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

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ClinicalTrials.gov Identifier: NCT00446797
Recruitment Status : Completed
First Posted : March 13, 2007
Results First Posted : June 10, 2009
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date  ICMJE March 9, 2007
First Posted Date  ICMJE March 13, 2007
Results First Submitted Date  ICMJE April 21, 2009
Results First Posted Date  ICMJE June 10, 2009
Last Update Posted Date February 21, 2021
Study Start Date  ICMJE May 2007
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2009)
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
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2007)
Change of patient's assessment of pain due to ankle sprain on the visual analog scale (VAS) from baseline to day 3.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2009)
  • 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
  • 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
  • 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).
  • 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)
  • 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.
  • 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)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2007)
  • Change from baseline in pain VAS score at 24 hours and Day 7
  • Patient's global assessment of ankle injury at 24 hours, Day 3 and Day 7
  • Physician's global assessment of ankle injury at Day 3 and Day 7
  • Responder rates (the proportion of patients improving by at least 20mm an the VAS scale at 24 hours,Day 3 and Day 7.
  • Proportion of patients with at least one grade improvement in pain relief (PR) at 24 hours, day 3 and day 7.
  • Patient's assessment of normal function/activity score at 24 hours, Day 3 and day 7.
  • Patient's responses to modified Brief Pain Inventory-Short Form (m.BPI-sf) individual items, pain severity composite, and pain interference composite scores, at 24 hours, Day 3 and Day 7.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Label Comparative Study On Celecoxib Efficacy And Safety Vs Non-Selective NSAID In Acute Pain Due To Ankle Sprain
Official Title  ICMJE An Open Label Randomized Multicenter Comparative Study On Celecoxib Efficacy And Safety Versus Non-Selective NSAID In Acute Pain Due To Ankle Sprain
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ankle Sprain
Intervention  ICMJE
  • Drug: Non-selective NSAIDS
    Non-selective NSAIDs administered at usual (standard) doses.
  • Drug: Celecoxib
    celecoxib with an initial loading dose of 400 mg followed by 200 mg twice daily (BID) for up to 7 days.
Study Arms  ICMJE
  • Active Comparator: Non-Selective NSAIDS
    nsNSAIDs used in real-life standard practice for treatment of pain due to ankle sprain.
    Intervention: Drug: Non-selective NSAIDS
  • Experimental: Celecoxib
    Intervention: Drug: Celecoxib
Publications * 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:CD007789. doi: 10.1002/14651858.CD007789.pub3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 21, 2009)
278
Original Enrollment  ICMJE
 (submitted: March 9, 2007)
222
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Costa Rica,   Ecuador,   Egypt,   Jordan,   Mexico,   Panama,   Peru
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00446797
Other Study ID Numbers  ICMJE A3191332
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP