search
Back to results

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

Primary Purpose

Ankle Sprain

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Non-selective NSAIDS
Celecoxib
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprain focused on measuring Ankle sprain, acute pain, NSAID, celecoxib,

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Non-Selective NSAIDS

Celecoxib

Arm Description

nsNSAIDs used in real-life standard practice for treatment of pain due to ankle sprain.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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).
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)
Pain Relief - MITT Population
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Full Information

First Posted
March 9, 2007
Last Updated
February 18, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00446797
Brief Title
Open Label Comparative Study On Celecoxib Efficacy And Safety Vs Non-Selective NSAID In Acute Pain Due To Ankle Sprain
Official Title
An Open Label Randomized Multicenter Comparative Study On Celecoxib Efficacy And Safety Versus Non-Selective NSAID In Acute Pain Due To Ankle Sprain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprain
Keywords
Ankle sprain, acute pain, NSAID, celecoxib,

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
278 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-Selective NSAIDS
Arm Type
Active Comparator
Arm Description
nsNSAIDs used in real-life standard practice for treatment of pain due to ankle sprain.
Arm Title
Celecoxib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Non-selective NSAIDS
Intervention Description
Non-selective NSAIDs administered at usual (standard) doses.
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Description
celecoxib with an initial loading dose of 400 mg followed by 200 mg twice daily (BID) for up to 7 days.
Primary Outcome Measure Information:
Title
Change From Baseline at Day 3 in Pain Visual Analog Scale (VAS) - Per Protocol Population
Description
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
Secondary Outcome Measure Information:
Title
Change From Baseline in Pain Visual Analog Scale (VAS) - Modified Intent to Treat Population
Description
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
Title
Number of Subjects Responding (Improving) - MITT Population
Description
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
Title
Subject's Global Assessment of Ankle Injury
Description
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
Title
Physician Global Assessment of Ankle Injury
Description
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
Title
Pain Relief - MITT Population
Description
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
Title
Subject Assessment of Normal Function / Activity
Description
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
Title
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 1
Description
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
Title
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 2
Description
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
Title
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 3
Description
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
Title
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 4
Description
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
Title
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Index
Description
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
Title
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5A
Description
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
Title
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5B
Description
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
Title
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5C
Description
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
Title
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5D
Description
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
Title
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5E
Description
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
Title
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5F
Description
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
Title
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5G
Description
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
Title
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Index
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Goiânia
State/Province
GO
ZIP/Postal Code
74075-020
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20221-161
Country
Brazil
Facility Name
Pfizer Investigational Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
01221-900
Country
Brazil
Facility Name
Pfizer Investigational Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
02720-000
Country
Brazil
Facility Name
Pfizer Investigational Site
City
San Antonio Guadalupe
State/Province
Guadalupe, San Jose
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
Quito
State/Province
Pichincha
Country
Ecuador
Facility Name
Pfizer Investigational Site
City
Cairo
Country
Egypt
Facility Name
Pfizer Investigational Site
City
Amman
ZIP/Postal Code
11181 Jordan
Country
Jordan
Facility Name
Pfizer Investigational Site
City
Amman
ZIP/Postal Code
11193 Jordan
Country
Jordan
Facility Name
Pfizer Investigational Site
City
Amman
ZIP/Postal Code
22110 Jordan
Country
Jordan
Facility Name
Pfizer Investigational Site
City
Mexico
State/Province
DF
ZIP/Postal Code
10700
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Toluca
State/Province
Estado De México
ZIP/Postal Code
50180
Country
Mexico
Facility Name
Pfizer Investigational Site
City
San Nicolas de los Garza
State/Province
Nuevo León
ZIP/Postal Code
66451
Country
Mexico
Facility Name
Pfizer Investigational Site
City
México DF
ZIP/Postal Code
03020
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Panama City
Country
Panama
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
L27
Country
Peru

12. IPD Sharing Statement

Citations:
PubMed Identifier
32797734
Citation
Jones P, Lamdin R, Dalziel SR. Oral non-steroidal anti-inflammatory drugs versus other oral analgesic agents for acute soft tissue injury. Cochrane Database Syst Rev. 2020 Aug 12;8(8):CD007789. doi: 10.1002/14651858.CD007789.pub3.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3191332&StudyName=Open%20Label%20Comparative%20Study%20On%20Celecoxib%20Efficacy%20And%20Safety%20Vs%20Non-Selective%20NSAID%20In%20Acute%20Pain%20Due%20To%20Ankle%20Sprain
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs