Open Label Comparative Study On Celecoxib Efficacy And Safety Vs Non-Selective NSAID In Acute Pain Due To Ankle Sprain

Study Overview
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Brief Summary
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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.

Official Title
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An Open Label Randomized Multicenter Comparative Study On Celecoxib Efficacy And Safety Versus Non-Selective NSAID In Acute Pain Due To Ankle Sprain

Conditions
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Ankle Sprain

Intervention / Treatment
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* Drug: Non-selective NSAIDS
* Drug: Celecoxib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-Selective NSAIDS<br>nsNSAIDs used in real-life standard practice for treatment of pain due to ankle sprain. | Drug: Non-selective NSAIDS<br>* Non-selective NSAIDs administered at usual (standard) doses.<br>|
| Experimental: Celecoxib<br> | Drug: Celecoxib<br>* celecoxib with an initial loading dose of 400 mg followed by 200 mg twice daily (BID) for up to 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline and day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline and days 2, 3 and 7 | 
| 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 | Days 2, 3 and 7 | 
| 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). | Days 2, 3 and 7 | 
| 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) | Days 3 and 7 | 
| Pain Relief - MITT Population | Subject's response to the statement My relief from starting pain is. Scale from 0 = None to 4 = Complete. | Days 2, 3 and 7 | 
| 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) | Days 2, 3 and 7 | 
| 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 | Days 1, 3 and 7 | 
| 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 | Days 2, 3 and 7 | 
| 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 | Days 2, 3 and 7 | 
| 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 | Days 2, 3 and 7 | 
| 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 | Days 2, 3 and 7 | 
| 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 | Days 2, 3 and 7 | 
| 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 | Days 2, 3 and 7 | 
| 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 | Days 2, 3 and 7 | 
| 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 | Days 2, 3 and 7 | 
| 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 | Days 2, 3 and 7 | 
| 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 | Days 2, 3 and 7 | 
| 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 | Days 2, 3 and 7 | 
| 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 | Days 2, 3 and 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ankle sprain, acute pain, NSAID, celecoxib,