Trial Outcomes & Findings for Open Label Comparative Study On Celecoxib Efficacy And Safety Vs Non-Selective NSAID In Acute Pain Due To Ankle Sprain (NCT NCT00446797)
NCT ID: NCT00446797
Last Updated: 2021-02-21
Results Overview
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
COMPLETED
PHASE4
278 participants
Baseline and day 3
2021-02-21
Participant Flow
Locations used were emergency rooms at orthopedic hospitals, general hospitals or private doctor's offices
Subjects sustained ankle sprain with a pain rating of greater than or equal to 45mm on a visual analog scale on full weight bearing, no more than 48 hours prior to the first dose of study medication
Participant milestones
| Measure |
Celecoxib
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
|
nsNSAIDs
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
|
|---|---|---|
|
Overall Study
STARTED
|
141
|
137
|
|
Overall Study
COMPLETED
|
133
|
125
|
|
Overall Study
NOT COMPLETED
|
8
|
12
|
Reasons for withdrawal
| Measure |
Celecoxib
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
|
nsNSAIDs
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Protocol Violation
|
1
|
3
|
|
Overall Study
subject entered at another site
|
0
|
1
|
|
Overall Study
did not meet entrance criteria
|
0
|
1
|
Baseline Characteristics
Open Label Comparative Study On Celecoxib Efficacy And Safety Vs Non-Selective NSAID In Acute Pain Due To Ankle Sprain
Baseline characteristics by cohort
| Measure |
Celecoxib
n=141 Participants
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
|
nsNSAIDs
n=137 Participants
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
|
Total
n=278 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.6 years
n=5 Participants
|
30.4 years
n=7 Participants
|
30.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and day 3Population: Per protocol (PP) population included subjects who were randomized, received full loading dose of study medication on day 1 and took no prohibited medications up to and including day 3, had valid baseline and day 3 VAS scores and had no major protocol violations before or during the study (i.e. a subset of treated subjects).
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
Outcome measures
| Measure |
Celecoxib
n=131 Participants
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
|
nsNSAIDs
n=126 Participants
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
|
|---|---|---|
|
Change From Baseline at Day 3 in Pain Visual Analog Scale (VAS) - Per Protocol Population
|
-44.88 scores on a scale
Standard Deviation 19.75
|
-40.76 scores on a scale
Standard Deviation 18.91
|
SECONDARY outcome
Timeframe: Baseline and days 2, 3 and 7Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment (i.e. a subset of treated subjects).
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
Outcome measures
| Measure |
Celecoxib
n=135 Participants
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
|
nsNSAIDs
n=133 Participants
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
|
|---|---|---|
|
Change From Baseline in Pain Visual Analog Scale (VAS) - Modified Intent to Treat Population
Day 2
|
-29.25 scores on a scale
Standard Deviation 18.99
|
-25.98 scores on a scale
Standard Deviation 18.21
|
|
Change From Baseline in Pain Visual Analog Scale (VAS) - Modified Intent to Treat Population
Day 3
|
-44.87 scores on a scale
Standard Deviation 19.51
|
-40.75 scores on a scale
Standard Deviation 18.74
|
|
Change From Baseline in Pain Visual Analog Scale (VAS) - Modified Intent to Treat Population
Day 7
|
-61.17 scores on a scale
Standard Deviation 18.43
|
-57.89 scores on a scale
Standard Deviation 18.84
|
SECONDARY outcome
Timeframe: Days 2, 3 and 7Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment (i.e. a subset of treated subjects).
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
Outcome measures
| Measure |
Celecoxib
n=135 Participants
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
|
nsNSAIDs
n=133 Participants
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
|
|---|---|---|
|
Number of Subjects Responding (Improving) - MITT Population
Day 2 - response (N=134, 133)
|
91 participants
|
79 participants
|
|
Number of Subjects Responding (Improving) - MITT Population
Day 2 - no response
|
43 participants
|
54 participants
|
|
Number of Subjects Responding (Improving) - MITT Population
Day 3 - response (N=135, 131)
|
124 participants
|
116 participants
|
|
Number of Subjects Responding (Improving) - MITT Population
Day 3 - no response
|
11 participants
|
15 participants
|
|
Number of Subjects Responding (Improving) - MITT Population
Day 7 - response (N=133, 125)
|
129 participants
|
120 participants
|
|
Number of Subjects Responding (Improving) - MITT Population
Day 7 - no response
|
4 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Days 2, 3 and 7Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
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).
Outcome measures
| Measure |
Celecoxib
n=135 Participants
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
|
nsNSAIDs
n=133 Participants
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
|
|---|---|---|
|
Subject's Global Assessment of Ankle Injury
Day 2 - Very good (no symptoms) (N=135, 133)
|
1 participants
|
1 participants
|
|
Subject's Global Assessment of Ankle Injury
Day 2 - Good (mild symptoms)
|
40 participants
|
31 participants
|
|
Subject's Global Assessment of Ankle Injury
Day 2 - Fair (moderate symptoms)
|
76 participants
|
80 participants
|
|
Subject's Global Assessment of Ankle Injury
Day 2 - Poor (severe symptoms)
|
17 participants
|
19 participants
|
|
Subject's Global Assessment of Ankle Injury
Day 2- Very poor (very severe symptoms)
|
1 participants
|
2 participants
|
|
Subject's Global Assessment of Ankle Injury
Day 3 - Very good (no symptoms) (N=135, 131)
|
8 participants
|
6 participants
|
|
Subject's Global Assessment of Ankle Injury
Day 3 - Good (mild symptoms)
|
68 participants
|
55 participants
|
|
Subject's Global Assessment of Ankle Injury
Day 3 - Fair (moderate symptoms)
|
54 participants
|
63 participants
|
|
Subject's Global Assessment of Ankle Injury
Day 3 - Poor (severe symptoms)
|
5 participants
|
7 participants
|
|
Subject's Global Assessment of Ankle Injury
Day 3 - Very poor (very severe symptoms)
|
0 participants
|
0 participants
|
|
Subject's Global Assessment of Ankle Injury
Day 7 - Very good (no symptoms) (N=133, 125)
|
53 participants
|
37 participants
|
|
Subject's Global Assessment of Ankle Injury
Day 7 - Good (mild symptoms)
|
61 participants
|
63 participants
|
|
Subject's Global Assessment of Ankle Injury
Day 7 - Fair (moderate symptoms)
|
17 participants
|
21 participants
|
|
Subject's Global Assessment of Ankle Injury
Day 7 - Poor (severe symptoms)
|
2 participants
|
4 participants
|
|
Subject's Global Assessment of Ankle Injury
Day 7 - Very poor (very severe symptoms)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 3 and 7Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
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)
Outcome measures
| Measure |
Celecoxib
n=135 Participants
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
|
nsNSAIDs
n=133 Participants
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
|
|---|---|---|
|
Physician Global Assessment of Ankle Injury
Day 3 - very mild (N=134, 131)
|
20 participants
|
12 participants
|
|
Physician Global Assessment of Ankle Injury
Day 3 - mild
|
71 participants
|
79 participants
|
|
Physician Global Assessment of Ankle Injury
Day 3 - moderate
|
40 participants
|
38 participants
|
|
Physician Global Assessment of Ankle Injury
Day 3 - severe
|
2 participants
|
2 participants
|
|
Physician Global Assessment of Ankle Injury
Day 3 - very severe
|
1 participants
|
0 participants
|
|
Physician Global Assessment of Ankle Injury
Day 7 - very mild (N=132, 125)
|
87 participants
|
70 participants
|
|
Physician Global Assessment of Ankle Injury
Day 7 - mild
|
38 participants
|
47 participants
|
|
Physician Global Assessment of Ankle Injury
Day 7 - moderate
|
7 participants
|
7 participants
|
|
Physician Global Assessment of Ankle Injury
Day 7 - severe
|
0 participants
|
1 participants
|
|
Physician Global Assessment of Ankle Injury
Day 7 - very severe
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 2, 3 and 7Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
Subject's response to the statement "My relief from starting pain is". Scale from 0 = None to 4 = Complete.
Outcome measures
| Measure |
Celecoxib
n=135 Participants
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
|
nsNSAIDs
n=133 Participants
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
|
|---|---|---|
|
Pain Relief - MITT Population
Day 2 - None (N=135, 132)
|
8 participants
|
5 participants
|
|
Pain Relief - MITT Population
Day 2 - A little
|
25 participants
|
33 participants
|
|
Pain Relief - MITT Population
Day 2 - Some
|
49 participants
|
52 participants
|
|
Pain Relief - MITT Population
Day 2 - A lot
|
52 participants
|
42 participants
|
|
Pain Relief - MITT Population
Day 2 -Complete
|
1 participants
|
0 participants
|
|
Pain Relief - MITT Population
Day 3 - None (N=135, 131)
|
0 participants
|
1 participants
|
|
Pain Relief - MITT Population
Day 3 - A little
|
15 participants
|
21 participants
|
|
Pain Relief - MITT Population
Day 3 - Some
|
33 participants
|
46 participants
|
|
Pain Relief - MITT Population
Day 3 - A lot
|
84 participants
|
60 participants
|
|
Pain Relief - MITT Population
Day 3 -Complete
|
3 participants
|
3 participants
|
|
Pain Relief - MITT Population
Day 7 - None (N=133, 125)
|
1 participants
|
1 participants
|
|
Pain Relief - MITT Population
Day 7 - A little
|
6 participants
|
3 participants
|
|
Pain Relief - MITT Population
Day 7 - Some
|
7 participants
|
15 participants
|
|
Pain Relief - MITT Population
Day 7 - A lot
|
77 participants
|
80 participants
|
|
Pain Relief - MITT Population
Day 7 -Complete
|
42 participants
|
26 participants
|
SECONDARY outcome
Timeframe: Days 2, 3 and 7Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
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)
Outcome measures
| Measure |
Celecoxib
n=135 Participants
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
|
nsNSAIDs
n=133 Participants
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
|
|---|---|---|
|
Subject Assessment of Normal Function / Activity
Day 2 - normal no pain (N =135, 133)
|
5 participants
|
2 participants
|
|
Subject Assessment of Normal Function / Activity
Day 2 - normal with pain
|
40 participants
|
30 participants
|
|
Subject Assessment of Normal Function / Activity
Day 2 - mildly restricted
|
59 participants
|
55 participants
|
|
Subject Assessment of Normal Function / Activity
Day 2 - moderately restricted
|
19 participants
|
39 participants
|
|
Subject Assessment of Normal Function / Activity
Day 2 - severely restricted
|
12 participants
|
7 participants
|
|
Subject Assessment of Normal Function / Activity
Day 3 - normal no pain (N = 135, 131)
|
18 participants
|
13 participants
|
|
Subject Assessment of Normal Function / Activity
Day 3 - normal with pain
|
52 participants
|
46 participants
|
|
Subject Assessment of Normal Function / Activity
Day 3 - mildly restricted
|
49 participants
|
57 participants
|
|
Subject Assessment of Normal Function / Activity
Day 3 - moderately restricted
|
14 participants
|
11 participants
|
|
Subject Assessment of Normal Function / Activity
Day 3 - severely restricted
|
2 participants
|
4 participants
|
|
Subject Assessment of Normal Function / Activity
Day 7 - normal no pain (N = 133, 125)
|
62 participants
|
43 participants
|
|
Subject Assessment of Normal Function / Activity
Day 7 - normal with pain
|
55 participants
|
68 participants
|
|
Subject Assessment of Normal Function / Activity
Day 7 - mildly restricted
|
11 participants
|
8 participants
|
|
Subject Assessment of Normal Function / Activity
Day 7 - moderately restricted
|
4 participants
|
3 participants
|
|
Subject Assessment of Normal Function / Activity
Day 7 - severely restricted
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Days 1, 3 and 7Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
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
Outcome measures
| Measure |
Celecoxib
n=135 Participants
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
|
nsNSAIDs
n=133 Participants
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
|
|---|---|---|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 1
Day 2 (N = 134, 133)
|
5.71 scores on a scale
Standard Deviation 2.04
|
5.90 scores on a scale
Standard Deviation 2.06
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 1
Day 3 (N = 135, 131)
|
3.81 scores on a scale
Standard Deviation 1.84
|
4.44 scores on a scale
Standard Deviation 1.91
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 1
Day 7 (N = 133, 125)
|
2.08 scores on a scale
Standard Deviation 1.93
|
2.38 scores on a scale
Standard Deviation 1.78
|
SECONDARY outcome
Timeframe: Days 2, 3 and 7Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
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
Outcome measures
| Measure |
Celecoxib
n=135 Participants
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
|
nsNSAIDs
n=133 Participants
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
|
|---|---|---|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 2
Day 2 (N = 133, 133)
|
3.25 scores on a scale
Standard Deviation 1.83
|
3.36 scores on a scale
Standard Deviation 1.88
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 2
Day 3 (N = 135, 131)
|
2.07 scores on a scale
Standard Deviation 1.68
|
2.40 scores on a scale
Standard Deviation 1.64
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 2
Day 7 (N = 133, 125)
|
0.83 scores on a scale
Standard Deviation 1.26
|
1.16 scores on a scale
Standard Deviation 1.43
|
SECONDARY outcome
Timeframe: Days 2, 3 and 7Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
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
Outcome measures
| Measure |
Celecoxib
n=135 Participants
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
|
nsNSAIDs
n=133 Participants
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
|
|---|---|---|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 3
Day 2 (N = 134, 133)
|
4.34 scores on a scale
Standard Deviation 1.79
|
4.41 scores on a scale
Standard Deviation 1.90
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 3
Day 3 (N = 135, 131)
|
2.90 scores on a scale
Standard Deviation 1.70
|
3.26 scores on a scale
Standard Deviation 1.63
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 3
Day 7 (N = 133, 125)
|
1.41 scores on a scale
Standard Deviation 1.56
|
1.74 scores on a scale
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: Days 2, 3 and 7Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
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
Outcome measures
| Measure |
Celecoxib
n=135 Participants
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
|
nsNSAIDs
n=133 Participants
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
|
|---|---|---|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 4
Day 2 (N = 134, 133)
|
3.64 scores on a scale
Standard Deviation 2.05
|
4.23 scores on a scale
Standard Deviation 2.26
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 4
Day 3 (N =135, 131)
|
2.58 scores on a scale
Standard Deviation 1.81
|
2.92 scores on a scale
Standard Deviation 1.78
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 4
Day 7 (N = 133, 125)
|
1.14 scores on a scale
Standard Deviation 1.56
|
1.43 scores on a scale
Standard Deviation 1.55
|
SECONDARY outcome
Timeframe: Days 2, 3 and 7Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
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
Outcome measures
| Measure |
Celecoxib
n=135 Participants
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
|
nsNSAIDs
n=133 Participants
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
|
|---|---|---|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Index
Day 2 (N = 134, 133)
|
4.24 scores on a scale
Standard Deviation 1.66
|
4.48 scores on a scale
Standard Deviation 1.84
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Index
Day 3 (N = 135, 131)
|
2.84 scores on a scale
Standard Deviation 1.61
|
3.26 scores on a scale
Standard Deviation 1.57
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Index
Day 7 (N = 133, 125)
|
1.37 scores on a scale
Standard Deviation 1.47
|
1.68 scores on a scale
Standard Deviation 1.44
|
SECONDARY outcome
Timeframe: Days 2, 3 and 7Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
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
Outcome measures
| Measure |
Celecoxib
n=135 Participants
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
|
nsNSAIDs
n=133 Participants
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
|
|---|---|---|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5A
Day 2 (N = 134, 133)
|
5.40 scores on a scale
Standard Deviation 2.52
|
5.37 scores on a scale
Standard Deviation 2.62
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5A
Day 3 (N = 135, 131)
|
3.65 scores on a scale
Standard Deviation 2.64
|
4.07 scores on a scale
Standard Deviation 2.60
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5A
Day 7 (N = 133, 125)
|
1.78 scores on a scale
Standard Deviation 2.13
|
1.90 scores on a scale
Standard Deviation 1.94
|
SECONDARY outcome
Timeframe: Days 2, 3 and 7Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
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
Outcome measures
| Measure |
Celecoxib
n=135 Participants
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
|
nsNSAIDs
n=133 Participants
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
|
|---|---|---|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5B
Day 2 (N = 134, 133)
|
3.72 scores on a scale
Standard Deviation 2.95
|
3.64 scores on a scale
Standard Deviation 2.87
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5B
Day 3 (N = 135, 131)
|
2.43 scores on a scale
Standard Deviation 2.41
|
2.38 scores on a scale
Standard Deviation 2.60
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5B
Day 7 (N = 133, 125)
|
1.17 scores on a scale
Standard Deviation 2.06
|
1.26 scores on a scale
Standard Deviation 2.01
|
SECONDARY outcome
Timeframe: Days 2, 3 and 7Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
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
Outcome measures
| Measure |
Celecoxib
n=135 Participants
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
|
nsNSAIDs
n=133 Participants
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
|
|---|---|---|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5C
Day 2 (N = 134, 133)
|
5.10 scores on a scale
Standard Deviation 2.76
|
5.11 scores on a scale
Standard Deviation 2.74
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5C
Day 3 (N = 135, 131)
|
3.58 scores on a scale
Standard Deviation 2.62
|
3.69 scores on a scale
Standard Deviation 2.67
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5C
Day 7 (N = 133, 125)
|
1.65 scores on a scale
Standard Deviation 2.19
|
1.62 scores on a scale
Standard Deviation 1.93
|
SECONDARY outcome
Timeframe: Days 2, 3 and 7Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
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
Outcome measures
| Measure |
Celecoxib
n=135 Participants
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
|
nsNSAIDs
n=133 Participants
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
|
|---|---|---|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5D
Day 2 (N = 134, 133)
|
5.29 scores on a scale
Standard Deviation 2.95
|
5.39 scores on a scale
Standard Deviation 2.76
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5D
Day 3 (N = 135, 131)
|
4.04 scores on a scale
Standard Deviation 2.92
|
4.04 scores on a scale
Standard Deviation 2.88
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5D
Day 7 (N = 133, 125)
|
1.84 scores on a scale
Standard Deviation 2.42
|
1.87 scores on a scale
Standard Deviation 2.11
|
SECONDARY outcome
Timeframe: Days 2, 3 and 7Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
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
Outcome measures
| Measure |
Celecoxib
n=135 Participants
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
|
nsNSAIDs
n=133 Participants
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
|
|---|---|---|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5E
Day 2 (N = 134, 133)
|
2.70 scores on a scale
Standard Deviation 2.78
|
2.67 scores on a scale
Standard Deviation 2.68
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5E
Day 3 (N = 135, 131)
|
1.81 scores on a scale
Standard Deviation 2.26
|
1.69 scores on a scale
Standard Deviation 2.26
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5E
Day 7 (N = 133, 125)
|
0.80 scores on a scale
Standard Deviation 1.70
|
0.78 scores on a scale
Standard Deviation 1.48
|
SECONDARY outcome
Timeframe: Days 2, 3 and 7Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
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
Outcome measures
| Measure |
Celecoxib
n=135 Participants
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
|
nsNSAIDs
n=133 Participants
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
|
|---|---|---|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5F
Day 2 (N = 134, 133)
|
2.97 scores on a scale
Standard Deviation 2.88
|
2.87 scores on a scale
Standard Deviation 2.64
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5F
Day 3 (N = 135, 131)
|
1.90 scores on a scale
Standard Deviation 2.40
|
1.86 scores on a scale
Standard Deviation 2.28
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5F
Day 7 (N = 133, 125)
|
0.68 scores on a scale
Standard Deviation 1.77
|
0.82 scores on a scale
Standard Deviation 1.61
|
SECONDARY outcome
Timeframe: Days 2, 3 and 7Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
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
Outcome measures
| Measure |
Celecoxib
n=135 Participants
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
|
nsNSAIDs
n=133 Participants
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
|
|---|---|---|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5G
Day 2 (N = 134, 133)
|
3.33 scores on a scale
Standard Deviation 3.17
|
2.99 scores on a scale
Standard Deviation 2.81
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5G
Day 3 (N = 135, 131)
|
2.13 scores on a scale
Standard Deviation 2.69
|
2.06 scores on a scale
Standard Deviation 2.48
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5G
Day 7 (N = 133, 125)
|
1.07 scores on a scale
Standard Deviation 1.98
|
1.10 scores on a scale
Standard Deviation 1.80
|
SECONDARY outcome
Timeframe: Days 2, 3 and 7Population: Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
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
Outcome measures
| Measure |
Celecoxib
n=135 Participants
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
|
nsNSAIDs
n=133 Participants
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
|
|---|---|---|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Index
Day 2 (N = 134, 133)
|
4.07 scores on a scale
Standard Deviation 2.34
|
4.01 scores on a scale
Standard Deviation 2.12
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Index
Day 3 (N = 135, 131)
|
2.79 scores on a scale
Standard Deviation 2.15
|
2.83 scores on a scale
Standard Deviation 2.07
|
|
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Index
Day 7 (N = 133, 125)
|
1.28 scores on a scale
Standard Deviation 1.81
|
1.33 scores on a scale
Standard Deviation 1.54
|
Adverse Events
Celecoxib
nsNSAIDs
Serious adverse events
| Measure |
Celecoxib
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
|
nsNSAIDs
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
|
|---|---|---|
|
Infections and infestations
Dengue fever
|
0.00%
0/141
|
0.73%
1/137
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/141
|
0.73%
1/137
|
Other adverse events
| Measure |
Celecoxib
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
|
nsNSAIDs
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/141
|
1.5%
2/137
|
|
Gastrointestinal disorders
Diarrhoea
|
0.71%
1/141
|
1.5%
2/137
|
|
Gastrointestinal disorders
Dyspepsia
|
0.71%
1/141
|
1.5%
2/137
|
|
Gastrointestinal disorders
Gastritis
|
1.4%
2/141
|
3.6%
5/137
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.71%
1/141
|
2.2%
3/137
|
|
Gastrointestinal disorders
Nausea
|
0.71%
1/141
|
1.5%
2/137
|
|
Nervous system disorders
Headache
|
2.1%
3/141
|
0.00%
0/137
|
|
Nervous system disorders
Somnolence
|
3.5%
5/141
|
1.5%
2/137
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
- Publication restrictions are in place
Restriction type: OTHER