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

Phase 4

Completed

Conditions: Ankle Sprain

Interventions: Drug: Non-selective NSAIDS
Drug: Celecoxib

Registration Number: NCT00446797

Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 278

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Selective NSAIDS	Non-selective NSAIDS	nsNSAIDs used in real-life standard practice for treatment of pain due to ankle sprain.
Celecoxib	Celecoxib	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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
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)
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 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
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
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 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 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 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 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