| 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 | 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). | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline and day 3 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-44.88± 19.75
- OG001-40.76± 18.91
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | ANCOVA | Terms for treatment, country (fixed), and the baseline pain VAS score | | | Mean Difference (Final Values) | 3.39 | Standard Error of the Mean | 2.11 | | 95 | -0.76 | 7.55 | | | Direction: nsNSAIDs minus celecoxib | | Non-Inferiority or Equivalence (legacy) | To conclude non inferiority, the lower bound of the 2-sided 95% confidence interval of the difference in change scores between the 2 treatment groups (nsNSAIDs - celecoxib) must be greater than -10 mm. |
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| 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 | 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). | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline and days 2, 3 and 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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 | 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). | Posted | | Number | | participants | | Days 2, 3 and 7 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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). | 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 | Posted | | Number | | participants | | Days 2, 3 and 7 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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) | 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 | Posted | | Number | | participants | | Days 3 and 7 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Pain Relief - MITT Population | Subject's response to the statement "My relief from starting pain is". Scale from 0 = None to 4 = Complete. | 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 | Posted | | Number | | participants | | Days 2, 3 and 7 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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) | 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 | Posted | | Number | | participants | | Days 2, 3 and 7 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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 | 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 | Posted | | Mean | Standard Deviation | scores on a scale | | Days 1, 3 and 7 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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 | 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 | Posted | | Mean | Standard Deviation | scores on a scale | | Days 2, 3 and 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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 | 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 | Posted | | Mean | Standard Deviation | scores on a scale | | Days 2, 3 and 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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 | 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 | Posted | | Mean | Standard Deviation | scores on a scale | | Days 2, 3 and 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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 | 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 | Posted | | Mean | Standard Deviation | scores on a scale | | Days 2, 3 and 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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 | 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 | Posted | | Mean | Standard Deviation | scores on a scale | | Days 2, 3 and 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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 | 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 | Posted | | Mean | Standard Deviation | scores on a scale | | Days 2, 3 and 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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 | 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 | Posted | | Mean | Standard Deviation | scores on a scale | | Days 2, 3 and 7 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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 | 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 | Posted | | Mean | Standard Deviation | scores on a scale | | Days 2, 3 and 7 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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 | 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 | Posted | | Mean | Standard Deviation | scores on a scale | | Days 2, 3 and 7 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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 | 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 | Posted | | Mean | Standard Deviation | scores on a scale | | Days 2, 3 and 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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 | 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 | Posted | | Mean | Standard Deviation | scores on a scale | | Days 2, 3 and 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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 | 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 | Posted | | Mean | Standard Deviation | scores on a scale | | Days 2, 3 and 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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