Trial Outcomes & Findings for An Open-Label Study Of Celecoxib In Patients With Posttraumatic Pain (NCT NCT00976716)
NCT ID: NCT00976716
Last Updated: 2021-02-02
Results Overview
The patient impression of the study medication was entered in the patient diary based on the following categories: "excellent," "good," "fair" and "poor." Efficacy was based on the patient impression of the study medication ("excellent" and "good") from the first study medication until Final Visit.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
80 participants
Primary outcome timeframe
8 days
Results posted on
2021-02-02
Participant Flow
Subjects were screened at 12 centers in Japan.
Participant milestones
| Measure |
Celecoxib
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID (twice daily) for up to 7 days from Day 2.
|
|---|---|
|
Overall Study
STARTED
|
80
|
|
Overall Study
COMPLETED
|
79
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Celecoxib
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID (twice daily) for up to 7 days from Day 2.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
An Open-Label Study Of Celecoxib In Patients With Posttraumatic Pain
Baseline characteristics by cohort
| Measure |
Celecoxib
n=80 Participants
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
|
|---|---|
|
Age, Continuous
|
37.1 Years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 daysPopulation: The full analysis set (FAS) consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the last observation carried forward (LOCF) was used.
The patient impression of the study medication was entered in the patient diary based on the following categories: "excellent," "good," "fair" and "poor." Efficacy was based on the patient impression of the study medication ("excellent" and "good") from the first study medication until Final Visit.
Outcome measures
| Measure |
Celecoxib
n=80 Participants
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
|
|---|---|
|
Patient Impressions at Final Visit (the Number of Participants Who Have Rated "Excellent" and "Good")
|
70 Participants
|
SECONDARY outcome
Timeframe: 6 hours post first dose and before sleep on Day 1, before sleep on Day 2, Day 4 (Visit 2) and Day 8 (Visit 3)Population: The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints.
The patient impression of the study medication was entered in the patient diary based on the following categories: "excellent," "good," "fair" and "poor." Efficacy was based on the patient impression of the study medication ("excellent" and "good") from the first study medication until each time point.
Outcome measures
| Measure |
Celecoxib
n=80 Participants
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
|
|---|---|
|
Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated "Excellent" and "Good")
Day 1, 6 hours post first dose (n=80)
|
44 Participants
|
|
Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated "Excellent" and "Good")
Day 1, before sleep (n=80)
|
48 Participants
|
|
Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated "Excellent" and "Good")
Day 2, before sleep (n=80)
|
55 Participants
|
|
Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated "Excellent" and "Good")
Visit 2 (Day 4), (n=80)
|
60 Participants
|
|
Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated "Excellent" and "Good")
Visit 3 (Day 8), (n=68)
|
60 Participants
|
SECONDARY outcome
Timeframe: Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)Population: The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.
The PI of pain at rest (spontaneous pain) was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=worst possible pain.
Outcome measures
| Measure |
Celecoxib
n=80 Participants
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
|
|---|---|
|
Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose
Baseline (n=80)
|
59.9 mm
Standard Deviation 11.4
|
|
Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose
Day 1, 2 hours post first dose (n=80)
|
47.3 mm
Standard Deviation 19.5
|
|
Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose
Day 1, 4 hours post first dose (n=80)
|
42.5 mm
Standard Deviation 20.5
|
|
Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose
Day 1, 6 hours post first dose (n=80)
|
40.3 mm
Standard Deviation 20.9
|
|
Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose
Day 1, before sleep (n=80)
|
38.1 mm
Standard Deviation 20.0
|
|
Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose
Day 2, on awakening (n=80)
|
34.8 mm
Standard Deviation 21.5
|
|
Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose
Day 2, before sleep (n=80)
|
29.0 mm
Standard Deviation 22.0
|
|
Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose
Day 3, on awakening (n=80)
|
24.8 mm
Standard Deviation 20.0
|
|
Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose
Day 3, before sleep (n=78)
|
21.8 mm
Standard Deviation 19.1
|
|
Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose
Day 4, on awakening (n=78)
|
18.4 mm
Standard Deviation 19.6
|
|
Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose
Day 4, before sleep (n=73)
|
17.8 mm
Standard Deviation 18.9
|
|
Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose
Day 5, on awakening (n=73)
|
15.3 mm
Standard Deviation 18.0
|
|
Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose
Day 5, before sleep (n=68)
|
15.0 mm
Standard Deviation 18.7
|
|
Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose
Day 6, on awakening (n=68)
|
12.4 mm
Standard Deviation 17.2
|
|
Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose
Day 6, before sleep (n=68)
|
11.6 mm
Standard Deviation 17.3
|
|
Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose
Day 7, on awakening (n=68)
|
11.3 mm
Standard Deviation 18.1
|
|
Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose
Day 7, before sleep (n=55)
|
9.7 mm
Standard Deviation 16.2
|
|
Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose
Day 8, on awakening (n=55)
|
8.6 mm
Standard Deviation 13.3
|
|
Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose
Visit 3 (Day 8) (n=73)
|
7.2 mm
Standard Deviation 13.0
|
|
Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose
Final Visit (LOCF, n=80)
|
7.3 mm
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)Population: The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.
The PI of pain on active movement was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=worst possible pain.
Outcome measures
| Measure |
Celecoxib
n=79 Participants
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
|
|---|---|
|
PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose
Day 1, before sleep (n=77)
|
49.3 mm
Standard Deviation 21.0
|
|
PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose
Baseline (n=79)
|
75.5 mm
Standard Deviation 12.7
|
|
PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose
Day 1, 2 hours post first dose (n=77)
|
61.4 mm
Standard Deviation 20.2
|
|
PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose
Day 1, 4 hours post first dose (n=77)
|
55.3 mm
Standard Deviation 21.0
|
|
PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose
Day 1, 6 hours post first dose (n=77)
|
51.5 mm
Standard Deviation 20.6
|
|
PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose
Day 2, on awakening (n=77)
|
45.5 mm
Standard Deviation 21.4
|
|
PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose
Day 2, before sleep (n=77)
|
39.7 mm
Standard Deviation 22.6
|
|
PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose
Day 3, on awakening (n=77)
|
35.5 mm
Standard Deviation 22.3
|
|
PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose
Day 3, before sleep (n=75)
|
32.4 mm
Standard Deviation 21.8
|
|
PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose
Day 4, on awakening (n=75)
|
27.2 mm
Standard Deviation 22.9
|
|
PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose
Day 4, before sleep (n=70)
|
26.4 mm
Standard Deviation 21.0
|
|
PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose
Day 5, on awakening (n=70)
|
23.5 mm
Standard Deviation 21.4
|
|
PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose
Day 5, before sleep (n=66)
|
23.2 mm
Standard Deviation 22.0
|
|
PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose
Day 6, on awakening (n=66)
|
19.2 mm
Standard Deviation 20.4
|
|
PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose
Day 6, before sleep (n=66)
|
18.2 mm
Standard Deviation 20.1
|
|
PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose
Day 7, on awakening (n=66)
|
17.1 mm
Standard Deviation 21.7
|
|
PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose
Day 7, before sleep (n=55)
|
15.5 mm
Standard Deviation 20.7
|
|
PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose
Day 8, on awakening (n=55)
|
14.3 mm
Standard Deviation 20.0
|
|
PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose
Visit 3 (Day8) (n=71)
|
12.1 mm
Standard Deviation 18.7
|
|
PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose
Final Visit (LOCF, n=78)
|
11.8 mm
Standard Deviation 18.7
|
SECONDARY outcome
Timeframe: Two, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)Population: The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.
The PID score was obtained by subtracting the PI (by VAS: 0 mm=no pain, 100 mm=worst possible pain) at each time point from the Baseline PI score. Increase in PID scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain.
Outcome measures
| Measure |
Celecoxib
n=80 Participants
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
|
|---|---|
|
Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose
Visit 3 (Day 8) (n=73)
|
52.4 mm
Standard Deviation 15.5
|
|
Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose
Day 1, 2 hours post first dose (n=80)
|
12.6 mm
Standard Deviation 14.8
|
|
Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose
Day 1, 4 hours post first dose (n=80)
|
17.4 mm
Standard Deviation 16.0
|
|
Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose
Day 1, 6 hours post first dose (n=80)
|
19.6 mm
Standard Deviation 16.3
|
|
Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose
Day 1, before sleep (n=80)
|
21.8 mm
Standard Deviation 16.8
|
|
Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose
Day 2, on awakening (n=80)
|
25.1 mm
Standard Deviation 19.1
|
|
Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose
Day 2, before sleep (n=80)
|
30.9 mm
Standard Deviation 20.8
|
|
Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose
Day 3, on awakening (n=80)
|
35.1 mm
Standard Deviation 18.7
|
|
Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose
Day 3, before sleep (n=78)
|
37.9 mm
Standard Deviation 18.8
|
|
Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose
Day 4, on awakening (n=78)
|
41.3 mm
Standard Deviation 19.7
|
|
Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose
Day 4, before sleep (n=73)
|
41.8 mm
Standard Deviation 19.2
|
|
Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose
Day 5, on awakening (n=73)
|
44.3 mm
Standard Deviation 18.4
|
|
Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose
Day 5, before sleep (n=68)
|
45.4 mm
Standard Deviation 19.5
|
|
Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose
Day 6, on awakening (n=68)
|
48.0 mm
Standard Deviation 17.7
|
|
Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose
Day 6, before sleep (n=68)
|
48.8 mm
Standard Deviation 18.1
|
|
Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose
Day 7, on awakening (n=68)
|
49.2 mm
Standard Deviation 19.0
|
|
Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose
Day 7, before sleep (n=55)
|
50.2 mm
Standard Deviation 18.7
|
|
Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose
Day 8, on awakening (n=55)
|
51.3 mm
Standard Deviation 17.3
|
|
Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose
Final Visit (LOCF, n=80)
|
52.6 mm
Standard Deviation 15.2
|
SECONDARY outcome
Timeframe: 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)Population: The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.
The PID score was obtained by subtracting the PI at each time point from the Baseline PI score. Increase in scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain.
Outcome measures
| Measure |
Celecoxib
n=79 Participants
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
|
|---|---|
|
PID in Pain on Active Movement Within 8 Days Post-first Dose
Day 1, 2 hours post first dose (n=77)
|
14.3 mm
Standard Deviation 16.6
|
|
PID in Pain on Active Movement Within 8 Days Post-first Dose
Day 1, 4 hours post first dose (n=77)
|
20.4 mm
Standard Deviation 17.1
|
|
PID in Pain on Active Movement Within 8 Days Post-first Dose
Day 1, 6 hours post first dose (n=77)
|
24.3 mm
Standard Deviation 17.5
|
|
PID in Pain on Active Movement Within 8 Days Post-first Dose
Day 1, before sleep (n=77)
|
26.5 mm
Standard Deviation 17.5
|
|
PID in Pain on Active Movement Within 8 Days Post-first Dose
Day 2, on awakening (n=77)
|
30.3 mm
Standard Deviation 19.2
|
|
PID in Pain on Active Movement Within 8 Days Post-first Dose
Day 2, before sleep (n=77)
|
36.1 mm
Standard Deviation 22.0
|
|
PID in Pain on Active Movement Within 8 Days Post-first Dose
Day 3, on awakening (n=77)
|
40.2 mm
Standard Deviation 21.2
|
|
PID in Pain on Active Movement Within 8 Days Post-first Dose
Day 3, before sleep (n=75)
|
43.2 mm
Standard Deviation 21.5
|
|
PID in Pain on Active Movement Within 8 Days Post-first Dose
Day 4, on awakening (n=75)
|
48.5 mm
Standard Deviation 22.3
|
|
PID in Pain on Active Movement Within 8 Days Post-first Dose
Day 4, before sleep (n=70)
|
49.5 mm
Standard Deviation 20.6
|
|
PID in Pain on Active Movement Within 8 Days Post-first Dose
Day 5, on awakening (n=70)
|
52.5 mm
Standard Deviation 20.8
|
|
PID in Pain on Active Movement Within 8 Days Post-first Dose
Day 5, before sleep (n=66)
|
53.5 mm
Standard Deviation 21.6
|
|
PID in Pain on Active Movement Within 8 Days Post-first Dose
Day 6, on awakening (n=66)
|
57.5 mm
Standard Deviation 19.7
|
|
PID in Pain on Active Movement Within 8 Days Post-first Dose
Day 6, before sleep (n=66)
|
58.4 mm
Standard Deviation 19.9
|
|
PID in Pain on Active Movement Within 8 Days Post-first Dose
Day 7, on awakening (n=66)
|
59.6 mm
Standard Deviation 21.4
|
|
PID in Pain on Active Movement Within 8 Days Post-first Dose
Day 7, before sleep (n=55)
|
62.1 mm
Standard Deviation 20.6
|
|
PID in Pain on Active Movement Within 8 Days Post-first Dose
Day 8, on awakening (n=55)
|
63.3 mm
Standard Deviation 20.6
|
|
PID in Pain on Active Movement Within 8 Days Post-first Dose
Visit 3 (Day 8) (n=71)
|
63.6 mm
Standard Deviation 18.6
|
|
PID in Pain on Active Movement Within 8 Days Post-first Dose
Final Visit (LOCF, n=78)
|
63.7 mm
Standard Deviation 18.1
|
SECONDARY outcome
Timeframe: 6 hoursPopulation: The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement. If a patient withdrew the study before 6 hours on Day 1 and the measurement of the PI at 6 hours on Day 1 was missing, the LOCF method was used for the PI at 6 hours on Day 1 to derive the SPID.
The SPID was derived according to the following rule: each PID was weighted by the width of time interval between previous and current time points in hours and summed up to 6 hours post-first dose
Outcome measures
| Measure |
Celecoxib
n=80 Participants
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
|
|---|---|
|
Sum of Pain Intensity Differences (SPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose
Pain at rest (n=80)
|
99.3 mm
Interval 79.9 to 118.7
|
|
Sum of Pain Intensity Differences (SPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose
Pain on active movement (n=77)
|
118.2 mm
Interval 96.7 to 139.6
|
SECONDARY outcome
Timeframe: Two, 4 and 6 hours post first dosePopulation: The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints.
The PPID was obtained by subtracting the maximum value of pain intensity (PI) at a time point among 2 to 6 hours post first dose from baseline value of PI for each patient.
Outcome measures
| Measure |
Celecoxib
n=80 Participants
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
|
|---|---|
|
Peak Pain Intensity Difference (PPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose
Pain at rest (n=80)
|
22.2 mm
Interval 18.6 to 25.8
|
|
Peak Pain Intensity Difference (PPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose
Pain on active movement (n=77)
|
26.7 mm
Interval 22.6 to 30.7
|
SECONDARY outcome
Timeframe: Baseline, Days 4 (Visit 2) and 8 (Visit 3)Population: The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.
The investigator assessed the swelling, using the categories "None," "Mild," "Moderate," and "Severe" at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit.
Outcome measures
| Measure |
Celecoxib
n=80 Participants
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
|
|---|---|
|
Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose
None at Baseline (n=80)
|
0 Participants
|
|
Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose
None at Visit 2 (Day 4) (n=80)
|
5 Participants
|
|
Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose
None at Visit 3 (Day 8) (n=68)
|
38 Participants
|
|
Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose
None at Final Visit (n=80)
|
41 Participants
|
|
Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose
Mild at Baseline (n=80)
|
24 Participants
|
|
Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose
Mild at Visit 2 (Day 4) (n=80)
|
69 Participants
|
|
Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose
Mild at Visit 3 (Day 8) (n=68)
|
26 Participants
|
|
Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose
Mild at Final Visit (n=80)
|
35 Participants
|
|
Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose
Moderate at Baseline (n=80)
|
48 Participants
|
|
Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose
Moderate at Visit 2 (Day 4) (n=80)
|
5 Participants
|
|
Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose
Moderate at Visit 3 (Day 8) (n=68)
|
4 Participants
|
|
Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose
Moderate at Final Visit (n=80)
|
4 Participants
|
|
Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose
Severe at Baseline (n=80)
|
8 Participants
|
|
Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose
Severe at Visit 2 (Day 4) (n=80)
|
1 Participants
|
|
Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose
Severe at Visit 3 (Day 8) (n=68)
|
0 Participants
|
|
Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose
Severe at Final Visit (n=80)
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Days 4 (Visit 2) and 8 (Visit 3)Population: The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.
The investigator assessed the redness, using the categories "None," "Mild," "Moderate," and "Severe" at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit.
Outcome measures
| Measure |
Celecoxib
n=80 Participants
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
|
|---|---|
|
Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose
None at Baseline (n=80)
|
16 Participants
|
|
Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose
None at Visit 2 (Day 4) (n=80)
|
51 Participants
|
|
Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose
None at Visit 3 (Day 8) (n=68)
|
64 Participants
|
|
Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose
None at Final Visit (n=80)
|
73 Participants
|
|
Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose
Mild at Baseline (n=80)
|
40 Participants
|
|
Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose
Mild at Visit 2 (Day 4) (n=80)
|
28 Participants
|
|
Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose
Mild at Visit 3 (Day 8) (n=68)
|
4 Participants
|
|
Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose
Mild at Final Visit (n=80)
|
7 Participants
|
|
Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose
Moderate at Baseline (n=80)
|
19 Participants
|
|
Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose
Moderate at Visit 2 (Day 4) (n=80)
|
1 Participants
|
|
Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose
Moderate at Visit 3 (Day 8) (n=68)
|
0 Participants
|
|
Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose
Moderate at Final Visit (n=80)
|
0 Participants
|
|
Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose
Severe at Baseline (n=80)
|
5 Participants
|
|
Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose
Severe at Visit 2 (Day 4) (n=80)
|
0 Participants
|
|
Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose
Severe at Visit 3 (Day 8) (n=68)
|
0 Participants
|
|
Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose
Severe at Final Visit (n=80)
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Days 4 (Visit 2) and 8 (Visit 3)Population: The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.
The investigator assessed the localized warmth, using the categories "None," "Mild," "Moderate," and "Severe" at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit.
Outcome measures
| Measure |
Celecoxib
n=80 Participants
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
|
|---|---|
|
Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose
None at Baseine (n=80)
|
8 Participants
|
|
Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose
None at Visit 2 (Day 4) (n=80)
|
63 Participants
|
|
Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose
None at Visit 3 (Day 8) (n=68)
|
66 Participants
|
|
Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose
None at Final Visit (n=80)
|
76 Participants
|
|
Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose
Mild at Baseine (n=80)
|
43 Participants
|
|
Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose
Mild at Visit 2 (Day 4) (n=80)
|
17 Participants
|
|
Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose
Mild at Visit 3 (Day 8) (n=68)
|
2 Participants
|
|
Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose
Mild at Final Visit (n=80)
|
4 Participants
|
|
Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose
Moderate at Baseine (n=80)
|
23 Participants
|
|
Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose
Moderate at Visit 2 (Day 4) (n=80)
|
0 Participants
|
|
Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose
Moderate at Visit 3 (Day 8) (n=68)
|
0 Participants
|
|
Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose
Moderate at Final Visit (n=80)
|
0 Participants
|
|
Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose
Severe at Baseine (n=80)
|
6 Participants
|
|
Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose
Severe at Visit 2 (Day 4) (n=80)
|
0 Participants
|
|
Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose
Severe at Visit 3 (Day 8) (n=68)
|
0 Participants
|
|
Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose
Severe at Final Visit (n=80)
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 daysPopulation: The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints.
The number of subjects who withdrew due to insufficient clinical response was evaluated.
Outcome measures
| Measure |
Celecoxib
n=80 Participants
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
|
|---|---|
|
Withdrawal Due to Lack of Efficacy
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 daysPopulation: The safety analysis set consisted of all patients who had taken at least one study medication.
The number of subjects who experienced adverse events (AEs; all-causality and treatment-related) based on safety assessment was summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized.
Outcome measures
| Measure |
Celecoxib
n=80 Participants
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
|
|---|---|
|
Summary of Adverse Events
AEs: all-causality
|
10 Participants
|
|
Summary of Adverse Events
AEs: treatment-related
|
8 Participants
|
|
Summary of Adverse Events
Severe AEs: all-causality
|
0 Participants
|
|
Summary of Adverse Events
Severe AEs: treatment-realted
|
0 Participants
|
|
Summary of Adverse Events
Serious AEs: all-causality
|
0 Participants
|
|
Summary of Adverse Events
Serious AEs: treatment-related
|
0 Participants
|
|
Summary of Adverse Events
Discontinuation due to all-causality AEs
|
1 Participants
|
|
Summary of Adverse Events
Discontinuation due to treatment-related AEs
|
1 Participants
|
|
Summary of Adverse Events
DR/TD due to all-causality AEs
|
0 Participants
|
|
Summary of Adverse Events
DR/TD due to treatment-related AEs
|
0 Participants
|
Adverse Events
Celecoxib
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Celecoxib
n=80 participants at risk
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/80 • 8 days
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.2%
1/80 • 8 days
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
1.2%
1/80 • 8 days
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
1.2%
1/80 • 8 days
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Beta 2 microglobulin urine increased
|
6.2%
5/80 • 8 days
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Beta-N-acetyl-D-glucosaminidase increased
|
3.8%
3/80 • 8 days
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood bilirubin increased
|
1.2%
1/80 • 8 days
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatine phosphokinase increased
|
3.8%
3/80 • 8 days
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.5%
2/80 • 8 days
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Urobilin urine present
|
1.2%
1/80 • 8 days
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.2%
1/80 • 8 days
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER