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

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

278

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • GO
      • Goiânia, GO, Brazil, 74075-020
        • Pfizer Investigational Site
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20221-161
        • Pfizer Investigational Site
    • SP
      • São Paulo, SP, Brazil, 01221-900
        • Pfizer Investigational Site
      • São Paulo, SP, Brazil, 02720-000
        • Pfizer Investigational Site
    • Guadalupe, San Jose
      • San Antonio Guadalupe, Guadalupe, San Jose, Costa Rica
        • Pfizer Investigational Site
    • Pichincha
      • Quito, Pichincha, Ecuador
        • Pfizer Investigational Site
      • Cairo, Egypt
        • Pfizer Investigational Site
      • Amman, Jordan, 11181 Jordan
        • Pfizer Investigational Site
      • Amman, Jordan, 11193 Jordan
        • Pfizer Investigational Site
      • Amman, Jordan, 22110 Jordan
        • Pfizer Investigational Site
      • México DF, Mexico, 03020
        • Pfizer Investigational Site
    • DF
      • Mexico, DF, Mexico, 10700
        • Pfizer Investigational Site
    • Estado De México
      • Toluca, Estado De México, Mexico, 50180
        • Pfizer Investigational Site
    • Nuevo León
      • San Nicolas de los Garza, Nuevo León, Mexico, 66451
        • Pfizer Investigational Site
      • Panama City, Panama
        • Pfizer Investigational Site
      • Lima, Peru, L27
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline at Day 3 in Pain Visual Analog Scale (VAS) - Per Protocol Population
Time Frame: 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
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
Time Frame: 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
Baseline and days 2, 3 and 7
Number of Subjects Responding (Improving) - MITT Population
Time Frame: 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
Days 2, 3 and 7
Subject's Global Assessment of Ankle Injury
Time Frame: 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).
Days 2, 3 and 7
Physician Global Assessment of Ankle Injury
Time Frame: 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)
Days 3 and 7
Pain Relief - MITT Population
Time Frame: Days 2, 3 and 7
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
Time Frame: 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)
Days 2, 3 and 7
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 1
Time Frame: 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

Days 1, 3 and 7
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 2
Time Frame: 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

Days 2, 3 and 7
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 3
Time Frame: 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

Days 2, 3 and 7
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 4
Time Frame: 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

Days 2, 3 and 7
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Index
Time Frame: 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

Days 2, 3 and 7
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5A
Time Frame: 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

Days 2, 3 and 7
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5B
Time Frame: 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

Days 2, 3 and 7
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5C
Time Frame: 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

Days 2, 3 and 7
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5D
Time Frame: 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

Days 2, 3 and 7
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5E
Time Frame: 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

Days 2, 3 and 7
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5F
Time Frame: 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

Days 2, 3 and 7
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5G
Time Frame: 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

Days 2, 3 and 7
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Index
Time Frame: 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

Days 2, 3 and 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

March 9, 2007

First Submitted That Met QC Criteria

March 9, 2007

First Posted (Estimate)

March 13, 2007

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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