Adults 18 to 18, any sex, with Pharyngitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First DosePrimary· 2 hours Post-First Dose
Based on the Pain Intensity scores measured on a Visual Analogue Scale (PI-VAS: 0mm=no pain,100mm=worst possible pain), assessed by the subjects, the SPID2 is the area under the curve (AUC) over the 2-hour period post-first dose of the Pain Intensity Difference (PID) scores using the trapezoidal rule.
Group
Value
95% CI
Celecoxib 100mg (Pooled)
21.0
± 2.20
Placebo
9.4
± 2.21
Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First DoseSecondary· Within First 6 hours Post-First Dose
Pain intensity (PI) on Swallowing as Measured by PI-VAS scale: 0mm=no pain, 100mm=worst possible pain. Sore throat 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.
15 min
Group
Value
95% CI
Celecoxib 50mg/50mg
1.62
± 0.64
Celecoxib 100mg (Pooled)
1.92
± 0.64
Placebo
0.40
± 0.64
30 min
Group
Value
95% CI
Celecoxib 50mg/50mg
4.70
± 0.90
Celecoxib 100mg (Pooled)
4.93
± 0.90
Placebo
2.14
± 0.91
45 min
Group
Value
95% CI
Celecoxib 50mg/50mg
9.57
± 1.22
Celecoxib 100mg (Pooled)
7.05
± 1.23
Placebo
3.85
± 1.24
60 min
Group
Value
95% CI
Celecoxib 50mg/50mg
12.18
± 1.47
Celecoxib 100mg (Pooled)
11.43
± 1.47
Placebo
5.34
± 1.48
75 min
Group
Value
95% CI
Celecoxib 50mg/50mg
17.24
± 1.62
Celecoxib 100mg (Pooled)
13.24
± 1.62
Placebo
6.60
± 1.64
90 min
Group
Value
95% CI
Celecoxib 50mg/50mg
22.39
± 1.88
Celecoxib 100mg (Pooled)
17.00
± 1.88
Placebo
6.75
± 1.90
1.75 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
24.68
± 1.99
Celecoxib 100mg (Pooled)
18.80
± 1.99
Placebo
7.41
± 2.01
2 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
26.63
± 2.19
Celecoxib 100mg (Pooled)
21.51
± 2.19
Placebo
8.06
± 2.21
Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First DoseSecondary· 7 to 24 hours
Pain intensity (PI) on Swallowing as Measured by PI-VAS scale: 0mm=no pain, 100mm=worst possible pain. PID score was obtained by subtracting the PI at each time point from the Baseline PI score. An increase in scores indicated a lessening of subjects' pain as compared to Baseline scores, thus, higher scores indicated a greater reduction in pain.
7 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
20.82
± 2.30
Celecoxib 100mg/Placebo
22.01
± 3.26
Celecoxib 100mg/50mg
18.34
± 3.25
Placebo
9.32
± 2.33
8 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
20.39
± 2.29
Celecoxib 100mg/Placebo
20.81
± 3.24
Celecoxib 100mg/50mg
19.93
± 3.23
Placebo
8.12
± 2.31
9 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
21.39
± 2.36
Celecoxib 100mg/Placebo
19.18
± 3.35
Celecoxib 100mg/50mg
18.87
± 3.33
Placebo
9.92
± 2.38
10 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
21.26
± 2.40
Celecoxib 100mg/Placebo
18.02
± 3.40
Celecoxib 100mg/50mg
18.06
± 3.39
Placebo
9.56
± 2.42
11 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
19.65
± 2.40
Celecoxib 100mg/Placebo
17.43
± 3.40
Celecoxib 100mg/50mg
18.99
± 3.39
Placebo
9.29
± 2.43
12 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
19.01
± 2.50
Celecoxib 100mg/Placebo
15.01
± 3.54
Celecoxib 100mg/50mg
20.22
± 3.52
Placebo
8.60
± 2.52
24 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
18.43
± 2.58
Celecoxib 100mg/Placebo
16.50
± 3.66
Celecoxib 100mg/50mg
19.44
± 3.65
Placebo
12.81
± 2.61
Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First DoseSecondary· up to 6 hours
The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The PID \[based on PI-VAS scale: 0mm=no pain, 100mm=worst possible pain\] was calculated as the difference between the pain intensity at the time and at baseline.
15 min
Group
Value
95% CI
Celecoxib 50mg/50mg
0.2
± 0.1
Celecoxib 100mg (Pooled)
0.2
± 0.1
Placebo
0.1
± 0.1
30 min
Group
Value
95% CI
Celecoxib 50mg/50mg
1.0
± 0.2
Celecoxib 100mg (Pooled)
1.1
± 0.2
Placebo
0.4
± 0.2
45 min
Group
Value
95% CI
Celecoxib 50mg/50mg
2.8
± 0.4
Celecoxib 100mg (Pooled)
2.6
± 0.4
Placebo
1.1
± 0.5
60 min
Group
Value
95% CI
Celecoxib 50mg/50mg
5.5
± 0.7
Celecoxib 100mg (Pooled)
4.9
± 0.7
Placebo
2.3
± 0.7
75 min
Group
Value
95% CI
Celecoxib 50mg/50mg
9.2
± 1.0
Celecoxib 100mg (Pooled)
8.0
± 1.0
Placebo
3.8
± 1.0
90 min
Group
Value
95% CI
Celecoxib 50mg/50mg
14.1
± 1.4
Celecoxib 100mg (Pooled)
11.8
± 1.4
Placebo
5.4
± 1.4
1.75 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
20.0
± 1.8
Celecoxib 100mg (Pooled)
16.2
± 1.8
Placebo
7.2
± 1.8
2 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
26.4
± 2.3
Celecoxib 100mg (Pooled)
21.3
± 2.3
Placebo
9.1
± 2.3
Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First DoseSecondary· 7 to 24 hours
The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The PID \[based on PI-VAS scale: 0mm=no pain, 100mm=worst possible pain\] was calculated as the difference between the pain intensity at the time and at baseline.
7 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
149.2
± 12.4
Celecoxib 100 mg / Placebo
151.8
± 17.5
Celecoxib 100mg / 50mg
111.6
± 17.5
Placebo
56.6
± 12.5
8 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
169.8
± 14.3
Celecoxib 100 mg / Placebo
173.2
± 20.3
Celecoxib 100mg / 50mg
130.8
± 20.2
Placebo
65.4
± 14.5
9 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
190.7
± 16.3
Celecoxib 100 mg / Placebo
193.2
± 23.1
Celecoxib 100mg / 50mg
150.2
± 23.0
Placebo
74.4
± 16.5
10 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
212.0
± 18.2
Celecoxib 100 mg / Placebo
211.8
± 25.9
Celecoxib 100mg / 50mg
168.6
± 25.8
Placebo
84.1
± 18.4
11 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
232.4
± 20.2
Celecoxib 100 mg / Placebo
229.5
± 28.7
Celecoxib 100mg / 50mg
187.2
± 28.6
Placebo
93.5
± 20.5
12 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
251.8
± 22.3
Celecoxib 100 mg / Placebo
245.7
± 31.6
Celecoxib 100mg / 50mg
206.8
± 31.5
Placebo
102.5
± 22.5
24 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
476.4
± 48.7
Celecoxib 100 mg / Placebo
434.8
± 69.0
Celecoxib 100mg / 50mg
444.7
± 68.8
Placebo
231.0
± 49.2
Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First DoseSecondary· within the first 6 hours
STRRS score (scale: 0 no relief to 6 complete relief); a higher pain score indicated a greater reduction in pain.
15 min
Group
Value
95% CI
Celecoxib 50mg/50mg
0.12
± 0.04
Celecoxib 100 mg (Pooled)
0.09
± 0.04
Placebo
0.16
± 0.04
30 min
Group
Value
95% CI
Celecoxib 50mg/50mg
0.41
± 0.07
Celecoxib 100 mg (Pooled)
0.34
± 0.07
Placebo
0.34
± 0.07
45 min
Group
Value
95% CI
Celecoxib 50mg/50mg
0.74
± 0.09
Celecoxib 100 mg (Pooled)
0.69
± 0.09
Placebo
0.52
± 0.09
60 min
Group
Value
95% CI
Celecoxib 50mg/50mg
1.22
± 0.12
Celecoxib 100 mg (Pooled)
1.01
± 0.12
Placebo
0.64
± 0.12
75 min
Group
Value
95% CI
Celecoxib 50mg/50mg
1.58
± 0.13
Celecoxib 100 mg (Pooled)
1.27
± 0.13
Placebo
0.79
± 0.14
90 min
Group
Value
95% CI
Celecoxib 50mg/50mg
1.88
± 0.15
Celecoxib 100 mg (Pooled)
1.61
± 0.15
Placebo
0.88
± 0.15
1.75 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
2.10
± 0.16
Celecoxib 100 mg (Pooled)
1.74
± 0.16
Placebo
0.93
± 0.16
2 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
2.22
± 0.17
Celecoxib 100 mg (Pooled)
1.93
± 0.17
Placebo
0.92
± 0.17
Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First DoseSecondary· 7 to 24 hours
STRRS score (scale: 0 no relief to 6 complete relief); a higher score indicated a greater reduction in pain.
7 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
1.71
± 0.17
Celecoxib 100 mg / Placebo
2.00
± 0.24
Celecoxib 100mg / 50mg
1.67
± 0.24
Placebo
0.93
± 0.17
8 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
1.68
± 0.17
Celecoxib 100 mg / Placebo
1.80
± 0.24
Celecoxib 100mg / 50mg
1.71
± 0.24
Placebo
0.97
± 0.17
9 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
1.69
± 0.17
Celecoxib 100 mg / Placebo
1.76
± 0.25
Celecoxib 100mg / 50mg
1.56
± 0.25
Placebo
1.08
± 0.17
10 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
1.74
± 0.17
Celecoxib 100 mg / Placebo
1.67
± 0.25
Celecoxib 100mg / 50mg
1.51
± 0.25
Placebo
1.08
± 0.18
11 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
1.67
± 0.18
Celecoxib 100 mg / Placebo
1.58
± 0.25
Celecoxib 100mg / 50mg
1.60
± 0.25
Placebo
1.10
± 0.18
12 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
1.56
± 0.18
Celecoxib 100 mg / Placebo
1.42
± 0.25
Celecoxib 100mg / 50mg
1.53
± 0.25
Placebo
1.07
± 0.18
24 hours
Group
Value
95% CI
Celecoxib 50mg/50mg
1.69
± 0.19
Celecoxib 100 mg / Placebo
1.62
± 0.27
Celecoxib 100mg / 50mg
1.60
± 0.27
Placebo
1.31
± 0.19
Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 6 Hours Post-First DoseSecondary· at 6 hours
Subjects Achieving at Least 'Moderate Relief' as Measured by STRRS (range: 0=no relief to 6=complete relief); Moderate relief is defined as STRRS = 3).
Subjects Achieving at Least 'Moderate Relief' as Measured by STRRS (range: 0=no relief to 6=complete relief); Moderate relief is defined as STRRS = 3).
Group
Value
95% CI
Celecoxib 50mg/50mg
21
Celecoxib 100 mg / Placebo
13
Celecoxib 100mg / 50mg
12
Placebo
14
Time to Perceptible Pain ReliefSecondary· Within 2 Hours Post-First Dose
Defined as time (measured by stopwatch) when subject began to feel any pain relieving effect from the drug
Group
Value
95% CI
Celecoxib 50mg/50mg
49
45 – 61
Celecoxib 100 mg (Pooled)
61
46 – 75
Placebo
97
62 – 120
Time to Meaningful Pain ReliefSecondary· Within 2 Hours Post-First Dose
The time (measured by stopwatch) when the subject felt their pain relief was meaningful to them was not estimable thus the number of subjects experiencing meaningful pain relief within 2 hours of first dose is reported
Group
Value
95% CI
Celecoxib 50mg/50mg
36
NA – NA
Celecoxib 100 mg (Pooled)
33
NA – NA
Placebo
15
NA – NA
Time to Onset of AnalgesiaSecondary· Within 2 Hours Post-First Dose
Equal to time of perceptible pain relief when both perceptible pain relief and meaningful pain relief were experienced- the median time was not estimable thus the number of subjects with onset of analgesia within 2 hours of first dose is reported
Group
Value
95% CI
Celecoxib 50mg/50mg
36
NA – NA
Celecoxib 100 mg (Pooled)
34
NA – NA
Placebo
15
NA – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days).
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
We are proposing a study in which we utilize and augment the sore throat pain model to assess the analgesic effectiveness of celecoxib compared to placebo in patients with painful pharyngitis under randomized, double-blind, placebo-controlled conditions.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Last refreshed: 3 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00402987.