4 units on a scale | Standard Error 0.24 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 6(AM) | 3.5 units on a scale | Standard Error 0.25 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 6 Mid-day | 3.8 units on a scale | Standard Error 0.28 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 1(PM) | 1.8 units on a scale | Standard Error 0.22 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 7(PM) | 4.5 units on a scale | Standard Error 0.29 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 6(PM) | 3.6 units on a scale | Standard Error 0.26 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 4(AM) | 3.2 units on a scale | Standard Error 0.23 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 7 Mid-day | 4.6 units on a scale | Standard Error 0.29 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 6(PM) | 3.9 units on a scale | Standard Error 0.29 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 2 Mid-day | 2.5 units on a scale | Standard Error 0.24 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 7 Mid-day | 4.0 units on a scale | Standard Error 0.25 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 7(AM) | 3.6 units on a scale | Standard Error 0.25 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing 6 hour Day 1 | 2.1 units on a scale | Standard Error 0.25 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 7(AM) | 4.2 units on a scale | Standard Error 0.29 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 4(AM) | 3.4 units on a scale | Standard Error 0.25 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 3(AM + 2 hours) | 2.9 units on a scale | Standard Error 0.26 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest 6 hour Day 1 | 1.9 units on a scale | Standard Error 0.24 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 4 Mid-day | 3.2 units on a scale | Standard Error 0.25 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 2(PM) | 2.2 units on a scale | Standard Error 0.23 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Upon Weight Bearing: 5 hour Day 1 | 2.2 units on a scale | Standard Error 0.26 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 4 Mid-day | 3.5 units on a scale | Standard Error 0.27 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 2 Mid-day | 2.3 units on a scale | Standard Error 0.23 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest 5 hour Day 1 | 1.9 units on a scale | Standard Error 0.24 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 4(PM) | 3.2 units on a scale | Standard Error 0.24 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 3 Mid-day | 3.0 units on a scale | Standard Error 0.23 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing 4 hour Day 1 | 1.9 units on a scale | Standard Error 0.25 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 4(PM) | 3.4 units on a scale | Standard Error 0.27 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 3(AM) | 2.8 units on a scale | Standard Error 0.25 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest 4 hour Day 1 | 1.8 units on a scale | Standard Error 0.24 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 5(AM) | 3.3 units on a scale | Standard Error 0.24 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 2(AM) | 2.0 units on a scale | Standard Error 0.24 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing 3 hour Day 1 | 2.2 units on a scale | Standard Error 0.25 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 5(AM) | 3.7 units on a scale | Standard Error 0.27 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 3 Mid-day | 3.2 units on a scale | Standard Error 0.26 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest 3 hour Day 1 | 1.9 units on a scale | Standard Error 0.23 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 5 Mid-day | 3.4 units on a scale | Standard Error 0.25 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 3(AM) | 2.7 units on a scale | Standard Error 0.22 |
| Ibuprofen Twice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing 2 hour Day 1 | 1.8 units on a scale | Standard Error 0.23 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest 4 hour Day 1 | 1.2 units on a scale | Standard Error 0.22 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 3(AM) | 2.0 units on a scale | Standard Error 0.21 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 3(AM) | 2.7 units on a scale | Standard Error 0.23 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 3(AM + 2 hours) | 2.2 units on a scale | Standard Error 0.22 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 3(AM + 2 hours) | 2.9 units on a scale | Standard Error 0.24 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 3 Mid-day | 2.2 units on a scale | Standard Error 0.22 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 3 Mid-day | 2.9 units on a scale | Standard Error 0.24 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 3(PM) | 2.1 units on a scale | Standard Error 0.22 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 3(PM) | 2.8 units on a scale | Standard Error 0.23 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 4(AM) | 2.5 units on a scale | Standard Error 0.21 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 4(AM) | 3.2 units on a scale | Standard Error 0.23 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 4 Mid-day | 2.5 units on a scale | Standard Error 0.23 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 4 Mid-day | 3.3 units on a scale | Standard Error 0.25 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 4(PM) | 2.7 units on a scale | Standard Error 0.22 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 4(PM) | 3.4 units on a scale | Standard Error 0.25 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 5(AM) | 2.8 units on a scale | Standard Error 0.22 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 5(AM) | 3.5 units on a scale | Standard Error 0.24 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 5 Mid-day | 2.9 units on a scale | Standard Error 0.23 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 5 Mid-day | 3.7 units on a scale | Standard Error 0.25 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 5(PM) | 3.0 units on a scale | Standard Error 0.23 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 5(PM) | 3.7 units on a scale | Standard Error 0.26 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 6(AM) | 3.2 units on a scale | Standard Error 0.23 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 6(AM) | 4.0 units on a scale | Standard Error 0.26 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 6 Mid-day | 3.3 units on a scale | Standard Error 0.23 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 6 Mid-day | 4.1 units on a scale | Standard Error 0.26 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 6(PM) | 3.3 units on a scale | Standard Error 0.24 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 6(PM) | 4.2 units on a scale | Standard Error 0.27 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 7(AM) | 3.5 units on a scale | Standard Error 0.23 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 7(AM) | 4.5 units on a scale | Standard Error 0.27 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 7 Mid-day | 3.6 units on a scale | Standard Error 0.23 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 7 Mid-day | 4.5 units on a scale | Standard Error 0.27 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 7(PM) | 3.7 units on a scale | Standard Error 0.23 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 7(PM) | 4.7 units on a scale | Standard Error 0.27 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest 1 hour Day 1 | 0.7 units on a scale | Standard Error 0.17 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing 1 hour Day 1 | 1.1 units on a scale | Standard Error 0.18 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest 2 hour Day 1 | 1.2 units on a scale | Standard Error 0.2 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing 2 hour Day 1 | 1.5 units on a scale | Standard Error 0.21 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest 3 hour Day 1 | 1.2 units on a scale | Standard Error 0.22 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing 3 hour Day 1 | 1.7 units on a scale | Standard Error 0.23 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 2(PM) | 2.4 units on a scale | Standard Error 0.22 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing 4 hour Day 1 | 1.8 units on a scale | Standard Error 0.23 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest 5 hour Day 1 | 1.1 units on a scale | Standard Error 0.22 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Upon Weight Bearing: 5 hour Day 1 | 1.6 units on a scale | Standard Error 0.24 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest 6 hour Day 1 | 1.1 units on a scale | Standard Error 0.22 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing 6 hour Day 1 | 1.6 units on a scale | Standard Error 0.23 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 1(PM) | 1.1 units on a scale | Standard Error 0.2 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 1(PM) | 1.6 units on a scale | Standard Error 0.22 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 2(AM) | 1.3 units on a scale | Standard Error 0.2 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 2(AM) | 1.8 units on a scale | Standard Error 0.22 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 2 Mid-day | 1.7 units on a scale | Standard Error 0.21 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 2 Mid-day | 2.1 units on a scale | Standard Error 0.22 |
| Ibuprofen Thrice Daily | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 2(PM) | 1.9 units on a scale | Standard Error 0.21 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 5 Mid-day | 3.3 units on a scale | Standard Error 0.19 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 1(PM) | 1.6 units on a scale | Standard Error 0.17 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest 2 hour Day 1 | 1.5 units on a scale | Standard Error 0.15 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 5 Mid-day | 2.7 units on a scale | Standard Error 0.17 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 3 Mid-day | 2.7 units on a scale | Standard Error 0.18 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing 2 hour Day 1 | 1.8 units on a scale | Standard Error 0.16 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 5(AM) | 3.3 units on a scale | Standard Error 0.19 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 2 Mid-day | 2.1 units on a scale | Standard Error 0.17 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest 3 hour Day 1 | 1.6 units on a scale | Standard Error 0.16 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 5(AM) | 2.7 units on a scale | Standard Error 0.17 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 2(AM) | 1.6 units on a scale | Standard Error 0.15 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing 3 hour Day 1 | 1.9 units on a scale | Standard Error 0.17 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 4(PM) | 3.1 units on a scale | Standard Error 0.19 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 3 Mid-day | 2.3 units on a scale | Standard Error 0.16 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest 4 hour Day 1 | 1.5 units on a scale | Standard Error 0.16 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 4(PM) | 2.5 units on a scale | Standard Error 0.17 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 3(AM) | 2.1 units on a scale | Standard Error 0.16 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing 4 hour Day 1 | 1.7 units on a scale | Standard Error 0.18 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 4 Mid-day | 3.2 units on a scale | Standard Error 0.19 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 2(AM) | 1.9 units on a scale | Standard Error 0.17 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest 5 hour Day 1 | 1.4 units on a scale | Standard Error 0.16 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 4 Mid-day | 2.5 units on a scale | Standard Error 0.17 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 3(AM + 2 hours) | 2.6 units on a scale | Standard Error 0.18 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Upon Weight Bearing: 5 hour Day 1 | 1.7 units on a scale | Standard Error 0.18 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 4(AM) | 3.0 units on a scale | Standard Error 0.18 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 2(PM) | 2.1 units on a scale | Standard Error 0.17 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest 6 hour Day 1 | 1.2 units on a scale | Standard Error 0.16 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 4(AM) | 2.6 units on a scale | Standard Error 0.16 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 7(AM) | 3.1 units on a scale | Standard Error 0.17 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 2 Mid-day | 1.8 units on a scale | Standard Error 0.16 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 7(AM) | 3.9 units on a scale | Standard Error 0.2 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 6(PM) | 3.7 units on a scale | Standard Error 0.2 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing 6 hour Day 1 | 1.5 units on a scale | Standard Error 0.17 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 7 Mid-day | 3.2 units on a scale | Standard Error 0.18 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 6(PM) | 2.9 units on a scale | Standard Error 0.18 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 3(PM) | 2.7 units on a scale | Standard Error 0.18 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 3(AM + 2 hours) | 2.2 units on a scale | Standard Error 0.16 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 7(PM) | 3.4 units on a scale | Standard Error 0.17 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 6 Mid-day | 3.7 units on a scale | Standard Error 0.2 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 1(PM) | 1.2 units on a scale | Standard Error 0.15 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 7(PM) | 4.2 units on a scale | Standard Error 0.2 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 3(AM) | 2.5 units on a scale | Standard Error 0.17 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 5(PM) | 3.5 units on a scale | Standard Error 0.19 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 6 Mid-day | 3.1 units on a scale | Standard Error 0.17 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 7 Mid-day | 4.1 units on a scale | Standard Error 0.2 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing Day 6(AM) | 3.8 units on a scale | Standard Error 0.2 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 6(AM) | 3.1 units on a scale | Standard Error 0.17 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 3(PM) | 2.3 units on a scale | Standard Error 0.16 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest 1 hour Day 1 | 1.2 units on a scale | Standard Error 0.13 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 5(PM) | 2.8 units on a scale | Standard Error 0.17 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: At Rest Day 2(PM) | 1.8 units on a scale | Standard Error 0.16 |
| Placebo Combined | Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points | Change at: Upon Weight Bearing 1 hour Day 1 | 1.4 units on a scale | Standard Error 0.14 |
Comparison: At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.77195% CI: [-0.38, 0.51]ANOVA
Comparison: At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.02295% CI: [-0.88, -0.07]ANOVA
Comparison: At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.03295% CI: [-1.03, -0.05]ANOVA
Comparison: Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.7295% CI: [-0.38, 0.55]ANOVA
Comparison: Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.19495% CI: [-0.71, 0.15]ANOVA
Comparison: Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.16395% CI: [-0.89, 0.15]ANOVA
Comparison: At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.64495% CI: [-0.4, 0.64]ANOVA
Comparison: At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.12995% CI: [-0.85, 0.11]ANOVA
Comparison: At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.09695% CI: [-1.07, 0.09]ANOVA
Comparison: Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.90595% CI: [-0.5, 0.57]ANOVA
Comparison: Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.27995% CI: [-0.77, 0.22]ANOVA
Comparison: Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.31595% CI: [-0.9, 0.29]ANOVA
Comparison: At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.20395% CI: [-0.19, 0.91]ANOVA
Comparison: At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.20795% CI: [-0.83, 0.18]ANOVA
Comparison: At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.0395% CI: [-1.3, -0.07]ANOVA
Comparison: Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.37295% CI: [-0.32, 0.84]ANOVA
Comparison: Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.53295% CI: [-0.7, 0.36]ANOVA
Comparison: Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.18995% CI: [-1.08, 0.21]ANOVA
Comparison: At Rest 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.26495% CI: [-0.24, 0.87]ANOVA
Comparison: At Rest 4 hour Day 1:The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.2695% CI: [-0.81, 0.22]ANOVA
Comparison: At Rest 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.05495% CI: [-1.23, 0.01]ANOVA
Comparison: Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.45695% CI: [-0.37, 0.81]ANOVA
Comparison: Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.63995% CI: [-0.42, 0.68]ANOVA
Comparison: Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.7895% CI: [-0.75, 0.57]ANOVA
Comparison: At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.07195% CI: [-0.04, 1.07]ANOVA
Comparison: At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.46895% CI: [-0.7, 0.32]ANOVA
Comparison: At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.02795% CI: [-1.33, -0.08]ANOVA
Comparison: Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.10795% CI: [-0.11, 1.09]ANOVA
Comparison: Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.94795% CI: [-0.57, 0.53]ANOVA
Comparison: Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.13495% CI: [-1.18, 0.16]ANOVA
Comparison: At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.01795% CI: [0.12, 1.23]ANOVA
Comparison: At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.71595% CI: [-0.6, 0.41]ANOVA
Comparison: At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.01595% CI: [-1.39, -0.15]ANOVA
Comparison: Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.02795% CI: [0.07, 1.23]ANOVA
Comparison: Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.6695% CI: [-0.42, 0.65]ANOVA
Comparison: Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.10795% CI: [-1.18, 0.11]ANOVA
Comparison: At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.0295% CI: [0.1, 1.13]ANOVA
Comparison: At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.74995% CI: [-0.55, 0.4]ANOVA
Comparison: At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.01995% CI: [-1.27, -0.12]ANOVA
Comparison: Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.16395% CI: [-0.16, 0.96]ANOVA
Comparison: Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.72795% CI: [-0.43, 0.61]ANOVA
Comparison: Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.33695% CI: [-0.94, 0.32]ANOVA
Comparison: At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.17495% CI: [-0.16, 0.87]ANOVA
Comparison: At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.27795% CI: [-0.73, 0.21]ANOVA
Comparison: At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.03595% CI: [-1.19, -0.04]ANOVA
Comparison: Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.85895% CI: [-0.5, 0.6]ANOVA
Comparison: Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.72495% CI: [-0.6, 0.42]ANOVA
Comparison: Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.65195% CI: [-0.76, 0.48]ANOVA
Comparison: At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.05995% CI: [-0.02, 1.05]ANOVA
Comparison: At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.76695% CI: [-0.57, 0.42]ANOVA
Comparison: At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.05395% CI: [-1.19, 0.01]ANOVA
Comparison: Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.21295% CI: [-0.21, 0.92]ANOVA
Comparison: Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.91195% CI: [-0.49, 0.55]ANOVA
Comparison: Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.30595% CI: [-0.96, 0.3]ANOVA
Comparison: At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.07595% CI: [-0.05, 1.02]ANOVA
Comparison: At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.68495% CI: [-0.39, 0.6]ANOVA
Comparison: At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.20895% CI: [-0.98, 0.21]ANOVA
Comparison: Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.30495% CI: [-0.27, 0.85]ANOVA
Comparison: Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.35695% CI: [-0.27, 0.76]ANOVA
Comparison: Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.87695% CI: [-0.67, 0.58]ANOVA
Comparison: At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.0295% CI: [0.1, 1.15]ANOVA
Comparison: At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.9495% CI: [-0.5, 0.47]ANOVA
Comparison: At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.03295% CI: [-1.23, -0.06]ANOVA
Comparison: Upon Weight Bearing Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.20695% CI: [-0.21, 0.95]ANOVA
Comparison: Upon Weight Bearing Day 3(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.3195% CI: [-0.26, 0.81]ANOVA
Comparison: Upon Weight Bearing Day 3(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.77195% CI: [-0.74, 0.55]ANOVA
Comparison: At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.01695% CI: [0.13, 1.24]ANOVA
Comparison: At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.90595% CI: [-0.48, 0.54]ANOVA
Comparison: At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.03995% CI: [-1.28, -0.03]ANOVA
Comparison: Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.27695% CI: [-0.27, 0.93]ANOVA
Comparison: Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.34395% CI: [-0.29, 0.82]ANOVA
Comparison: Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.84995% CI: [-0.73, 0.6]ANOVA
Comparison: At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.00995% CI: [0.19, 1.29]ANOVA
Comparison: At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.76395% CI: [-0.58, 0.43]ANOVA
Comparison: At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.0195% CI: [-1.43, -0.2]ANOVA
Comparison: Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.10595% CI: [-0.1, 1.09]ANOVA
Comparison: Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.53395% CI: [-0.38, 0.73]ANOVA
Comparison: Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.34895% CI: [-0.99, 0.35]ANOVA
Comparison: At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.01695% CI: [0.13, 1.23]ANOVA
Comparison: At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.48395% CI: [-0.69, 0.33]ANOVA
Comparison: At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.00695% CI: [-1.47, -0.25]ANOVA
Comparison: Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.17795% CI: [-0.19, 1]ANOVA
Comparison: Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.58695% CI: [-0.4, 0.7]ANOVA
Comparison: Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.44895% CI: [-0.92, 0.41]ANOVA
Comparison: At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.04395% CI: [0.02, 1.09]ANOVA
Comparison: At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.68895% CI: [-0.59, 0.39]ANOVA
Comparison: At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.03295% CI: [-1.25, -0.06]ANOVA
Comparison: Upon Weight Bearing Day 4(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.17995% CI: [-0.19, 0.99]ANOVA
Comparison: Upon Weight Bearing Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.60995% CI: [-0.4, 0.69]ANOVA
Comparison: Upon Weight Bearing Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.43595% CI: [-0.92, 0.4]ANOVA
Comparison: At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.02395% CI: [0.1, 1.26]ANOVA
Comparison: At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.98795% CI: [-0.54, 0.53]ANOVA
Comparison: At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.0495% CI: [-1.33, -0.03]ANOVA
Comparison: Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.31995% CI: [-0.31, 0.94]ANOVA
Comparison: Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.71295% CI: [-0.47, 0.69]ANOVA
Comparison: Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.55795% CI: [-0.91, 0.49]ANOVA
Comparison: At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.01595% CI: [0.14, 1.28]ANOVA
Comparison: At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.32695% CI: [-0.26, 0.79]ANOVA
Comparison: At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.16795% CI: [-1.08, 0.19]ANOVA
Comparison: Upon Weight Bearing Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.3595% CI: [-0.33, 0.93]ANOVA
Comparison: Upon Weight Bearing Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.23595% CI: [-0.23, 0.93]ANOVA
Comparison: Upon Weight Bearing Day 4(PM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.88195% CI: [-0.65, 0.76]ANOVA
Comparison: At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.03695% CI: [0.04, 1.16]ANOVA
Comparison: At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.65695% CI: [-0.4, 0.63]ANOVA
Comparison: At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.1395% CI: [-1.11, 0.14]ANOVA
Comparison: Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.30495% CI: [-0.3, 0.95]ANOVA
Comparison: Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.49195% CI: [-0.37, 0.78]ANOVA
Comparison: Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.72695% CI: [-0.82, 0.57]ANOVA
Comparison: At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.02995% CI: [0.07, 1.23]ANOVA
Comparison: At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.58595% CI: [-0.39, 0.68]ANOVA
Comparison: At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.13195% CI: [-1.15, 0.15]ANOVA
Comparison: Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.21595% CI: [-0.24, 1.04]ANOVA
Comparison: Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.24495% CI: [-0.24, 0.94]ANOVA
Comparison: Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.88595% CI: [-0.76, 0.66]ANOVA
Comparison: At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.06795% CI: [-0.04, 1.13]ANOVA
Comparison: At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.595% CI: [-0.35, 0.73]ANOVA
Comparison: At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.27695% CI: [-1.02, 0.29]ANOVA
Comparison: Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.41395% CI: [-0.38, 0.92]ANOVA
Comparison: Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.44895% CI: [-0.37, 0.83]ANOVA
Comparison: Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.91795% CI: [-0.76, 0.69]ANOVA
Comparison: At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.13295% CI: [-0.13, 1.03]ANOVA
Comparison: At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.50595% CI: [-0.35, 0.72]ANOVA
Comparison: At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.42295% CI: [-0.92, 0.38]ANOVA
Comparison: Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.74795% CI: [-0.54, 0.76]ANOVA
Comparison: Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.38695% CI: [-0.34, 0.87]ANOVA
Comparison: Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.66895% CI: [-0.57, 0.89]ANOVA
Comparison: At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.09995% CI: [-0.09, 1.08]ANOVA
Comparison: At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.36595% CI: [-0.29, 0.79]ANOVA
Comparison: At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.46395% CI: [-0.9, 0.41]ANOVA
Comparison: Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.84595% CI: [-0.6, 0.73]ANOVA
Comparison: Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.19995% CI: [-0.21, 1.02]ANOVA
Comparison: Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.37595% CI: [-0.41, 1.08]ANOVA
Comparison: At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.02895% CI: [0.07, 1.27]ANOVA
Comparison: At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.18895% CI: [-0.18, 0.92]ANOVA
Comparison: At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.37595% CI: [-0.97, 0.37]ANOVA
Comparison: Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.55295% CI: [-0.47, 0.89]ANOVA
Comparison: Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.12695% CI: [-0.14, 1.12]ANOVA
Comparison: Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.4695% CI: [-0.47, 1.05]ANOVA
Comparison: At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.09595% CI: [-0.09, 1.09]ANOVA
Comparison: At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.14695% CI: [-0.14, 0.94]ANOVA
Comparison: At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.76995% CI: [-0.75, 0.56]ANOVA
Comparison: Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.40595% CI: [-0.39, 0.96]ANOVA
Comparison: Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.07395% CI: [-0.05, 1.2]ANOVA
Comparison: Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.45895% CI: [-0.47, 1.04]ANOVA
Comparison: At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.00995% CI: [0.2, 1.39]ANOVA
Comparison: At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.20995% CI: [-0.2, 0.9]ANOVA
Comparison: At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.19395% CI: [-1.11, 0.22]ANOVA
Comparison: Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.14995% CI: [-0.18, 1.18]ANOVA
Comparison: Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.18695% CI: [-0.21, 1.06]ANOVA
Comparison: Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.84595% CI: [-0.84, 0.69]ANOVA
Comparison: At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.06795% CI: [-0.04, 1.14]ANOVA
Comparison: At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.24295% CI: [-0.22, 0.87]ANOVA
Comparison: At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.49895% CI: [-0.88, 0.43]ANOVA
Comparison: Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.3395% CI: [-0.34, 1.02]ANOVA
Comparison: Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.12495% CI: [-0.14, 1.13]ANOVA
Comparison: Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.68795% CI: [-0.61, 0.92]ANOVA
Secondary
Change From Baseline in Participant Assessment of Normal Function and Activity at Day 3 and 10
Participant assessment of normal function was measured using a 5-point scale: 1= Normal walking/activity and no pain; 2= Normal walking/activity with pain; 3= Mildly restricted walking due to pain and can't resume normal activities; 4= Moderately restricted walking due to pain and can't resume normal activities; 5= Severely restricted walking due to pain and can't resume normal activities. The normal functioning and activity scores for each question range from 1 to 5, with higher scores indicating worsening of normal activity.
Time frame: Baseline, Day 3, 10
Population: The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Ibuprofen Twice Daily | Change From Baseline in Participant Assessment of Normal Function and Activity at Day 3 and 10 | Change at: Day 3 | 1.0 Units on a scale | Standard Error 0.1 |
| Ibuprofen Twice Daily | Change From Baseline in Participant Assessment of Normal Function and Activity at Day 3 and 10 | Change at: Day 10 | 2.1 Units on a scale | Standard Error 0.07 |
| Ibuprofen Thrice Daily | Change From Baseline in Participant Assessment of Normal Function and Activity at Day 3 and 10 | Change at: Day 3 | 0.9 Units on a scale | Standard Error 0.09 |
| Ibuprofen Thrice Daily | Change From Baseline in Participant Assessment of Normal Function and Activity at Day 3 and 10 | Change at: Day 10 | 2.1 Units on a scale | Standard Error 0.09 |
| Placebo Combined | Change From Baseline in Participant Assessment of Normal Function and Activity at Day 3 and 10 | Change at: Day 3 | 0.7 Units on a scale | Standard Error 0.07 |
| Placebo Combined | Change From Baseline in Participant Assessment of Normal Function and Activity at Day 3 and 10 | Change at: Day 10 | 2.1 Units on a scale | Standard Error 0.09 |
Comparison: Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.04295% CI: [0, 0.49]ANOVA
Comparison: Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.11495% CI: [-0.04, 0.4]ANOVA
Comparison: Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms.p-value: 0.59895% CI: [-0.34, 0.2]ANOVA
Comparison: Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.83395% CI: [-0.24, 0.19]ANOVA
Comparison: Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.85395% CI: [-0.18, 0.22]ANOVA
Comparison: Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms.p-value: 0.73395% CI: [-0.2, 0.29]ANOVA
Secondary
Change From Baseline in Participant's Global Assessment of Ankle Injury at Day 3 and 10
Participant's global assessments of ankle injury was measured using 5-point scale: 1= Very Good (No symptoms and no limitations of normal activities), 2= Good (Mild symptoms and no limitation of normal activities), 3= Fair (Moderate symptoms and limitations of some normal activities), 4= Poor (Severe symptoms and inability to carry out most normal activities), 5= Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).
Time frame: Baseline, Day 3, 10
Population: The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Ibuprofen Twice Daily | Change From Baseline in Participant's Global Assessment of Ankle Injury at Day 3 and 10 | Change at: Day 3 | 0.7 units on a scale | Standard Error 0.09 |
| Ibuprofen Twice Daily | Change From Baseline in Participant's Global Assessment of Ankle Injury at Day 3 and 10 | Change at: Day 10 | 1.8 units on a scale | Standard Error 0.09 |
| Ibuprofen Thrice Daily | Change From Baseline in Participant's Global Assessment of Ankle Injury at Day 3 and 10 | Change at: Day 3 | 0.7 units on a scale | Standard Error 0.08 |
| Ibuprofen Thrice Daily | Change From Baseline in Participant's Global Assessment of Ankle Injury at Day 3 and 10 | Change at: Day 10 | 1.7 units on a scale | Standard Error 0.09 |
| Placebo Combined | Change From Baseline in Participant's Global Assessment of Ankle Injury at Day 3 and 10 | Change at: Day 3 | 0.6 units on a scale | Standard Error 0.06 |
| Placebo Combined | Change From Baseline in Participant's Global Assessment of Ankle Injury at Day 3 and 10 | Change at: Day 10 | 1.6 units on a scale | Standard Error 0.07 |
Comparison: Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebop-value: 0.30595% CI: [-0.1, 0.3]ANOVA
Comparison: Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.26195% CI: [-0.08, 0.29]ANOVA
Comparison: Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms.p-value: 0.99695% CI: [-0.22, 0.22]ANOVA
Comparison: Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.2195% CI: [-0.08, 0.36]ANOVA
Comparison: Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.55695% CI: [-0.14, 0.27]ANOVA
Comparison: Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms.p-value: 0.53495% CI: [-0.33, 0.17]ANOVA
Secondary
Change From Baseline in Physician Global Assessment of Ankle Injury at Day 3 and 10
The physician assessment of the severity of the ankle injury was based on the participant's individual signs and symptoms which included pain, swelling, tenderness and limitation of range of movement, and was measured using 6-point scale: 0= Normal (No signs or symptoms) , 1= Very mild (Very mild signs and symptoms), 2= Mild (Mild signs and symptoms), 3= Moderate (Moderate signs and symptoms), 4= Severe (Severe signs and symptoms), 5= Very severe (Very severe signs and symptoms). A higher score is indicative of lesser improvement. Change from baseline was calculated as baseline value minus post-treatment value.
Time frame: Baseline, Day 3, 10
Population: The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Ibuprofen Twice Daily | Change From Baseline in Physician Global Assessment of Ankle Injury at Day 3 and 10 | Change at: Day 3 | 0.7 units on a scale | Standard Error 0.08 |
| Ibuprofen Twice Daily | Change From Baseline in Physician Global Assessment of Ankle Injury at Day 3 and 10 | Change at: Day 10 | 1.8 units on a scale | Standard Error 0.09 |
| Ibuprofen Thrice Daily | Change From Baseline in Physician Global Assessment of Ankle Injury at Day 3 and 10 | Change at: Day 3 | 0.7 units on a scale | Standard Error 0.07 |
| Ibuprofen Thrice Daily | Change From Baseline in Physician Global Assessment of Ankle Injury at Day 3 and 10 | Change at: Day 10 | 2.0 units on a scale | Standard Error 0.09 |
| Placebo Combined | Change From Baseline in Physician Global Assessment of Ankle Injury at Day 3 and 10 | Change at: Day 3 | 0.8 units on a scale | Standard Error 0.06 |
| Placebo Combined | Change From Baseline in Physician Global Assessment of Ankle Injury at Day 3 and 10 | Change at: Day 10 | 2.0 units on a scale | Standard Error 0.06 |
Comparison: Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.35495% CI: [-0.27, 0.1]ANOVA
Comparison: Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.23795% CI: [-0.28, 0.07]ANOVA
Comparison: Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms.p-value: 0.87195% CI: [-0.23, 0.19]ANOVA
Comparison: Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.0595% CI: [-0.43, 0]ANOVA
Comparison: Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.6495% CI: [-0.25, 0.15]ANOVA
Comparison: Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms.p-value: 0.1895% CI: [-0.08, 0.41]ANOVA
Secondary
Number of Doses of Rescue Medication Used During the First 7 Days of Dosing
Participants received only acetaminophen 500 mg every 6 hours PRN as rescue medication during the course of the study.
Time frame: Baseline up to Day 7
Population: The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibuprofen Twice Daily | Number of Doses of Rescue Medication Used During the First 7 Days of Dosing | 1.7 Doses | Standard Deviation 3.83 |
| Ibuprofen Thrice Daily | Number of Doses of Rescue Medication Used During the First 7 Days of Dosing | 0.6 Doses | Standard Deviation 1.41 |
| Placebo Combined | Number of Doses of Rescue Medication Used During the First 7 Days of Dosing | 1.2 Doses | Standard Deviation 3.96 |
p-value: 0.479Cochran-Mantel-Haenszel
p-value: 0.279Cochran-Mantel-Haenszel
p-value: 0.129Cochran-Mantel-Haenszel
Secondary
Participant's Global Assessment of Medication at End of Study
Participants Global Assessment of Medication was used to rate the medication as a pain reliever. The responses of participants were recorded using 5-point scale: 1= Very Poor, 2= Poor, 3= Fair, 4= Good, 5= Very Good. The global assessment of medication scores for each question range from 0 to 5, giving a possible score range of 0 - 5, with higher scores indicating medication as a better pain reliever.
Time frame: Day 10
Population: The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment. Number of participants analyzed 'N' signifies those participants who were evaluable for the measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibuprofen Twice Daily | Participant's Global Assessment of Medication at End of Study | 3.8 Units on a scale | Standard Deviation 1.18 |
| Ibuprofen Thrice Daily | Participant's Global Assessment of Medication at End of Study | 4 Units on a scale | Standard Deviation 0.94 |
| Placebo Combined | Participant's Global Assessment of Medication at End of Study | 4 Units on a scale | Standard Deviation 1.03 |
Secondary
Percentage of Participants Taking Rescue Medication
Participants used only acetaminophen at a dose of 500 mg every 6 hours PRN as analgesia or rescue therapy during the course of the study. Participants who used acetaminophen were to record its use, and date and time of administration in the participant diary.
Time frame: Post first dose Day 1 up to Day 10
Population: The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ibuprofen Twice Daily | Percentage of Participants Taking Rescue Medication | 28.4 Percentage of participants |
| Ibuprofen Thrice Daily | Percentage of Participants Taking Rescue Medication | 18.8 Percentage of participants |
| Placebo Combined | Percentage of Participants Taking Rescue Medication | 25.7 Percentage of participants |
Secondary
Sum of Pain Intensity Difference at Rest and on Weight Bearing Over 6 Hours on Day 1 and Over 2 Hours on Day 3
PI at rest and on weight bearing was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID 0-6 was calculated as the time-weighted sum of PID scores over 6 hours on Day 1, with a total score ranges from -30 (higher pain relief) to 36 (lower pain relief). SPID 0-12 was calculated as the time weighted sum of PID scores over 2 hours on Day 3, with a total score ranges from -10 (higher pain relief) to 12 (lower pain relief). SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.
Time frame: Over 6 hours on Day 1, over 2 hours on Day 3
Population: The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Ibuprofen Twice Daily | Sum of Pain Intensity Difference at Rest and on Weight Bearing Over 6 Hours on Day 1 and Over 2 Hours on Day 3 | Weight Bearing over 2 Hours on Day 3 | 116.1 units on a scale | Standard Error 10.11 |
| Ibuprofen Twice Daily | Sum of Pain Intensity Difference at Rest and on Weight Bearing Over 6 Hours on Day 1 and Over 2 Hours on Day 3 | At Rest over 2 Hours on Day 3 | 109.6 units on a scale | Standard Error 9.54 |
| Ibuprofen Twice Daily | Sum of Pain Intensity Difference at Rest and on Weight Bearing Over 6 Hours on Day 1 and Over 2 Hours on Day 3 | At Rest over 6 Hours on Day 1 | 10.4 units on a scale | Standard Error 1.24 |
| Ibuprofen Twice Daily | Sum of Pain Intensity Difference at Rest and on Weight Bearing Over 6 Hours on Day 1 and Over 2 Hours on Day 3 | Weight Bearing over 6 Hours on Day 1 | 11.7 units on a scale | Standard Error 1.31 |
| Ibuprofen Thrice Daily | Sum of Pain Intensity Difference at Rest and on Weight Bearing Over 6 Hours on Day 1 and Over 2 Hours on Day 3 | At Rest over 2 Hours on Day 3 | 79.4 units on a scale | Standard Error 8.8 |
| Ibuprofen Thrice Daily | Sum of Pain Intensity Difference at Rest and on Weight Bearing Over 6 Hours on Day 1 and Over 2 Hours on Day 3 | At Rest over 6 Hours on Day 1 | 6.6 units on a scale | Standard Error 1.14 |
| Ibuprofen Thrice Daily | Sum of Pain Intensity Difference at Rest and on Weight Bearing Over 6 Hours on Day 1 and Over 2 Hours on Day 3 | Weight Bearing over 6 Hours on Day 1 | 9.4 units on a scale | Standard Error 1.2 |
| Ibuprofen Thrice Daily | Sum of Pain Intensity Difference at Rest and on Weight Bearing Over 6 Hours on Day 1 and Over 2 Hours on Day 3 | Weight Bearing over 2 Hours on Day 3 | 106.8 units on a scale | Standard Error 9.29 |
| Placebo Combined | Sum of Pain Intensity Difference at Rest and on Weight Bearing Over 6 Hours on Day 1 and Over 2 Hours on Day 3 | At Rest over 6 Hours on Day 1 | 8.4 units on a scale | Standard Error 0.86 |
| Placebo Combined | Sum of Pain Intensity Difference at Rest and on Weight Bearing Over 6 Hours on Day 1 and Over 2 Hours on Day 3 | Weight Bearing over 6 Hours on Day 1 | 9.9 units on a scale | Standard Error 0.91 |
| Placebo Combined | Sum of Pain Intensity Difference at Rest and on Weight Bearing Over 6 Hours on Day 1 and Over 2 Hours on Day 3 | Weight Bearing over 2 Hours on Day 3 | 102.4 units on a scale | Standard Error 7.06 |
| Placebo Combined | Sum of Pain Intensity Difference at Rest and on Weight Bearing Over 6 Hours on Day 1 and Over 2 Hours on Day 3 | At Rest over 2 Hours on Day 3 | 84.7 units on a scale | Standard Error 6.6 |
Comparison: At Rest over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.16695% CI: [-0.85, 4.95]ANOVA
Comparison: At Rest over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.19995% CI: [-4.42, 0.93]ANOVA
Comparison: At Rest over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.02295% CI: [-7.04, -0.56]ANOVA
Comparison: Weight Bearing over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.2695% CI: [-1.3, 4.79]ANOVA
Comparison: Weight Bearing over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.72995% CI: [-3.31, 2.32]ANOVA
Comparison: Weight Bearing over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.19695% CI: [-5.64, 1.16]ANOVA
Comparison: At Rest over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.0395% CI: [2.49, 47.28]ANOVA
Comparison: At Rest over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.01895% CI: [-55.24, -5.23]ANOVA
Comparison: At Rest over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.61195% CI: [-25.98, 15.29]ANOVA
Comparison: Weight Bearing over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.25195% CI: [-9.8, 37.36]ANOVA
Comparison: Weight Bearing over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.68995% CI: [-17.37, 26.26]ANOVA
Comparison: Weight Bearing over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.48695% CI: [-35.69, 17.01]ANOVA
Secondary
Sum of Pain Intensity Difference at Rest Over 24 Hours on Day 1 (SPID R24)
PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -240 (higher pain relief) to 96 (lower pain relief) for SPID at rest. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.
Time frame: 0 to 24 hours
Population: The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ibuprofen Twice Daily | Sum of Pain Intensity Difference at Rest Over 24 Hours on Day 1 (SPID R24) | 44.7 units on a scale | Standard Error 4.65 |
| Ibuprofen Thrice Daily | Sum of Pain Intensity Difference at Rest Over 24 Hours on Day 1 (SPID R24) | 29.4 units on a scale | Standard Error 4.29 |
| Placebo Combined | Sum of Pain Intensity Difference at Rest Over 24 Hours on Day 1 (SPID R24) | 34.7 units on a scale | Standard Error 3.22 |
Comparison: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.07295% CI: [-0.92, 20.91]ANOVA
Comparison: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.29695% CI: [-15.4, 4.7]ANOVA
Comparison: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms.p-value: 0.01495% CI: [-27.53, -3.16]ANOVA
Secondary
Sum of Pain Intensity Difference Scores at Rest and on Weight Bearing Over 7 Days
PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 7 days (168 hours). Total score ranges from -840 (higher pain relief) to 1008 (lower pain relief). SPID is a value of change from baseline. Pain score at baseline is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.
Time frame: Over 7 days (0-168 hours)
Population: The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Ibuprofen Twice Daily | Sum of Pain Intensity Difference Scores at Rest and on Weight Bearing Over 7 Days | At Rest: Over 7 Days | 472.5 Units on a scale | Standard Error 31.6 |
| Ibuprofen Twice Daily | Sum of Pain Intensity Difference Scores at Rest and on Weight Bearing Over 7 Days | Weight Bearing: Over 7 Days | 516.4 Units on a scale | Standard Error 34.52 |
| Ibuprofen Thrice Daily | Sum of Pain Intensity Difference Scores at Rest and on Weight Bearing Over 7 Days | Weight Bearing: Over 7 Days | 507.7 Units on a scale | Standard Error 31.7 |
| Ibuprofen Thrice Daily | Sum of Pain Intensity Difference Scores at Rest and on Weight Bearing Over 7 Days | At Rest: Over 7 Days | 396.6 Units on a scale | Standard Error 29.16 |
| Placebo Combined | Sum of Pain Intensity Difference Scores at Rest and on Weight Bearing Over 7 Days | At Rest: Over 7 Days | 384.8 Units on a scale | Standard Error 21.88 |
| Placebo Combined | Sum of Pain Intensity Difference Scores at Rest and on Weight Bearing Over 7 Days | Weight Bearing: Over 7 Days | 470.4 Units on a scale | Standard Error 24.09 |
Comparison: At Rest Over 7 days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.02195% CI: [13.48, 161.85]ANOVA
Comparison: At Rest Over 7 days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.73595% CI: [-56.59, 80.11]ANOVA
Comparison: At Rest Over 7 days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.07295% CI: [-158.73, 6.93]ANOVA
Comparison: Weight Bearing Over 7 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.26195% CI: [-34.43, 126.52]ANOVA
Comparison: Weight Bearing Over 7 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.32595% CI: [-37.13, 111.8]ANOVA
Comparison: Weight Bearing Over 7 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.p-value: 0.84995% CI: [-98.64, 81.22]ANOVA
Secondary
Sum of Pain Intensity Difference Scores at Rest Over 3 Days
PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 3 days (72 hours). Total score ranges from -360 (higher pain relief) to 432 (lower pain relief). SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.
Time frame: Over 3 Days (0-72 hours)
Population: The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ibuprofen Twice Daily | Sum of Pain Intensity Difference Scores at Rest Over 3 Days | 177.6 Units on a scale | Standard Error 13.9 |
| Ibuprofen Thrice Daily | Sum of Pain Intensity Difference Scores at Rest Over 3 Days | 131.1 Units on a scale | Standard Error 12.83 |
| Placebo Combined | Sum of Pain Intensity Difference Scores at Rest Over 3 Days | 139.0 Units on a scale | Standard Error 9.62 |
Comparison: At Rest Over 3 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.02195% CI: [5.9, 71.18]ANOVA
Comparison: At Rest Over 3 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.p-value: 0.60395% CI: [-38.02, 22.12]ANOVA
Comparison: At Rest Over 3 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.p-value: 0.01395% CI: [-82.93, -10.05]ANOVA
Secondary
Time to First Perceptible Relief and Meaningful Relief
Participants evaluated time to first perceptible relief by stopping a stopwatch labelled 'first perceptible relief' at moment participant first began to experience any relief, exact question asked was: Stop stopwatch when you first begin to feel any pain-relieving effect whatsoever of product; that is, when you first feel a little relief. First perceptible relief was considered confirmed by meaningful relief if participant achieved both first perceptible and meaningful relief by either pressing second stopwatch or by indicating that his/her first perceptible relief was also meaningful. For time to meaningful relief, exact question asked was: Stop this stopwatch when you have meaningful relief; that is, when relief from pain is meaningful to you. Stopwatches were active up to 3 hours after dosing or until stopped by participant, or rescue medication was administered.
Time frame: 0 to 3 hours on Day 1
Population: The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ibuprofen Twice Daily | Time to First Perceptible Relief and Meaningful Relief | First Perceptible Relief | 12.9 Minutes |
| Ibuprofen Twice Daily | Time to First Perceptible Relief and Meaningful Relief | Meaningful Relief | 41.6 Minutes |
| Ibuprofen Thrice Daily | Time to First Perceptible Relief and Meaningful Relief | First Perceptible Relief | 36.4 Minutes |
| Ibuprofen Thrice Daily | Time to First Perceptible Relief and Meaningful Relief | Meaningful Relief | NA Minutes |
| Placebo Combined | Time to First Perceptible Relief and Meaningful Relief | Meaningful Relief | 72.6 Minutes |
| Placebo Combined | Time to First Perceptible Relief and Meaningful Relief | First Perceptible Relief | 22.7 Minutes |
Comparison: Time to First Perceptible Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the Proportional Hazards (PH) model with treatment, BLPSR, and pooled site blocks.p-value: 0.01695% CI: [1.07, 1.97]Proportional Hazards Model
Comparison: Time to First Perceptible Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.p-value: 0.02295% CI: [0.53, 0.95]Proportional Hazards Model
Comparison: Time to First Perceptible Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.p-value: <0.00195% CI: [0.34, 0.69]Proportional Hazards Model
Comparison: Time to Meaningful Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.p-value: <0.00195% CI: [1.27, 2.51]Proportional Hazards Model
Comparison: Time to Meaningful Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.p-value: 0.00995% CI: [0.41, 0.88]Proportional Hazards Model
Comparison: Time to Meaningful Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.p-value: <0.00195% CI: [0.22, 0.52]Proportional Hazards Model
Secondary
Time to Rescue Medication After Initial Dose, and After Each Subsequent Dose
Participants used only acetaminophen at a dose of 500 milligram (mg) every 6 hours product as needed (PRN) as rescue medication during the course of the study. Participants who used acetaminophen were to record its use, and date and time of administration in the participant diary. Time to rescue medication after initial dose, after each subsequent dose, provided that in each dose interval at least 25% of the participants take rescue medication was analyzed using the proportional hazard model with site, treatment group, and baseline categorical ankle pain terms in the model.
Time frame: Post-Dose on Day 1 up to Day 10
Population: Data was not analyzed since \<20% participants used rescue medication.