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CompletedNCT00446797Updated Feb 21, 2021Results posted

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

A Phase 4 interventional study of Non-selective NSAIDS and Celecoxib in Ankle Sprain, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 16 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-21.

Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
278
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Ankle Sprain

Keywords

  • Ankle sprain, acute pain, NSAID, celecoxib,
03

In context

Acute Pain

876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.

This study's enrollment of 278 is above the median of 90 across 732 interventional studies indexed under Acute Pain.

Browse Acute Pain studies →

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
278 participants (actual)

Study arms

  • Active comparator
    Non-Selective NSAIDS

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

    Drug: Non-selective NSAIDS

  • Experimental
    Celecoxib

    Drug: Celecoxib

Interventions

  • DrugNon-selective NSAIDS

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

  • DrugCelecoxib

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline and day 3

Secondary outcomes

  1. 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

    Time frame: Baseline and days 2, 3 and 7

  2. 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

    Time frame: Days 2, 3 and 7

  3. 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).

    Time frame: Days 2, 3 and 7

  4. 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)

    Time frame: Days 3 and 7

  5. Pain Relief - MITT Population

    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

  6. 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)

    Time frame: Days 2, 3 and 7

  7. 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

    Time frame: Days 1, 3 and 7

  8. 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

    Time frame: Days 2, 3 and 7

  9. 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

    Time frame: Days 2, 3 and 7

  10. 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

    Time frame: Days 2, 3 and 7

  11. 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

    Time frame: Days 2, 3 and 7

  12. 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

    Time frame: Days 2, 3 and 7

  13. 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

    Time frame: Days 2, 3 and 7

  14. 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

    Time frame: Days 2, 3 and 7

  15. 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

    Time frame: Days 2, 3 and 7

  16. 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

    Time frame: Days 2, 3 and 7

  17. 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

    Time frame: Days 2, 3 and 7

  18. 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

    Time frame: Days 2, 3 and 7

  19. 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

    Time frame: Days 2, 3 and 7

07

Results

Posted Jun 10, 2009

Participant flow

Locations used were emergency rooms at orthopedic hospitals, general hospitals or private doctor's offices

Participant flow — Overall Study
MilestoneCelecoxibnsNSAIDs
Started141137
Completed133125
Not completed812
Withdrew: Lack of efficacy02
Withdrew: Lost to follow-up53
Withdrew: Withdrawal by subject22
Withdrew: Protocol violation13
Withdrew: Subject entered at another site01
Withdrew: Did not meet entrance criteria01

Outcome measures

PrimaryChange 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

Time frame:
Baseline and day 3
Reported as:
Mean · scores on a scale
Change From Baseline at Day 3 in Pain Visual Analog Scale (VAS) - Per Protocol Population
scores on a scaleCelecoxibnsNSAIDs
Change From Baseline at Day 3 in Pain Visual Analog Scale (VAS) - Per Protocol Population-44.88 ± 19.75-40.76 ± 18.91
Statistical analysis
  • Celecoxib vs nsNSAIDs · ANCOVA · Mean difference (final values): 3.39 · 95% CI -0.76 to 7.55Direction: nsNSAIDs minus celecoxib
SecondaryChange 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

Time frame:
Baseline and days 2, 3 and 7
Reported as:
Mean · scores on a scale
Change From Baseline in Pain Visual Analog Scale (VAS) - Modified Intent to Treat Population
scores on a scaleCelecoxibnsNSAIDs
Day 2-29.25 ± 18.99-25.98 ± 18.21
Day 3-44.87 ± 19.51-40.75 ± 18.74
Day 7-61.17 ± 18.43-57.89 ± 18.84
Statistical analysis
  • Celecoxib vs nsNSAIDs · ANCOVA · Mean difference (final values): 3.10 · 95% CI -0.89 to 7.08Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · Mean difference (final values): 3.46 · 95% CI -0.55 to 7.48Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · Mean difference (final values): 2.76 · 95% CI -0.91 to 6.42Direction: nsNSAIDs minus celecoxib
SecondaryNumber 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

Time frame:
Days 2, 3 and 7
Reported as:
Number · participants
Number of Subjects Responding (Improving) - MITT Population
participantsCelecoxibnsNSAIDs
Day 2 - response (N=134, 133)9179
Day 2 - no response4354
Day 3 - response (N=135, 131)124116
Day 3 - no response1115
Day 7 - response (N=133, 125)129120
Day 7 - no response45
Statistical analysis
  • Celecoxib vs nsNSAIDs · Regression, Logistic · p = 0.1591 (Threshold for statistical significance: p value is less than or equal to 0.05)Terms for treatment and the baseline pain VAS score
  • Celecoxib vs nsNSAIDs · Regression, Logistic · p = 0.3995 (Threshold for statistical significance: p value is less than or equal to 0.05)Terms for treatment and the baseline pain VAS score
  • Celecoxib vs nsNSAIDs · Regression, Logistic · p = 0.6805 (Threshold for statistical significance: p value is less than or equal to 0.05)Terms for treatment and the baseline pain VAS score
SecondarySubject'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).

Time frame:
Days 2, 3 and 7
Reported as:
Number · participants
Subject's Global Assessment of Ankle Injury
participantsCelecoxibnsNSAIDs
Day 2 - Very good (no symptoms) (N=135, 133)11
Day 2 - Good (mild symptoms)4031
Day 2 - Fair (moderate symptoms)7680
Day 2 - Poor (severe symptoms)1719
Day 2- Very poor (very severe symptoms)12
Day 3 - Very good (no symptoms) (N=135, 131)86
Day 3 - Good (mild symptoms)6855
Day 3 - Fair (moderate symptoms)5463
Day 3 - Poor (severe symptoms)57
Day 3 - Very poor (very severe symptoms)00
Day 7 - Very good (no symptoms) (N=133, 125)5337
Day 7 - Good (mild symptoms)6163
Day 7 - Fair (moderate symptoms)1721
Day 7 - Poor (severe symptoms)24
Day 7 - Very poor (very severe symptoms)00
Statistical analysis
  • Celecoxib vs nsNSAIDs · Cochran-Mantel-Haenszel · p = 0.2411 (Threshold for statistical significance: p value is less than or equal to 0.05)Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)
  • Celecoxib vs nsNSAIDs · Cochran-Mantel-Haenszel · p = 0.1163 (Threshold for statistical significance: p value is less than or equal to 0.05)Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)
  • Celecoxib vs nsNSAIDs · Cochran-Mantel-Haenszel · p = 0.0440 (Threshold for statistical significance: p value is less than or equal to 0.05)Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)
SecondaryPhysician 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)

Time frame:
Days 3 and 7
Reported as:
Number · participants
Physician Global Assessment of Ankle Injury
participantsCelecoxibnsNSAIDs
Day 3 - very mild (N=134, 131)2012
Day 3 - mild7179
Day 3 - moderate4038
Day 3 - severe22
Day 3 - very severe10
Day 7 - very mild (N=132, 125)8770
Day 7 - mild3847
Day 7 - moderate77
Day 7 - severe01
Day 7 - very severe00
Statistical analysis
  • Celecoxib vs nsNSAIDs · Cochran-Mantel-Haenszel · p = 0.7223 (Threshold for statistical significance: p value is less than or equal to 0.05)Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)
  • Celecoxib vs nsNSAIDs · Cochran-Mantel-Haenszel · p = 0.0541 (Threshold for statistical significance: p value is less than or equal to 0.05)Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)
SecondaryPain Relief - MITT Population

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
Reported as:
Number · participants
Pain Relief - MITT Population
participantsCelecoxibnsNSAIDs
Day 2 - None (N=135, 132)85
Day 2 - A little2533
Day 2 - Some4952
Day 2 - A lot5242
Day 2 -Complete10
Day 3 - None (N=135, 131)01
Day 3 - A little1521
Day 3 - Some3346
Day 3 - A lot8460
Day 3 -Complete33
Day 7 - None (N=133, 125)11
Day 7 - A little63
Day 7 - Some715
Day 7 - A lot7780
Day 7 -Complete4226
Statistical analysis
  • Celecoxib vs nsNSAIDs · Cochran-Mantel-Haenszel · p = 0.2900 (Threshold for statistical significance: p value is less than or equal to 0.05)Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)
  • Celecoxib vs nsNSAIDs · Cochran-Mantel-Haenszel · p = 0.0157 (Threshold for statistical significance: p value is less than or equal to 0.05)Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)
  • Celecoxib vs nsNSAIDs · Cochran-Mantel-Haenszel · p = 0.1206 (Threshold for statistical significance: p value is less than or equal to 0.05)Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)
SecondarySubject 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)

Time frame:
Days 2, 3 and 7
Reported as:
Number · participants
Subject Assessment of Normal Function / Activity
participantsCelecoxibnsNSAIDs
Day 2 - normal no pain (N =135, 133)52
Day 2 - normal with pain4030
Day 2 - mildly restricted5955
Day 2 - moderately restricted1939
Day 2 - severely restricted127
Day 3 - normal no pain (N = 135, 131)1813
Day 3 - normal with pain5246
Day 3 - mildly restricted4957
Day 3 - moderately restricted1411
Day 3 - severely restricted24
Day 7 - normal no pain (N = 133, 125)6243
Day 7 - normal with pain5568
Day 7 - mildly restricted118
Day 7 - moderately restricted43
Day 7 - severely restricted13
Statistical analysis
  • Celecoxib vs nsNSAIDs · Cochran-Mantel-Haenszel · p = 0.0846 (Threshold for statistical significance: p value is less than or equal to 0.05)Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)
  • Celecoxib vs nsNSAIDs · Cochran-Mantel-Haenszel · p = 0.3041 (Threshold for statistical significance: p value is less than or equal to 0.05)Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)
  • Celecoxib vs nsNSAIDs · Cochran-Mantel-Haenszel · p = 0.1216 (Threshold for statistical significance: p value is less than or equal to 0.05)Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)
SecondaryModified 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

Time frame:
Days 1, 3 and 7
Reported as:
Mean · scores on a scale
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 1
scores on a scaleCelecoxibnsNSAIDs
Day 2 (N = 134, 133)5.71 ± 2.045.90 ± 2.06
Day 3 (N = 135, 131)3.81 ± 1.844.44 ± 1.91
Day 7 (N = 133, 125)2.08 ± 1.932.38 ± 1.78
Statistical analysis
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.395 (Overall p-value) · Mean difference (final values): 0.14 · 95% CI -0.33 to 0.62Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.004 (Overall p value) · Mean difference (final values): 0.61 · 95% CI 0.18 to 1.04Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.122 (Overall p value) · Mean difference (final values): 0.35 · 95% CI -0.08 to 0.77Direction: nsNSAIDs minus celecoxib
SecondaryModified 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

Time frame:
Days 2, 3 and 7
Reported as:
Mean · scores on a scale
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 2
scores on a scaleCelecoxibnsNSAIDs
Day 2 (N = 133, 133)3.25 ± 1.833.36 ± 1.88
Day 3 (N = 135, 131)2.07 ± 1.682.40 ± 1.64
Day 7 (N = 133, 125)0.83 ± 1.261.16 ± 1.43
Statistical analysis
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.604 (Overall p value) · Mean difference (final values): 0.09 · 95% CI -0.32 to 0.49Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.124 (Overall p value) · Mean difference (final values): 0.28 · 95% CI -0.07 to 0.63Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.062 (Overall p value) · Mean difference (final values): 0.32 · 95% CI 0.03 to 0.61Direction: nsNSAIDs minus celecoxib
SecondaryModified 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

Time frame:
Days 2, 3 and 7
Reported as:
Mean · scores on a scale
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 3
scores on a scaleCelecoxibnsNSAIDs
Day 2 (N = 134, 133)4.34 ± 1.794.41 ± 1.90
Day 3 (N = 135, 131)2.90 ± 1.703.26 ± 1.63
Day 7 (N = 133, 125)1.41 ± 1.561.74 ± 1.53
Statistical analysis
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.705 (Overall p value) · Mean difference (final values): 0.05 · 95% CI -0.36 to 0.47Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.064 (Overall p value) · Mean difference (final values): 0.36 · 95% CI -0.01 to 0.73Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.074 (Overall p value) · Mean difference (final values): 0.34 · 95% CI -0.01 to 0.68Direction: nsNSAIDs minus celecoxib
SecondaryModified 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

Time frame:
Days 2, 3 and 7
Reported as:
Mean · scores on a scale
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 4
scores on a scaleCelecoxibnsNSAIDs
Day 2 (N = 134, 133)3.64 ± 2.054.23 ± 2.26
Day 3 (N =135, 131)2.58 ± 1.812.92 ± 1.78
Day 7 (N = 133, 125)1.14 ± 1.561.43 ± 1.55
Statistical analysis
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.017 (Overall p value) · Mean difference (final values): 0.58 · 95% CI 0.11 to 1.05Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.108 (Overall p value) · Mean difference (final values): 0.34 · 95% CI -0.05 to 0.74Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.117 (Overall p value) · Mean difference (final values): 0.32 · 95% CI -0.01 to 0.66Direction: nsNSAIDs minus celecoxib
SecondaryModified 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

Time frame:
Days 2, 3 and 7
Reported as:
Mean · scores on a scale
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Index
scores on a scaleCelecoxibnsNSAIDs
Day 2 (N = 134, 133)4.24 ± 1.664.48 ± 1.84
Day 3 (N = 135, 131)2.84 ± 1.613.26 ± 1.57
Day 7 (N = 133, 125)1.37 ± 1.471.68 ± 1.44
Statistical analysis
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.229 (Overall p value) · Mean difference (final values): 0.21 · 95% CI -0.17 to 0.60Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.027 (Overall p value) · Mean difference (final values): 0.40 · 95% CI 0.05 to 0.75Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.070 (Overall p value) · Mean difference (final values): 0.33 · 95% CI 0.01 to 0.65Direction: nsNSAIDs minus celecoxib
SecondaryModified 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

Time frame:
Days 2, 3 and 7
Reported as:
Mean · scores on a scale
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5A
scores on a scaleCelecoxibnsNSAIDs
Day 2 (N = 134, 133)5.40 ± 2.525.37 ± 2.62
Day 3 (N = 135, 131)3.65 ± 2.644.07 ± 2.60
Day 7 (N = 133, 125)1.78 ± 2.131.90 ± 1.94
Statistical analysis
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.954 (Overall p value) · Mean difference (final values): -0.05 · 95% CI -0.64 to 0.53Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.172 (Overall p value) · Mean difference (final values): 0.41 · 95% CI -0.19 to 1.02Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.541 (Overall p value) · Mean difference (final values): 0.16 · 95% CI -0.30 to 0.62Direction: nsNSAIDs minus celecoxib
SecondaryModified 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

Time frame:
Days 2, 3 and 7
Reported as:
Mean · scores on a scale
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5B
scores on a scaleCelecoxibnsNSAIDs
Day 2 (N = 134, 133)3.72 ± 2.953.64 ± 2.87
Day 3 (N = 135, 131)2.43 ± 2.412.38 ± 2.60
Day 7 (N = 133, 125)1.17 ± 2.061.26 ± 2.01
Statistical analysis
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.924 (Overall p value) · Mean difference (final values): -0.08 · 95% CI -0.75 to 0.58Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.898 (Overall p value) · Mean difference (final values): -0.06 · 95% CI -0.62 to 0.51Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.655 (Overall p value) · Mean difference (final values): 0.13 · 95% CI -0.33 to 0.60Direction: nsNSAIDs minus celecoxib
SecondaryModified 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

Time frame:
Days 2, 3 and 7
Reported as:
Mean · scores on a scale
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5C
scores on a scaleCelecoxibnsNSAIDs
Day 2 (N = 134, 133)5.10 ± 2.765.11 ± 2.74
Day 3 (N = 135, 131)3.58 ± 2.623.69 ± 2.67
Day 7 (N = 133, 125)1.65 ± 2.191.62 ± 1.93
Statistical analysis
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.929 (Overall p value) · Mean difference (final values): 0.02 · 95% CI -0.59 to 0.62Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.712 (Overall p value) · Mean difference (final values): 0.11 · 95% CI -0.50 to 0.71Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.993 (Overall p value) · Mean difference (final values): 0.04 · 95% CI -0.44 to 0.51Direction: nsNSAIDs minus celecoxib
SecondaryModified 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

Time frame:
Days 2, 3 and 7
Reported as:
Mean · scores on a scale
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5D
scores on a scaleCelecoxibnsNSAIDs
Day 2 (N = 134, 133)5.29 ± 2.955.39 ± 2.76
Day 3 (N = 135, 131)4.04 ± 2.924.04 ± 2.88
Day 7 (N = 133, 125)1.84 ± 2.421.87 ± 2.11
Statistical analysis
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.779 (Overall p value) · Mean difference (final values): 0.11 · 95% CI -0.53 to 0.75Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.972 (Overall p value) · Mean difference (final values): -0.02 · 95% CI -0.69 to 0.65Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.844 (Overall p value) · Mean difference (final values): 0.07 · 95% CI -0.47 to 0.61Direction: nsNSAIDs minus celecoxib
SecondaryModified 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

Time frame:
Days 2, 3 and 7
Reported as:
Mean · scores on a scale
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5E
scores on a scaleCelecoxibnsNSAIDs
Day 2 (N = 134, 133)2.70 ± 2.782.67 ± 2.68
Day 3 (N = 135, 131)1.81 ± 2.261.69 ± 2.26
Day 7 (N = 133, 125)0.80 ± 1.700.78 ± 1.48
Statistical analysis
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.944 (Overall p value) · Mean difference (final values): -0.02 · 95% CI -0.63 to 0.60Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.654 (Overall p value) · Mean difference (final values): -0.12 · 95% CI -0.62 to 0.38Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.952 (Overall p value) · Mean difference (final values): 0.01 · 95% CI -0.36 to 0.39Direction: nsNSAIDs minus celecoxib
SecondaryModified 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

Time frame:
Days 2, 3 and 7
Reported as:
Mean · scores on a scale
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5F
scores on a scaleCelecoxibnsNSAIDs
Day 2 (N = 134, 133)2.97 ± 2.882.87 ± 2.64
Day 3 (N = 135, 131)1.90 ± 2.401.86 ± 2.28
Day 7 (N = 133, 125)0.68 ± 1.770.82 ± 1.61
Statistical analysis
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.842 (Overall p value) · Mean difference (final values): -0.03 · 95% CI -0.65 to 0.59Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.828 (Overall p value) · Mean difference (final values): -0.04 · 95% CI -0.57 to 0.49Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.542 (Overall p value) · Mean difference (final values): 0.12 · 95% CI -0.30 to 0.53Direction: nsNSAIDs minus celecoxib
SecondaryModified 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

Time frame:
Days 2, 3 and 7
Reported as:
Mean · scores on a scale
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5G
scores on a scaleCelecoxibnsNSAIDs
Day 2 (N = 134, 133)3.33 ± 3.172.99 ± 2.81
Day 3 (N = 135, 131)2.13 ± 2.692.06 ± 2.48
Day 7 (N = 133, 125)1.07 ± 1.981.10 ± 1.80
Statistical analysis
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.404 (Overall p value) · Mean difference (final values): -0.25 · 95% CI -0.92 to 0.42Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.816 (Overall p value) · Mean difference (final values): 0.02 · 95% CI -0.53 to 0.58Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.837 (Overall p value) · Mean difference (final values): 0.07 · 95% CI -0.37 to 0.52Direction: nsNSAIDs minus celecoxib
SecondaryModified 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

Time frame:
Days 2, 3 and 7
Reported as:
Mean · scores on a scale
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Index
scores on a scaleCelecoxibnsNSAIDs
Day 2 (N = 134, 133)4.07 ± 2.344.01 ± 2.12
Day 3 (N = 135, 131)2.79 ± 2.152.83 ± 2.07
Day 7 (N = 133, 125)1.28 ± 1.811.33 ± 1.54
Statistical analysis
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.887 (Overall p value) · Mean difference (final values): -0.04 · 95% CI -0.54 to 0.45Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.889 (Overall p value) · Mean difference (final values): 0.04 · 95% CI -0.43 to 0.51Direction: nsNSAIDs minus celecoxib
  • Celecoxib vs nsNSAIDs · ANCOVA · p = 0.738 (Overall p value) · Mean difference (final values): 0.09 · 95% CI -0.30 to 0.47Direction: nsNSAIDs minus celecoxib

Adverse events

Non-serious events are listed at a 1.5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Celecoxib———
nsNSAIDs———
Most frequent serious events
Most frequent serious events
EventCelecoxibnsNSAIDs
Dengue feverInfections and infestations0/1411/137
Tendon ruptureInjury, poisoning and procedural complications0/1411/137
Most frequent other events
Most frequent other events
EventCelecoxibnsNSAIDs
GastritisGastrointestinal disorders2/1415/137
SomnolenceNervous system disorders5/1412/137
HyperchlorhydriaGastrointestinal disorders1/1413/137
HeadacheNervous system disorders3/1410/137
Abdominal pain upperGastrointestinal disorders0/1412/137
DiarrhoeaGastrointestinal disorders1/1412/137
DyspepsiaGastrointestinal disorders1/1412/137
NauseaGastrointestinal disorders1/1412/137

Baseline characteristics

Age, Continuous
Age, Continuous(years)CelecoxibnsNSAIDsTotal
Mean30.6 (18 to 66)30.4 (18 to 74)30.5 (18 to 74)
Sex: Female, Male
Sex: Female, Male(Participants)CelecoxibnsNSAIDsTotal
Female5655111
Male8582167
08

Study locations

16 sites
  • Pfizer Investigational Site
    Goiânia, GO 74075-020, Brazil
  • Pfizer Investigational Site
    Rio de Janeiro, RJ 20221-161, Brazil
  • Pfizer Investigational Site
    São Paulo, SP 01221-900, Brazil
  • Pfizer Investigational Site
    São Paulo, SP 02720-000, Brazil
  • Pfizer Investigational Site
    San Antonio Guadalupe, Guadalupe, San Jose, Costa Rica
  • Pfizer Investigational Site
    Quito, Pichincha, Ecuador
  • Pfizer Investigational Site
    Cairo, Egypt
  • Pfizer Investigational Site
    Amman, 11181 Jordan, Jordan
  • Pfizer Investigational Site
    Amman, 11193 Jordan, Jordan
  • Pfizer Investigational Site
    Amman, 22110 Jordan, Jordan
  • Pfizer Investigational Site
    Mexico, DF 10700, Mexico
  • Pfizer Investigational Site
    Toluca, Estado De México 50180, Mexico
  • Pfizer Investigational Site
    San Nicolas de los Garza, Nuevo León 66451, Mexico
  • Pfizer Investigational Site
    México DF, 03020, Mexico
  • Pfizer Investigational Site
    Panama City, Panama
  • Pfizer Investigational Site
    Lima, L27, Peru
09

References and documents

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(8):CD007789. doi: 10.1002/14651858.CD007789.pub3. PubMed 32797734 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00446797
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Responsible party
Sponsor
First posted
Mar 13, 2007
Start date
May 2007
Primary completion
Apr 2008
Completion
Apr 2008
Results posted
Jun 10, 2009
Last update
Feb 21, 2021

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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