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Completed

NCT Number: NCT00446797

Open Label Comparative Study On Celecoxib Efficacy And Safety Vs 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.

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Key information

Conditions

Ankle Sprain Acute Pain Ankle Injuries Leg Injuries Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Goiânia, Goiás, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-selective NSAIDS

Drug

Non-selective NSAIDs administered at usual (standard) doses.

Celecoxib

Drug

celecoxib with an initial loading dose of 400 mg followed by 200 mg twice daily (BID) for up to 7 days.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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).

  4. 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)

  5. 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.

  6. 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)

  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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 13, 2007
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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