Ankle Sprain
Conditions
Keywords
Ankle sprain, acute pain, NSAID, celecoxib,
Brief summary
To assess the efficacy of celecoxib loading dose of 400mg followed by 200 mg twice a day (BID) versus oral non-selective NSAIDs in acute pain due to ankle sprain.
Interventions
DRUGNon-selective NSAIDS
Non-selective NSAIDs administered at usual (standard) doses.
DRUGCelecoxib
celecoxib with an initial loading dose of 400 mg followed by 200 mg twice daily (BID) for up to 7 days.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with first acute ankle sprain episode in the last six months classified as grade I or II, confirmed by X-rays, according to the following definitions: * Grade I: When the ligament is stretched but not torn and the anterior talofibular ligament is usually involved. The anterior draw test is negative. * Grade II: Moderate sprains which usually result in partial tears af the ligaments, primarily the anterior talofibular and possibly the calcaneofibular ligament. Ligamentous laxity may be present and there is moderate swelling.
Exclusion criteria
* Patients who have a similar injury of the same joint within the last six months; or * clinical evidence of complete rupture of ankle ligaments (third degree sprain), or * requirements for bed rest, hospitalization, surgical intervention for the ankle injury; or * evidence of fractures; or non-removable full cast of any tipe; or * presence of bilateral occurrence of ankle injury or ipsilateral ankle and knee injury.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at Day 3 in Pain Visual Analog Scale (VAS) - Per Protocol Population | Baseline and day 3 | Assessment of ankle pain by VAS: 100 mm horizontal line with left end being No Pain & right end being Worst Possible Pain. Participants drew vertical line on horizontal scale to best reflect current pain on full weight bearing of injured ankle. Distance from left end of line to mark. Change: mean score at day 3 minus mean score at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Responding (Improving) - MITT Population | Days 2, 3 and 7 | The number of subjects showing a response: a decrease of at least 20 mm (that is improvement) on the pain visual analog scale (VAS) scale |
| Subject's Global Assessment of Ankle Injury | Days 2, 3 and 7 | Subject response to question: Considering all the ways your ankle injury affects you, how are you doing today? Scale: 5 point from 1 = very good (no symptoms and no limitation of normal activities) to 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). |
| Physician Global Assessment of Ankle Injury | Days 3 and 7 | Investigator evaluation of overall severity of ankle injury. Scale: 5 point from 1 = Very mild (very mild signs and symptoms of ankle sprain) to 5 =Very severe (very severe signs and symptoms of ankle sprain) |
| Pain Relief - MITT Population | Days 2, 3 and 7 | Subject's response to the statement My relief from starting pain is. Scale from 0 = None to 4 = Complete. |
| Subject Assessment of Normal Function / Activity | Days 2, 3 and 7 | Subject response to question: How does your ankle injury affect your walking and normal activity? Scale from 1 = Normal walking/activity and no pain to 5 = Severely restricted walking due to pain and can't resume normal activities (normal activities defined as all activity that a subject did on a routine basis, including work and recreation) |
| Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 1 | Days 1, 3 and 7 | m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period. Q1: Subject response to 'describe your pain at its worst in the last 24 hours'. Scale: 0 = no pain to 10 = pain as bad as you can imagine |
| Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 2 | Days 2, 3 and 7 | m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period. Q2: Subject response to 'describe your pain at its least in the last 24 hours'. Scale: 0 = no pain to 10 = pain as bad as you can imagine |
| Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 3 | Days 2, 3 and 7 | m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period. Q3: Subject response to 'describe your pain on the average'. Scale: 0 = no pain to 10 = pain as bad as you can imagine |
| Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 4 | Days 2, 3 and 7 | m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period. Q4: Subject response to 'how much pain you have right now'. Scale: 0 = no pain to 10 = pain as bad as you can imagine |
| Change From Baseline in Pain Visual Analog Scale (VAS) - Modified Intent to Treat Population | Baseline and days 2, 3 and 7 | Assessment of ankle pain by VAS: 100 mm horizontal line, left end being No Pain & right end being Worst Possible Pain. Participants drew vertical line on horizontal scale to best reflect current pain on full weight bearing of injured ankle. Distance from left end of line to mark. Change: mean score at observation minus mean score at baseline |
| Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5A | Days 2, 3 and 7 | m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period. Q5A: Subject response to 'how, during the past 24 hours, pain has interfered with your general activity. Scale: 0 = does not interfere to 10 = completely interferes |
| Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5B | Days 2, 3 and 7 | m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period. Q5B: Subject response to 'how, during the past 24 hours, pain has interfered with your mood'. Scale: 0 = does not interfere to 10 = completely interferes |
| Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5C | Days 2, 3 and 7 | m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period. Q5C: Subject response to 'how, during the past 24 hours, pain has interfered with your walking ability'. Scale: 0 = does not interfere to 10 = completely interferes |
| Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5D | Days 2, 3 and 7 | m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period. Q5D: Subject response to 'how, during the past 24 hours, pain has interfered with your normal work (work outside the home and housework)'. Scale: 0 = does not interfere to 10 = completely interferes |
| Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5E | Days 2, 3 and 7 | m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period. Q5E: Subject response to 'how, during the past 24 hours, pain has interfered with your relations with other people'. Scale: 0 = does not interfere to 10 = completely interferes |
| Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5F | Days 2, 3 and 7 | m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period. Q5F: Subject response to 'how, during the past 24 hours, pain has interfered with your sleep'. Scale: 0 = does not interfere to 10 = completely interferes |
| Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5G | Days 2, 3 and 7 | m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period. Q5G: Subject response to 'how, during the past 24 hours, pain has interfered with your enjoyment of life'. Scale: 0 = does not interfere to 10 = completely interferes |
| Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Index | Days 2, 3 and 7 | m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period. The pain interference index is the average of pain interference questions 5A to 5G. Scale: 0 = does not interfere to 10 = completely interferes |
| Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Index | Days 2, 3 and 7 | m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period. Pain severity index is the average of the pain severity questions 1 to 4. Scale: 0 = no pain to 10 = pain as bad as you can imagine |
Countries
Brazil, Costa Rica, Ecuador, Egypt, Jordan, Mexico, Panama, Peru
Participant flow
Recruitment details
Locations used were emergency rooms at orthopedic hospitals, general hospitals or private doctor's offices
Pre-assignment details
Subjects sustained ankle sprain with a pain rating of greater than or equal to 45mm on a visual analog scale on full weight bearing, no more than 48 hours prior to the first dose of study medication
Participants by arm
| Arm | Count |
|---|---|
| Celecoxib All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses. | 141 |
| nsNSAIDs All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days. | 137 |
| Total | 278 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | did not meet entrance criteria | 0 | 1 |
| Overall Study | Lack of Efficacy | 0 | 2 |
| Overall Study | Lost to Follow-up | 5 | 3 |
| Overall Study | Protocol Violation | 1 | 3 |
| Overall Study | subject entered at another site | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Celecoxib | nsNSAIDs | Total |
|---|---|---|---|
| Age, Continuous | 30.6 years | 30.4 years | 30.5 years |
| Sex: Female, Male Female | 56 Participants | 55 Participants | 111 Participants |
| Sex: Female, Male Male | 85 Participants | 82 Participants | 167 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / — | 17 / — |
| serious Total, serious adverse events | 0 / — | 2 / — |
Outcome results
Primary
Change From Baseline at Day 3 in Pain Visual Analog Scale (VAS) - Per Protocol Population
Assessment of ankle pain by VAS: 100 mm horizontal line with left end being No Pain & right end being Worst Possible Pain. Participants drew vertical line on horizontal scale to best reflect current pain on full weight bearing of injured ankle. Distance from left end of line to mark. Change: mean score at day 3 minus mean score at baseline
Time frame: Baseline and day 3
Population: Per protocol (PP) population included subjects who were randomized, received full loading dose of study medication on day 1 and took no prohibited medications up to and including day 3, had valid baseline and day 3 VAS scores and had no major protocol violations before or during the study (i.e. a subset of treated subjects).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib | Change From Baseline at Day 3 in Pain Visual Analog Scale (VAS) - Per Protocol Population | -44.88 scores on a scale | Standard Deviation 19.75 |
| nsNSAIDs | Change From Baseline at Day 3 in Pain Visual Analog Scale (VAS) - Per Protocol Population | -40.76 scores on a scale | Standard Deviation 18.91 |
Comparison: Least squares mean95% CI: [-0.76, 7.55]ANCOVA
Secondary
Change From Baseline in Pain Visual Analog Scale (VAS) - Modified Intent to Treat Population
Assessment of ankle pain by VAS: 100 mm horizontal line, left end being No Pain & right end being Worst Possible Pain. Participants drew vertical line on horizontal scale to best reflect current pain on full weight bearing of injured ankle. Distance from left end of line to mark. Change: mean score at observation minus mean score at baseline
Time frame: Baseline and days 2, 3 and 7
Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment (i.e. a subset of treated subjects).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib | Change From Baseline in Pain Visual Analog Scale (VAS) - Modified Intent to Treat Population | Day 2 | -29.25 scores on a scale | Standard Deviation 18.99 |
| Celecoxib | Change From Baseline in Pain Visual Analog Scale (VAS) - Modified Intent to Treat Population | Day 3 | -44.87 scores on a scale | Standard Deviation 19.51 |
| Celecoxib | Change From Baseline in Pain Visual Analog Scale (VAS) - Modified Intent to Treat Population | Day 7 | -61.17 scores on a scale | Standard Deviation 18.43 |
| nsNSAIDs | Change From Baseline in Pain Visual Analog Scale (VAS) - Modified Intent to Treat Population | Day 2 | -25.98 scores on a scale | Standard Deviation 18.21 |
| nsNSAIDs | Change From Baseline in Pain Visual Analog Scale (VAS) - Modified Intent to Treat Population | Day 3 | -40.75 scores on a scale | Standard Deviation 18.74 |
| nsNSAIDs | Change From Baseline in Pain Visual Analog Scale (VAS) - Modified Intent to Treat Population | Day 7 | -57.89 scores on a scale | Standard Deviation 18.84 |
Comparison: Day 2 Least squares mean95% CI: [-0.89, 7.08]ANCOVA
Comparison: Day 3 Least squares mean95% CI: [-0.55, 7.48]ANCOVA
Comparison: Day 7 Least squares mean95% CI: [-0.91, 6.42]ANCOVA
Secondary
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Index
m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period. The pain interference index is the average of pain interference questions 5A to 5G. Scale: 0 = does not interfere to 10 = completely interferes
Time frame: Days 2, 3 and 7
Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Index | Day 7 (N = 133, 125) | 1.28 scores on a scale | Standard Deviation 1.81 |
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Index | Day 2 (N = 134, 133) | 4.07 scores on a scale | Standard Deviation 2.34 |
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Index | Day 3 (N = 135, 131) | 2.79 scores on a scale | Standard Deviation 2.15 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Index | Day 3 (N = 135, 131) | 2.83 scores on a scale | Standard Deviation 2.07 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Index | Day 7 (N = 133, 125) | 1.33 scores on a scale | Standard Deviation 1.54 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Index | Day 2 (N = 134, 133) | 4.01 scores on a scale | Standard Deviation 2.12 |
Comparison: Day 2 Least squares meanp-value: 0.88795% CI: [-0.54, 0.45]ANCOVA
Comparison: Day 3 Least squares meanp-value: 0.88995% CI: [-0.43, 0.51]ANCOVA
Comparison: Day 7 Least squares meanp-value: 0.73895% CI: [-0.3, 0.47]ANCOVA
Secondary
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5A
m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period. Q5A: Subject response to 'how, during the past 24 hours, pain has interfered with your general activity. Scale: 0 = does not interfere to 10 = completely interferes
Time frame: Days 2, 3 and 7
Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5A | Day 2 (N = 134, 133) | 5.40 scores on a scale | Standard Deviation 2.52 |
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5A | Day 3 (N = 135, 131) | 3.65 scores on a scale | Standard Deviation 2.64 |
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5A | Day 7 (N = 133, 125) | 1.78 scores on a scale | Standard Deviation 2.13 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5A | Day 2 (N = 134, 133) | 5.37 scores on a scale | Standard Deviation 2.62 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5A | Day 3 (N = 135, 131) | 4.07 scores on a scale | Standard Deviation 2.6 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5A | Day 7 (N = 133, 125) | 1.90 scores on a scale | Standard Deviation 1.94 |
Comparison: Day 2 Least squares meanp-value: 0.95495% CI: [-0.64, 0.53]ANCOVA
Comparison: Day 3 Least squares meanp-value: 0.17295% CI: [-0.19, 1.02]ANCOVA
Comparison: Day 7 Least squares meanp-value: 0.54195% CI: [-0.3, 0.62]ANCOVA
Secondary
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5B
m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period. Q5B: Subject response to 'how, during the past 24 hours, pain has interfered with your mood'. Scale: 0 = does not interfere to 10 = completely interferes
Time frame: Days 2, 3 and 7
Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5B | Day 2 (N = 134, 133) | 3.72 scores on a scale | Standard Deviation 2.95 |
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5B | Day 3 (N = 135, 131) | 2.43 scores on a scale | Standard Deviation 2.41 |
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5B | Day 7 (N = 133, 125) | 1.17 scores on a scale | Standard Deviation 2.06 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5B | Day 2 (N = 134, 133) | 3.64 scores on a scale | Standard Deviation 2.87 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5B | Day 3 (N = 135, 131) | 2.38 scores on a scale | Standard Deviation 2.6 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5B | Day 7 (N = 133, 125) | 1.26 scores on a scale | Standard Deviation 2.01 |
Comparison: Day 2 Least squares meanp-value: 0.92495% CI: [-0.75, 0.58]ANCOVA
Comparison: Day 3 Least squares meanp-value: 0.89895% CI: [-0.62, 0.51]ANCOVA
Comparison: Day 7 Least squares meanp-value: 0.65595% CI: [-0.33, 0.6]ANCOVA
Secondary
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5C
m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period. Q5C: Subject response to 'how, during the past 24 hours, pain has interfered with your walking ability'. Scale: 0 = does not interfere to 10 = completely interferes
Time frame: Days 2, 3 and 7
Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5C | Day 2 (N = 134, 133) | 5.10 scores on a scale | Standard Deviation 2.76 |
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5C | Day 3 (N = 135, 131) | 3.58 scores on a scale | Standard Deviation 2.62 |
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5C | Day 7 (N = 133, 125) | 1.65 scores on a scale | Standard Deviation 2.19 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5C | Day 2 (N = 134, 133) | 5.11 scores on a scale | Standard Deviation 2.74 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5C | Day 3 (N = 135, 131) | 3.69 scores on a scale | Standard Deviation 2.67 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5C | Day 7 (N = 133, 125) | 1.62 scores on a scale | Standard Deviation 1.93 |
Comparison: Day 2 Least squares meanp-value: 0.92995% CI: [-0.59, 0.62]ANCOVA
Comparison: Day 3 Least squares meanp-value: 0.71295% CI: [-0.5, 0.71]ANCOVA
Comparison: Day 7 Least squares meanp-value: 0.99395% CI: [-0.44, 0.51]ANCOVA
Secondary
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5D
m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period. Q5D: Subject response to 'how, during the past 24 hours, pain has interfered with your normal work (work outside the home and housework)'. Scale: 0 = does not interfere to 10 = completely interferes
Time frame: Days 2, 3 and 7
Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5D | Day 3 (N = 135, 131) | 4.04 scores on a scale | Standard Deviation 2.92 |
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5D | Day 2 (N = 134, 133) | 5.29 scores on a scale | Standard Deviation 2.95 |
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5D | Day 7 (N = 133, 125) | 1.84 scores on a scale | Standard Deviation 2.42 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5D | Day 2 (N = 134, 133) | 5.39 scores on a scale | Standard Deviation 2.76 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5D | Day 3 (N = 135, 131) | 4.04 scores on a scale | Standard Deviation 2.88 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5D | Day 7 (N = 133, 125) | 1.87 scores on a scale | Standard Deviation 2.11 |
Comparison: Day 2 Least squares meanp-value: 0.77995% CI: [-0.53, 0.75]ANCOVA
Comparison: Day 3 Least squares meanp-value: 0.97295% CI: [-0.69, 0.65]ANCOVA
Comparison: Day 7 Least squares meanp-value: 0.84495% CI: [-0.47, 0.61]ANCOVA
Secondary
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5E
m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period. Q5E: Subject response to 'how, during the past 24 hours, pain has interfered with your relations with other people'. Scale: 0 = does not interfere to 10 = completely interferes
Time frame: Days 2, 3 and 7
Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5E | Day 2 (N = 134, 133) | 2.70 scores on a scale | Standard Deviation 2.78 |
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5E | Day 3 (N = 135, 131) | 1.81 scores on a scale | Standard Deviation 2.26 |
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5E | Day 7 (N = 133, 125) | 0.80 scores on a scale | Standard Deviation 1.7 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5E | Day 3 (N = 135, 131) | 1.69 scores on a scale | Standard Deviation 2.26 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5E | Day 2 (N = 134, 133) | 2.67 scores on a scale | Standard Deviation 2.68 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5E | Day 7 (N = 133, 125) | 0.78 scores on a scale | Standard Deviation 1.48 |
Comparison: Day 2 Least squares meanp-value: 0.94495% CI: [-0.63, 0.6]ANCOVA
Comparison: Day 3 Least squares meanp-value: 0.65495% CI: [-0.62, 0.38]ANCOVA
Comparison: Day 7 Least squares meanp-value: 0.95295% CI: [-0.36, 0.39]ANCOVA
Secondary
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5F
m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period. Q5F: Subject response to 'how, during the past 24 hours, pain has interfered with your sleep'. Scale: 0 = does not interfere to 10 = completely interferes
Time frame: Days 2, 3 and 7
Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5F | Day 2 (N = 134, 133) | 2.97 scores on a scale | Standard Deviation 2.88 |
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5F | Day 3 (N = 135, 131) | 1.90 scores on a scale | Standard Deviation 2.4 |
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5F | Day 7 (N = 133, 125) | 0.68 scores on a scale | Standard Deviation 1.77 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5F | Day 2 (N = 134, 133) | 2.87 scores on a scale | Standard Deviation 2.64 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5F | Day 3 (N = 135, 131) | 1.86 scores on a scale | Standard Deviation 2.28 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5F | Day 7 (N = 133, 125) | 0.82 scores on a scale | Standard Deviation 1.61 |
Comparison: Day 2 Least squares meanp-value: 0.84295% CI: [-0.65, 0.59]ANCOVA
Comparison: Day 3 Least squares meanp-value: 0.82895% CI: [-0.57, 0.49]ANCOVA
Comparison: Day 7 Least squares meanp-value: 0.54295% CI: [-0.3, 0.53]ANCOVA
Secondary
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5G
m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period. Q5G: Subject response to 'how, during the past 24 hours, pain has interfered with your enjoyment of life'. Scale: 0 = does not interfere to 10 = completely interferes
Time frame: Days 2, 3 and 7
Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5G | Day 2 (N = 134, 133) | 3.33 scores on a scale | Standard Deviation 3.17 |
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5G | Day 3 (N = 135, 131) | 2.13 scores on a scale | Standard Deviation 2.69 |
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5G | Day 7 (N = 133, 125) | 1.07 scores on a scale | Standard Deviation 1.98 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5G | Day 2 (N = 134, 133) | 2.99 scores on a scale | Standard Deviation 2.81 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5G | Day 3 (N = 135, 131) | 2.06 scores on a scale | Standard Deviation 2.48 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5G | Day 7 (N = 133, 125) | 1.10 scores on a scale | Standard Deviation 1.8 |
Comparison: Day 2 Least squares meanp-value: 0.40495% CI: [-0.92, 0.42]ANCOVA
Comparison: Day 3 Least squares meanp-value: 0.81695% CI: [-0.53, 0.58]ANCOVA
Comparison: Day 7 Least squares meanp-value: 0.83795% CI: [-0.37, 0.52]ANCOVA
Secondary
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Index
m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period. Pain severity index is the average of the pain severity questions 1 to 4. Scale: 0 = no pain to 10 = pain as bad as you can imagine
Time frame: Days 2, 3 and 7
Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Index | Day 3 (N = 135, 131) | 2.84 scores on a scale | Standard Deviation 1.61 |
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Index | Day 2 (N = 134, 133) | 4.24 scores on a scale | Standard Deviation 1.66 |
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Index | Day 7 (N = 133, 125) | 1.37 scores on a scale | Standard Deviation 1.47 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Index | Day 2 (N = 134, 133) | 4.48 scores on a scale | Standard Deviation 1.84 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Index | Day 3 (N = 135, 131) | 3.26 scores on a scale | Standard Deviation 1.57 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Index | Day 7 (N = 133, 125) | 1.68 scores on a scale | Standard Deviation 1.44 |
Comparison: Day 2 Least squares meanp-value: 0.22995% CI: [-0.17, 0.6]ANCOVA
Comparison: Day 3 Least squares meanp-value: 0.02795% CI: [0.05, 0.75]ANCOVA
Comparison: Day 7 Least squares meanp-value: 0.0795% CI: [0.01, 0.65]ANCOVA
Secondary
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 1
m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period. Q1: Subject response to 'describe your pain at its worst in the last 24 hours'. Scale: 0 = no pain to 10 = pain as bad as you can imagine
Time frame: Days 1, 3 and 7
Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 1 | Day 2 (N = 134, 133) | 5.71 scores on a scale | Standard Deviation 2.04 |
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 1 | Day 3 (N = 135, 131) | 3.81 scores on a scale | Standard Deviation 1.84 |
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 1 | Day 7 (N = 133, 125) | 2.08 scores on a scale | Standard Deviation 1.93 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 1 | Day 2 (N = 134, 133) | 5.90 scores on a scale | Standard Deviation 2.06 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 1 | Day 3 (N = 135, 131) | 4.44 scores on a scale | Standard Deviation 1.91 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 1 | Day 7 (N = 133, 125) | 2.38 scores on a scale | Standard Deviation 1.78 |
Comparison: Day 2 Least squares meanp-value: 0.39595% CI: [-0.33, 0.62]ANCOVA
Comparison: Day 3 Least squares meanp-value: 0.00495% CI: [0.18, 1.04]ANCOVA
Comparison: Day 7 Least squares meanp-value: 0.12295% CI: [-0.08, 0.77]ANCOVA
Secondary
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 2
m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period. Q2: Subject response to 'describe your pain at its least in the last 24 hours'. Scale: 0 = no pain to 10 = pain as bad as you can imagine
Time frame: Days 2, 3 and 7
Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 2 | Day 2 (N = 133, 133) | 3.25 scores on a scale | Standard Deviation 1.83 |
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 2 | Day 3 (N = 135, 131) | 2.07 scores on a scale | Standard Deviation 1.68 |
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 2 | Day 7 (N = 133, 125) | 0.83 scores on a scale | Standard Deviation 1.26 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 2 | Day 2 (N = 133, 133) | 3.36 scores on a scale | Standard Deviation 1.88 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 2 | Day 3 (N = 135, 131) | 2.40 scores on a scale | Standard Deviation 1.64 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 2 | Day 7 (N = 133, 125) | 1.16 scores on a scale | Standard Deviation 1.43 |
Comparison: Day 2 Least squares meanp-value: 0.60495% CI: [-0.32, 0.49]ANCOVA
Comparison: Day 3 Least squares meanp-value: 0.12495% CI: [-0.07, 0.63]ANCOVA
Comparison: Day 7 Least squares meanp-value: 0.06295% CI: [0.03, 0.61]ANCOVA
Secondary
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 3
m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period. Q3: Subject response to 'describe your pain on the average'. Scale: 0 = no pain to 10 = pain as bad as you can imagine
Time frame: Days 2, 3 and 7
Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 3 | Day 2 (N = 134, 133) | 4.34 scores on a scale | Standard Deviation 1.79 |
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 3 | Day 3 (N = 135, 131) | 2.90 scores on a scale | Standard Deviation 1.7 |
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 3 | Day 7 (N = 133, 125) | 1.41 scores on a scale | Standard Deviation 1.56 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 3 | Day 2 (N = 134, 133) | 4.41 scores on a scale | Standard Deviation 1.9 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 3 | Day 3 (N = 135, 131) | 3.26 scores on a scale | Standard Deviation 1.63 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 3 | Day 7 (N = 133, 125) | 1.74 scores on a scale | Standard Deviation 1.53 |
Comparison: Day 2 Least squares meanp-value: 0.70595% CI: [-0.36, 0.47]ANCOVA
Comparison: Day 3 Least squares meanp-value: 0.06495% CI: [-0.01, 0.73]ANCOVA
Comparison: Day 7 Least squares meanp-value: 0.07495% CI: [-0.01, 0.68]ANCOVA
Secondary
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 4
m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period. Q4: Subject response to 'how much pain you have right now'. Scale: 0 = no pain to 10 = pain as bad as you can imagine
Time frame: Days 2, 3 and 7
Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 4 | Day 2 (N = 134, 133) | 3.64 scores on a scale | Standard Deviation 2.05 |
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 4 | Day 3 (N =135, 131) | 2.58 scores on a scale | Standard Deviation 1.81 |
| Celecoxib | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 4 | Day 7 (N = 133, 125) | 1.14 scores on a scale | Standard Deviation 1.56 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 4 | Day 2 (N = 134, 133) | 4.23 scores on a scale | Standard Deviation 2.26 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 4 | Day 3 (N =135, 131) | 2.92 scores on a scale | Standard Deviation 1.78 |
| nsNSAIDs | Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 4 | Day 7 (N = 133, 125) | 1.43 scores on a scale | Standard Deviation 1.55 |
Comparison: Day 2 Least squares meanp-value: 0.01795% CI: [0.11, 1.05]ANCOVA
Comparison: Day 3 Least squares meanp-value: 0.10895% CI: [-0.05, 0.74]ANCOVA
Comparison: Day 7 Least squares meanp-value: 0.11795% CI: [-0.01, 0.66]ANCOVA
Secondary
Number of Subjects Responding (Improving) - MITT Population
The number of subjects showing a response: a decrease of at least 20 mm (that is improvement) on the pain visual analog scale (VAS) scale
Time frame: Days 2, 3 and 7
Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment (i.e. a subset of treated subjects).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib | Number of Subjects Responding (Improving) - MITT Population | Day 2 - response (N=134, 133) | 91 participants |
| Celecoxib | Number of Subjects Responding (Improving) - MITT Population | Day 2 - no response | 43 participants |
| Celecoxib | Number of Subjects Responding (Improving) - MITT Population | Day 3 - response (N=135, 131) | 124 participants |
| Celecoxib | Number of Subjects Responding (Improving) - MITT Population | Day 3 - no response | 11 participants |
| Celecoxib | Number of Subjects Responding (Improving) - MITT Population | Day 7 - response (N=133, 125) | 129 participants |
| Celecoxib | Number of Subjects Responding (Improving) - MITT Population | Day 7 - no response | 4 participants |
| nsNSAIDs | Number of Subjects Responding (Improving) - MITT Population | Day 7 - response (N=133, 125) | 120 participants |
| nsNSAIDs | Number of Subjects Responding (Improving) - MITT Population | Day 2 - response (N=134, 133) | 79 participants |
| nsNSAIDs | Number of Subjects Responding (Improving) - MITT Population | Day 3 - no response | 15 participants |
| nsNSAIDs | Number of Subjects Responding (Improving) - MITT Population | Day 2 - no response | 54 participants |
| nsNSAIDs | Number of Subjects Responding (Improving) - MITT Population | Day 7 - no response | 5 participants |
| nsNSAIDs | Number of Subjects Responding (Improving) - MITT Population | Day 3 - response (N=135, 131) | 116 participants |
Comparison: Day 2p-value: 0.1591Regression, Logistic
Comparison: Day 3p-value: 0.3995Regression, Logistic
Comparison: Day 7p-value: 0.6805Regression, Logistic
Secondary
Pain Relief - MITT Population
Subject's response to the statement My relief from starting pain is. Scale from 0 = None to 4 = Complete.
Time frame: Days 2, 3 and 7
Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib | Pain Relief - MITT Population | Day 7 -Complete | 42 participants |
| Celecoxib | Pain Relief - MITT Population | Day 2 - None (N=135, 132) | 8 participants |
| Celecoxib | Pain Relief - MITT Population | Day 2 - A little | 25 participants |
| Celecoxib | Pain Relief - MITT Population | Day 2 - Some | 49 participants |
| Celecoxib | Pain Relief - MITT Population | Day 2 - A lot | 52 participants |
| Celecoxib | Pain Relief - MITT Population | Day 2 -Complete | 1 participants |
| Celecoxib | Pain Relief - MITT Population | Day 3 - None (N=135, 131) | 0 participants |
| Celecoxib | Pain Relief - MITT Population | Day 3 - A little | 15 participants |
| Celecoxib | Pain Relief - MITT Population | Day 3 - Some | 33 participants |
| Celecoxib | Pain Relief - MITT Population | Day 3 - A lot | 84 participants |
| Celecoxib | Pain Relief - MITT Population | Day 3 -Complete | 3 participants |
| Celecoxib | Pain Relief - MITT Population | Day 7 - None (N=133, 125) | 1 participants |
| Celecoxib | Pain Relief - MITT Population | Day 7 - A little | 6 participants |
| Celecoxib | Pain Relief - MITT Population | Day 7 - Some | 7 participants |
| Celecoxib | Pain Relief - MITT Population | Day 7 - A lot | 77 participants |
| nsNSAIDs | Pain Relief - MITT Population | Day 7 -Complete | 26 participants |
| nsNSAIDs | Pain Relief - MITT Population | Day 3 - Some | 46 participants |
| nsNSAIDs | Pain Relief - MITT Population | Day 2 - None (N=135, 132) | 5 participants |
| nsNSAIDs | Pain Relief - MITT Population | Day 7 - A little | 3 participants |
| nsNSAIDs | Pain Relief - MITT Population | Day 2 - A little | 33 participants |
| nsNSAIDs | Pain Relief - MITT Population | Day 3 - A lot | 60 participants |
| nsNSAIDs | Pain Relief - MITT Population | Day 2 - Some | 52 participants |
| nsNSAIDs | Pain Relief - MITT Population | Day 7 - A lot | 80 participants |
| nsNSAIDs | Pain Relief - MITT Population | Day 2 - A lot | 42 participants |
| nsNSAIDs | Pain Relief - MITT Population | Day 3 -Complete | 3 participants |
| nsNSAIDs | Pain Relief - MITT Population | Day 2 -Complete | 0 participants |
| nsNSAIDs | Pain Relief - MITT Population | Day 7 - Some | 15 participants |
| nsNSAIDs | Pain Relief - MITT Population | Day 3 - None (N=135, 131) | 1 participants |
| nsNSAIDs | Pain Relief - MITT Population | Day 7 - None (N=133, 125) | 1 participants |
| nsNSAIDs | Pain Relief - MITT Population | Day 3 - A little | 21 participants |
Comparison: Day 2p-value: 0.29Cochran-Mantel-Haenszel
Comparison: Day 3p-value: 0.0157Cochran-Mantel-Haenszel
Comparison: Day 7p-value: 0.1206Cochran-Mantel-Haenszel
Secondary
Physician Global Assessment of Ankle Injury
Investigator evaluation of overall severity of ankle injury. Scale: 5 point from 1 = Very mild (very mild signs and symptoms of ankle sprain) to 5 =Very severe (very severe signs and symptoms of ankle sprain)
Time frame: Days 3 and 7
Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib | Physician Global Assessment of Ankle Injury | Day 3 - mild | 71 participants |
| Celecoxib | Physician Global Assessment of Ankle Injury | Day 3 - very severe | 1 participants |
| Celecoxib | Physician Global Assessment of Ankle Injury | Day 3 - very mild (N=134, 131) | 20 participants |
| Celecoxib | Physician Global Assessment of Ankle Injury | Day 7 - very mild (N=132, 125) | 87 participants |
| Celecoxib | Physician Global Assessment of Ankle Injury | Day 7 - moderate | 7 participants |
| Celecoxib | Physician Global Assessment of Ankle Injury | Day 7 - mild | 38 participants |
| Celecoxib | Physician Global Assessment of Ankle Injury | Day 7 - severe | 0 participants |
| Celecoxib | Physician Global Assessment of Ankle Injury | Day 3 - severe | 2 participants |
| Celecoxib | Physician Global Assessment of Ankle Injury | Day 7 - very severe | 0 participants |
| Celecoxib | Physician Global Assessment of Ankle Injury | Day 3 - moderate | 40 participants |
| nsNSAIDs | Physician Global Assessment of Ankle Injury | Day 7 - very severe | 0 participants |
| nsNSAIDs | Physician Global Assessment of Ankle Injury | Day 7 - mild | 47 participants |
| nsNSAIDs | Physician Global Assessment of Ankle Injury | Day 7 - moderate | 7 participants |
| nsNSAIDs | Physician Global Assessment of Ankle Injury | Day 3 - very mild (N=134, 131) | 12 participants |
| nsNSAIDs | Physician Global Assessment of Ankle Injury | Day 3 - mild | 79 participants |
| nsNSAIDs | Physician Global Assessment of Ankle Injury | Day 3 - moderate | 38 participants |
| nsNSAIDs | Physician Global Assessment of Ankle Injury | Day 3 - severe | 2 participants |
| nsNSAIDs | Physician Global Assessment of Ankle Injury | Day 3 - very severe | 0 participants |
| nsNSAIDs | Physician Global Assessment of Ankle Injury | Day 7 - very mild (N=132, 125) | 70 participants |
| nsNSAIDs | Physician Global Assessment of Ankle Injury | Day 7 - severe | 1 participants |
Comparison: Day 3p-value: 0.7223Cochran-Mantel-Haenszel
Comparison: Day 7p-value: 0.0541Cochran-Mantel-Haenszel
Secondary
Subject Assessment of Normal Function / Activity
Subject response to question: How does your ankle injury affect your walking and normal activity? Scale from 1 = Normal walking/activity and no pain to 5 = Severely restricted walking due to pain and can't resume normal activities (normal activities defined as all activity that a subject did on a routine basis, including work and recreation)
Time frame: Days 2, 3 and 7
Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib | Subject Assessment of Normal Function / Activity | Day 3 - moderately restricted | 14 participants |
| Celecoxib | Subject Assessment of Normal Function / Activity | Day 2 - normal no pain (N =135, 133) | 5 participants |
| Celecoxib | Subject Assessment of Normal Function / Activity | Day 2 - normal with pain | 40 participants |
| Celecoxib | Subject Assessment of Normal Function / Activity | Day 2 - mildly restricted | 59 participants |
| Celecoxib | Subject Assessment of Normal Function / Activity | Day 2 - moderately restricted | 19 participants |
| Celecoxib | Subject Assessment of Normal Function / Activity | Day 2 - severely restricted | 12 participants |
| Celecoxib | Subject Assessment of Normal Function / Activity | Day 3 - normal no pain (N = 135, 131) | 18 participants |
| Celecoxib | Subject Assessment of Normal Function / Activity | Day 3 - normal with pain | 52 participants |
| Celecoxib | Subject Assessment of Normal Function / Activity | Day 3 - mildly restricted | 49 participants |
| Celecoxib | Subject Assessment of Normal Function / Activity | Day 3 - severely restricted | 2 participants |
| Celecoxib | Subject Assessment of Normal Function / Activity | Day 7 - normal no pain (N = 133, 125) | 62 participants |
| Celecoxib | Subject Assessment of Normal Function / Activity | Day 7 - normal with pain | 55 participants |
| Celecoxib | Subject Assessment of Normal Function / Activity | Day 7 - mildly restricted | 11 participants |
| Celecoxib | Subject Assessment of Normal Function / Activity | Day 7 - moderately restricted | 4 participants |
| Celecoxib | Subject Assessment of Normal Function / Activity | Day 7 - severely restricted | 1 participants |
| nsNSAIDs | Subject Assessment of Normal Function / Activity | Day 7 - severely restricted | 3 participants |
| nsNSAIDs | Subject Assessment of Normal Function / Activity | Day 3 - moderately restricted | 11 participants |
| nsNSAIDs | Subject Assessment of Normal Function / Activity | Day 3 - severely restricted | 4 participants |
| nsNSAIDs | Subject Assessment of Normal Function / Activity | Day 3 - normal with pain | 46 participants |
| nsNSAIDs | Subject Assessment of Normal Function / Activity | Day 2 - normal no pain (N =135, 133) | 2 participants |
| nsNSAIDs | Subject Assessment of Normal Function / Activity | Day 7 - normal with pain | 68 participants |
| nsNSAIDs | Subject Assessment of Normal Function / Activity | Day 2 - normal with pain | 30 participants |
| nsNSAIDs | Subject Assessment of Normal Function / Activity | Day 3 - mildly restricted | 57 participants |
| nsNSAIDs | Subject Assessment of Normal Function / Activity | Day 2 - mildly restricted | 55 participants |
| nsNSAIDs | Subject Assessment of Normal Function / Activity | Day 7 - moderately restricted | 3 participants |
| nsNSAIDs | Subject Assessment of Normal Function / Activity | Day 2 - moderately restricted | 39 participants |
| nsNSAIDs | Subject Assessment of Normal Function / Activity | Day 7 - mildly restricted | 8 participants |
| nsNSAIDs | Subject Assessment of Normal Function / Activity | Day 2 - severely restricted | 7 participants |
| nsNSAIDs | Subject Assessment of Normal Function / Activity | Day 7 - normal no pain (N = 133, 125) | 43 participants |
| nsNSAIDs | Subject Assessment of Normal Function / Activity | Day 3 - normal no pain (N = 135, 131) | 13 participants |
Comparison: Day 2p-value: 0.0846Cochran-Mantel-Haenszel
Comparison: Day 3p-value: 0.3041Cochran-Mantel-Haenszel
Comparison: Day 7p-value: 0.1216Cochran-Mantel-Haenszel
Secondary
Subject's Global Assessment of Ankle Injury
Subject response to question: Considering all the ways your ankle injury affects you, how are you doing today? Scale: 5 point from 1 = very good (no symptoms and no limitation of normal activities) to 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities).
Time frame: Days 2, 3 and 7
Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib | Subject's Global Assessment of Ankle Injury | Day 2- Very poor (very severe symptoms) | 1 participants |
| Celecoxib | Subject's Global Assessment of Ankle Injury | Day 3 - Poor (severe symptoms) | 5 participants |
| Celecoxib | Subject's Global Assessment of Ankle Injury | Day 2 - Good (mild symptoms) | 40 participants |
| Celecoxib | Subject's Global Assessment of Ankle Injury | Day 3 - Very poor (very severe symptoms) | 0 participants |
| Celecoxib | Subject's Global Assessment of Ankle Injury | Day 3 - Very good (no symptoms) (N=135, 131) | 8 participants |
| Celecoxib | Subject's Global Assessment of Ankle Injury | Day 7 - Very good (no symptoms) (N=133, 125) | 53 participants |
| Celecoxib | Subject's Global Assessment of Ankle Injury | Day 2 - Poor (severe symptoms) | 17 participants |
| Celecoxib | Subject's Global Assessment of Ankle Injury | Day 7 - Good (mild symptoms) | 61 participants |
| Celecoxib | Subject's Global Assessment of Ankle Injury | Day 3 - Good (mild symptoms) | 68 participants |
| Celecoxib | Subject's Global Assessment of Ankle Injury | Day 7 - Fair (moderate symptoms) | 17 participants |
| Celecoxib | Subject's Global Assessment of Ankle Injury | Day 2 - Fair (moderate symptoms) | 76 participants |
| Celecoxib | Subject's Global Assessment of Ankle Injury | Day 7 - Poor (severe symptoms) | 2 participants |
| Celecoxib | Subject's Global Assessment of Ankle Injury | Day 3 - Fair (moderate symptoms) | 54 participants |
| Celecoxib | Subject's Global Assessment of Ankle Injury | Day 7 - Very poor (very severe symptoms) | 0 participants |
| Celecoxib | Subject's Global Assessment of Ankle Injury | Day 2 - Very good (no symptoms) (N=135, 133) | 1 participants |
| nsNSAIDs | Subject's Global Assessment of Ankle Injury | Day 7 - Very poor (very severe symptoms) | 0 participants |
| nsNSAIDs | Subject's Global Assessment of Ankle Injury | Day 2 - Very good (no symptoms) (N=135, 133) | 1 participants |
| nsNSAIDs | Subject's Global Assessment of Ankle Injury | Day 2 - Good (mild symptoms) | 31 participants |
| nsNSAIDs | Subject's Global Assessment of Ankle Injury | Day 2 - Fair (moderate symptoms) | 80 participants |
| nsNSAIDs | Subject's Global Assessment of Ankle Injury | Day 2 - Poor (severe symptoms) | 19 participants |
| nsNSAIDs | Subject's Global Assessment of Ankle Injury | Day 2- Very poor (very severe symptoms) | 2 participants |
| nsNSAIDs | Subject's Global Assessment of Ankle Injury | Day 3 - Very good (no symptoms) (N=135, 131) | 6 participants |
| nsNSAIDs | Subject's Global Assessment of Ankle Injury | Day 3 - Good (mild symptoms) | 55 participants |
| nsNSAIDs | Subject's Global Assessment of Ankle Injury | Day 3 - Fair (moderate symptoms) | 63 participants |
| nsNSAIDs | Subject's Global Assessment of Ankle Injury | Day 3 - Poor (severe symptoms) | 7 participants |
| nsNSAIDs | Subject's Global Assessment of Ankle Injury | Day 3 - Very poor (very severe symptoms) | 0 participants |
| nsNSAIDs | Subject's Global Assessment of Ankle Injury | Day 7 - Very good (no symptoms) (N=133, 125) | 37 participants |
| nsNSAIDs | Subject's Global Assessment of Ankle Injury | Day 7 - Good (mild symptoms) | 63 participants |
| nsNSAIDs | Subject's Global Assessment of Ankle Injury | Day 7 - Fair (moderate symptoms) | 21 participants |
| nsNSAIDs | Subject's Global Assessment of Ankle Injury | Day 7 - Poor (severe symptoms) | 4 participants |
Comparison: Day 2p-value: 0.2411Cochran-Mantel-Haenszel
Comparison: Day 3p-value: 0.1163Cochran-Mantel-Haenszel
Comparison: Day 7p-value: 0.044Cochran-Mantel-Haenszel