Trial Outcomes & Findings for Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat (NCT NCT00402987)

NCT ID: NCT00402987

Last Updated: 2021-03-03

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 269 participants
• Primary outcome timeframe: 2 hours Post-First Dose
• Results posted on: 2021-03-03

Participant Flow

1 center in the United States.

Participant milestones

Measure	Celecoxib 50mg/50mg Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg	Celecoxib 100mg/Placebo Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo	Celecoxib 100mg/50mg Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg	Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Overall Study STARTED	90	45	45	89
Overall Study COMPLETED	90	45	44	89
Overall Study NOT COMPLETED	0	0	1	0

Reasons for withdrawal

Measure	Celecoxib 50mg/50mg Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg	Celecoxib 100mg/Placebo Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo	Celecoxib 100mg/50mg Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg	Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Overall Study Lack of Efficacy	0	0	1	0

Baseline Characteristics

Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat

Baseline characteristics by cohort

Measure	Celecoxib 50mg/50mg n=90 Participants Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg	Celecoxib 100mg/Placebo n=45 Participants Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo	Celecoxib 100mg/50mg n=45 Participants Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Total n=269 Participants Total of all reporting groups
Age, Continuous	19.5 years STANDARD_DEVIATION 1.3 • n=5 Participants	19.6 years STANDARD_DEVIATION 1.4 • n=7 Participants	19.9 years STANDARD_DEVIATION 2.3 • n=5 Participants	19.3 years STANDARD_DEVIATION 1.4 • n=4 Participants	19.5 years STANDARD_DEVIATION 1.5 • n=21 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	25 Participants n=7 Participants	15 Participants n=5 Participants	49 Participants n=4 Participants	144 Participants n=21 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	20 Participants n=7 Participants	30 Participants n=5 Participants	40 Participants n=4 Participants	125 Participants n=21 Participants

PRIMARY outcome

Timeframe: 2 hours Post-First Dose

Population: Modified intent-to-treat (MITT) population, defined as all subjects randomized to treatment who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment. The celecoxib 100mg (pooled) treatment group and placebo were compared for the primary endpoint. Celecoxib 50mg/50mg group was not in this analysis.

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.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose	21.0 units on a scale * hours Standard Error 2.20	9.4 units on a scale * hours Standard Error 2.21	—	—

SECONDARY outcome

Timeframe: Within First 6 hours Post-First Dose

Population: Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo. MITT population

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.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=90 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose 15 min	1.62 units on a scale Standard Error 0.64	1.92 units on a scale Standard Error 0.64	0.40 units on a scale Standard Error 0.64	—
Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose 30 min	4.70 units on a scale Standard Error 0.90	4.93 units on a scale Standard Error 0.90	2.14 units on a scale Standard Error 0.91	—
Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose 45 min	9.57 units on a scale Standard Error 1.22	7.05 units on a scale Standard Error 1.23	3.85 units on a scale Standard Error 1.24	—
Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose 60 min	12.18 units on a scale Standard Error 1.47	11.43 units on a scale Standard Error 1.47	5.34 units on a scale Standard Error 1.48	—
Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose 75 min	17.24 units on a scale Standard Error 1.62	13.24 units on a scale Standard Error 1.62	6.60 units on a scale Standard Error 1.64	—
Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose 90 min	22.39 units on a scale Standard Error 1.88	17.00 units on a scale Standard Error 1.88	6.75 units on a scale Standard Error 1.90	—
Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose 1.75 hours	24.68 units on a scale Standard Error 1.99	18.80 units on a scale Standard Error 1.99	7.41 units on a scale Standard Error 2.01	—
Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose 2 hours	26.63 units on a scale Standard Error 2.19	21.51 units on a scale Standard Error 2.19	8.06 units on a scale Standard Error 2.21	—
Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose 3 hours	27.90 units on a scale Standard Error 2.29	22.21 units on a scale Standard Error 2.29	9.06 units on a scale Standard Error 2.31	—
Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose 4 hours	25.52 units on a scale Standard Error 2.31	23.15 units on a scale Standard Error 2.31	10.35 units on a scale Standard Error 2.33	—
Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose 5 hours	24.12 units on a scale Standard Error 2.26	23.56 units on a scale Standard Error 2.26	10.47 units on a scale Standard Error 2.28	—
Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose 6 hours	21.42 units on a scale Standard Error 2.24	20.59 units on a scale Standard Error 2.24	9.04 units on a scale Standard Error 2.26	—

SECONDARY outcome

Timeframe: 7 to 24 hours

Population: Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo. MITT population

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.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=85 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=43 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=44 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=82 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose 7 hours	20.82 units on a scale Standard Error 2.30	22.01 units on a scale Standard Error 3.26	18.34 units on a scale Standard Error 3.25	9.32 units on a scale Standard Error 2.33
Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose 8 hours	20.39 units on a scale Standard Error 2.29	20.81 units on a scale Standard Error 3.24	19.93 units on a scale Standard Error 3.23	8.12 units on a scale Standard Error 2.31
Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose 9 hours	21.39 units on a scale Standard Error 2.36	19.18 units on a scale Standard Error 3.35	18.87 units on a scale Standard Error 3.33	9.92 units on a scale Standard Error 2.38
Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose 10 hours	21.26 units on a scale Standard Error 2.40	18.02 units on a scale Standard Error 3.40	18.06 units on a scale Standard Error 3.39	9.56 units on a scale Standard Error 2.42
Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose 11 hours	19.65 units on a scale Standard Error 2.40	17.43 units on a scale Standard Error 3.40	18.99 units on a scale Standard Error 3.39	9.29 units on a scale Standard Error 2.43
Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose 12 hours	19.01 units on a scale Standard Error 2.50	15.01 units on a scale Standard Error 3.54	20.22 units on a scale Standard Error 3.52	8.60 units on a scale Standard Error 2.52
Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose 24 hours	18.43 units on a scale Standard Error 2.58	16.50 units on a scale Standard Error 3.66	19.44 units on a scale Standard Error 3.65	12.81 units on a scale Standard Error 2.61

SECONDARY outcome

Timeframe: up to 6 hours

Population: Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo. MITT population

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.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=90 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose 15 min	0.2 units on a scale * hours Standard Error 0.1	0.2 units on a scale * hours Standard Error 0.1	0.1 units on a scale * hours Standard Error 0.1	—
Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose 30 min	1.0 units on a scale * hours Standard Error 0.2	1.1 units on a scale * hours Standard Error 0.2	0.4 units on a scale * hours Standard Error 0.2	—
Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose 45 min	2.8 units on a scale * hours Standard Error 0.4	2.6 units on a scale * hours Standard Error 0.4	1.1 units on a scale * hours Standard Error 0.5	—
Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose 60 min	5.5 units on a scale * hours Standard Error 0.7	4.9 units on a scale * hours Standard Error 0.7	2.3 units on a scale * hours Standard Error 0.7	—
Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose 75 min	9.2 units on a scale * hours Standard Error 1.0	8.0 units on a scale * hours Standard Error 1.0	3.8 units on a scale * hours Standard Error 1.0	—
Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose 90 min	14.1 units on a scale * hours Standard Error 1.4	11.8 units on a scale * hours Standard Error 1.4	5.4 units on a scale * hours Standard Error 1.4	—
Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose 1.75 hours	20.0 units on a scale * hours Standard Error 1.8	16.2 units on a scale * hours Standard Error 1.8	7.2 units on a scale * hours Standard Error 1.8	—
Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose 2 hours	26.4 units on a scale * hours Standard Error 2.3	21.3 units on a scale * hours Standard Error 2.3	9.1 units on a scale * hours Standard Error 2.3	—
Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose 3 hours	53.7 units on a scale * hours Standard Error 4.3	43.1 units on a scale * hours Standard Error 4.3	17.7 units on a scale * hours Standard Error 4.4	—
Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose 4 hours	80.4 units on a scale * hours Standard Error 6.5	65.8 units on a scale * hours Standard Error 6.5	27.4 units on a scale * hours Standard Error 6.5	—
Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose 5 hours	105.2 units on a scale * hours Standard Error 8.5	89.2 units on a scale * hours Standard Error 8.5	37.8 units on a scale * hours Standard Error 8.6	—
Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose 6 hours	128.0 units on a scale * hours Standard Error 10.5	111.2 units on a scale * hours Standard Error 10.5	47.6 units on a scale * hours Standard Error 10.6	—

SECONDARY outcome

Timeframe: 7 to 24 hours

Population: Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo. MITT population

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.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=85 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=43 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=44 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=82 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose 8 hours	169.8 units on a scale * hours Standard Error 14.3	173.2 units on a scale * hours Standard Error 20.3	130.8 units on a scale * hours Standard Error 20.2	65.4 units on a scale * hours Standard Error 14.5
Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose 9 hours	190.7 units on a scale * hours Standard Error 16.3	193.2 units on a scale * hours Standard Error 23.1	150.2 units on a scale * hours Standard Error 23.0	74.4 units on a scale * hours Standard Error 16.5
Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose 11 hours	232.4 units on a scale * hours Standard Error 20.2	229.5 units on a scale * hours Standard Error 28.7	187.2 units on a scale * hours Standard Error 28.6	93.5 units on a scale * hours Standard Error 20.5
Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose 7 hours	149.2 units on a scale * hours Standard Error 12.4	151.8 units on a scale * hours Standard Error 17.5	111.6 units on a scale * hours Standard Error 17.5	56.6 units on a scale * hours Standard Error 12.5
Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose 10 hours	212.0 units on a scale * hours Standard Error 18.2	211.8 units on a scale * hours Standard Error 25.9	168.6 units on a scale * hours Standard Error 25.8	84.1 units on a scale * hours Standard Error 18.4
Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose 12 hours	251.8 units on a scale * hours Standard Error 22.3	245.7 units on a scale * hours Standard Error 31.6	206.8 units on a scale * hours Standard Error 31.5	102.5 units on a scale * hours Standard Error 22.5
Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose 24 hours	476.4 units on a scale * hours Standard Error 48.7	434.8 units on a scale * hours Standard Error 69.0	444.7 units on a scale * hours Standard Error 68.8	231.0 units on a scale * hours Standard Error 49.2

SECONDARY outcome

Timeframe: within the first 6 hours

Population: Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo. MITT population

STRRS score (scale: 0 no relief to 6 complete relief); a higher pain score indicated a greater reduction in pain.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=90 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose 15 min	0.12 scores on a scale Standard Error 0.04	0.09 scores on a scale Standard Error 0.04	0.16 scores on a scale Standard Error 0.04	—
Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose 30 min	0.41 scores on a scale Standard Error 0.07	0.34 scores on a scale Standard Error 0.07	0.34 scores on a scale Standard Error 0.07	—
Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose 45 min	0.74 scores on a scale Standard Error 0.09	0.69 scores on a scale Standard Error 0.09	0.52 scores on a scale Standard Error 0.09	—
Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose 60 min	1.22 scores on a scale Standard Error 0.12	1.01 scores on a scale Standard Error 0.12	0.64 scores on a scale Standard Error 0.12	—
Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose 75 min	1.58 scores on a scale Standard Error 0.13	1.27 scores on a scale Standard Error 0.13	0.79 scores on a scale Standard Error 0.14	—
Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose 90 min	1.88 scores on a scale Standard Error 0.15	1.61 scores on a scale Standard Error 0.15	0.88 scores on a scale Standard Error 0.15	—
Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose 1.75 hours	2.10 scores on a scale Standard Error 0.16	1.74 scores on a scale Standard Error 0.16	0.93 scores on a scale Standard Error 0.16	—
Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose 2 hours	2.22 scores on a scale Standard Error 0.17	1.93 scores on a scale Standard Error 0.17	0.92 scores on a scale Standard Error 0.17	—
Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose 3 hours	2.13 scores on a scale Standard Error 0.17	1.92 scores on a scale Standard Error 0.17	0.92 scores on a scale Standard Error 0.17	—
Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose 4 hours	2.08 scores on a scale Standard Error 0.17	1.96 scores on a scale Standard Error 0.17	1.10 scores on a scale Standard Error 0.17	—
Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose 5 hours	2.00 scores on a scale Standard Error 0.17	1.97 scores on a scale Standard Error 0.17	1.07 scores on a scale Standard Error 0.17	—
Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose 6 hours	1.81 scores on a scale Standard Error 0.17	1.86 scores on a scale Standard Error 0.17	0.96 scores on a scale Standard Error 0.17	—

SECONDARY outcome

Timeframe: 7 to 24 hours

Population: Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo. MITT population

STRRS score (scale: 0 no relief to 6 complete relief); a higher score indicated a greater reduction in pain.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=85 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=43 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=44 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=82 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose 10 hours	1.74 scores on a scale Standard Error 0.17	1.67 scores on a scale Standard Error 0.25	1.51 scores on a scale Standard Error 0.25	1.08 scores on a scale Standard Error 0.18
Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose 11 hours	1.67 scores on a scale Standard Error 0.18	1.58 scores on a scale Standard Error 0.25	1.60 scores on a scale Standard Error 0.25	1.10 scores on a scale Standard Error 0.18
Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose 12 hours	1.56 scores on a scale Standard Error 0.18	1.42 scores on a scale Standard Error 0.25	1.53 scores on a scale Standard Error 0.25	1.07 scores on a scale Standard Error 0.18
Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose 24 hours	1.69 scores on a scale Standard Error 0.19	1.62 scores on a scale Standard Error 0.27	1.60 scores on a scale Standard Error 0.27	1.31 scores on a scale Standard Error 0.19
Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose 7 hours	1.71 scores on a scale Standard Error 0.17	2.00 scores on a scale Standard Error 0.24	1.67 scores on a scale Standard Error 0.24	0.93 scores on a scale Standard Error 0.17
Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose 8 hours	1.68 scores on a scale Standard Error 0.17	1.80 scores on a scale Standard Error 0.24	1.71 scores on a scale Standard Error 0.24	0.97 scores on a scale Standard Error 0.17
Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose 9 hours	1.69 scores on a scale Standard Error 0.17	1.76 scores on a scale Standard Error 0.25	1.56 scores on a scale Standard Error 0.25	1.08 scores on a scale Standard Error 0.17

SECONDARY outcome

Timeframe: at 6 hours

Population: MITT population

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).

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=90 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 6 Hours Post-First Dose	28 subjects	31 subjects	13 subjects	—

SECONDARY outcome

Timeframe: 12 hours

Population: MITT population

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).

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=45 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=45 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 12 Hours Post-First Dose	21 subjects	13 subjects	12 subjects	14 subjects

SECONDARY outcome

Timeframe: Within 2 Hours Post-First Dose

Population: MITT population. Number of Subjects achieving perceptible pain relief: 77 for celecoxib 50mg/50mg; 67 for celecoxib 100mg (pooled); 46 for placebo Upper 95% CI for placebo group was \>120

Defined as time (measured by stopwatch) when subject began to feel any pain relieving effect from the drug

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=90 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Time to Perceptible Pain Relief	49 minutes Interval 45.0 to 61.0	61 minutes Interval 46.0 to 75.0	97 minutes Interval 62.0 to 120.0	—

SECONDARY outcome

Timeframe: Within 2 Hours Post-First Dose

Population: MITT population. The median time to meaningful pain relief, including all subjects, was \>2 hours in each group (time was censored at 2 hours) Median time and CI were not estimable

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

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=90 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Time to Meaningful Pain Relief	36 subjects	33 subjects	15 subjects	—

SECONDARY outcome

Timeframe: Within 2 Hours Post-First Dose

Population: MITT population. The median time to onset of analgesia, including all subjects, was \>2 hours in each group (time was censored at 2 hours). Median time and CI were not estimable.

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

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=90 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Time to Onset of Analgesia	36 subjects	34 subjects	15 subjects	—

SECONDARY outcome

Timeframe: 6 Hours Post-First Dose

Population: MITT population

Subject assessment of overall impression of study drug on 4 point scale from 1 (poor) to 4 (excellent)

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=89 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose Poor (1)	35 subjects	33 subjects	60 subjects	—
Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose Excellent (4)	5 subjects	4 subjects	2 subjects	—
Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose Good (3)	24 subjects	25 subjects	5 subjects	—
Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose Fair (2)	25 subjects	27 subjects	22 subjects	—

SECONDARY outcome

Timeframe: 12 and 24 hours Post-First Dose

Population: Subjects analyzed at 24 hours were different for 2 groups: Celecoxib 100mg/Placebo=45 and Placebo=87. MITT population

Subject assessment of overall impression of study drug on 4 point scale from 1 (poor) to 4 (excellent)

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=89 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=44 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=44 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=85 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose Excellent (4) - 12 hours	8 subjects	5 subjects	0 subjects	1 subjects
Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose Good (3) - 12 hours	23 subjects	10 subjects	13 subjects	10 subjects
Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose Fair (2) - 12 hours	21 subjects	11 subjects	11 subjects	18 subjects
Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose Poor (1) - 12 hours	37 subjects	18 subjects	20 subjects	56 subjects
Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose Fair (2) - 24 hours	25 subjects	7 subjects	15 subjects	15 subjects
Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose Poor (1) - 24 hours	37 subjects	21 subjects	18 subjects	57 subjects
Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose Excellent (4) - 24 hours	7 subjects	4 subjects	2 subjects	2 subjects
Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose Good (3) - 24 hours	20 subjects	13 subjects	9 subjects	13 subjects

OTHER_PRE_SPECIFIED outcome

Timeframe: Within first 6 hours post-first dose

Population: Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo. MITT population

The Pain Intensity Difference (PID) based on TSS (scale: 0=not sore to 10=very sore) was calculated as the difference between the pain intensity at the time and at baseline.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=90 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose 15 min	0.06 scores on a scale Standard Error 0.04	0.06 scores on a scale Standard Error 0.04	0.06 scores on a scale Standard Error 0.04	—
Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose 30 min	0.39 scores on a scale Standard Error 0.08	0.36 scores on a scale Standard Error 0.08	0.29 scores on a scale Standard Error 0.08	—
Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose 45 min	0.74 scores on a scale Standard Error 0.10	0.66 scores on a scale Standard Error 0.10	0.43 scores on a scale Standard Error 0.10	—
Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose 60 min	1.17 scores on a scale Standard Error 0.13	0.97 scores on a scale Standard Error 0.13	0.60 scores on a scale Standard Error 0.13	—
Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose 75 min	1.62 scores on a scale Standard Error 0.15	1.29 scores on a scale Standard Error 0.15	0.75 scores on a scale Standard Error 0.15	—
Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose 90 min	1.97 scores on a scale Standard Error 0.17	1.64 scores on a scale Standard Error 0.17	0.76 scores on a scale Standard Error 0.17	—
Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose 1.75 hours	2.24 scores on a scale Standard Error 0.18	1.86 scores on a scale Standard Error 0.18	0.79 scores on a scale Standard Error 0.19	—
Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose 2 hours	2.39 scores on a scale Standard Error 0.19	2.03 scores on a scale Standard Error 0.19	0.78 scores on a scale Standard Error 0.19	—
Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose 3 hours	2.43 scores on a scale Standard Error 0.20	2.09 scores on a scale Standard Error 0.20	0.85 scores on a scale Standard Error 0.21	—
Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose 4 hours	2.14 scores on a scale Standard Error 0.21	2.12 scores on a scale Standard Error 0.21	1.01 scores on a scale Standard Error 0.21	—
Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose 5 hours	2.03 scores on a scale Standard Error 0.20	2.06 scores on a scale Standard Error 0.21	1.04 scores on a scale Standard Error 0.21	—
Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose 6 hours	1.83 scores on a scale Standard Error 0.20	1.90 scores on a scale Standard Error 0.20	0.90 scores on a scale Standard Error 0.21	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 to 24 hours post-first dose

Population: Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo. MITT population

The Pain Intensity Difference (PID) based on TSS (scale: 0=not sore to 10=very sore) was calculated as the difference between the pain intensity at the time and at baseline.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=85 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=43 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=44 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=82 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose 7 hours	1.65 scores on a scale Standard Error 0.21	1.95 scores on a scale Standard Error 0.30	1.68 scores on a scale Standard Error 0.29	0.78 scores on a scale Standard Error 0.21
Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose 8 hours	1.67 scores on a scale Standard Error 0.21	1.65 scores on a scale Standard Error 0.30	1.70 scores on a scale Standard Error 0.30	0.76 scores on a scale Standard Error 0.22
Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose 9 hours	1.76 scores on a scale Standard Error 0.22	1.60 scores on a scale Standard Error 0.32	1.65 scores on a scale Standard Error 0.32	0.90 scores on a scale Standard Error 0.23
Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose 10 hours	1.80 scores on a scale Standard Error 0.23	1.58 scores on a scale Standard Error 0.33	1.63 scores on a scale Standard Error 0.32	0.87 scores on a scale Standard Error 0.23
Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose 11 hours	1.76 scores on a scale Standard Error 0.23	1.53 scores on a scale Standard Error 0.32	1.76 scores on a scale Standard Error 0.32	0.87 scores on a scale Standard Error 0.23
Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose 12 hours	1.53 scores on a scale Standard Error 0.23	1.37 scores on a scale Standard Error 0.33	1.80 scores on a scale Standard Error 0.33	0.82 scores on a scale Standard Error 0.24
Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose 24 hours	1.62 scores on a scale Standard Error 0.25	1.46 scores on a scale Standard Error 0.36	1.78 scores on a scale Standard Error 0.35	1.17 scores on a scale Standard Error 0.25

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 hour period Post-First Dose

Population: MITT population

SPID2 was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Sore Throat PID was calculated as the difference between the pain intensity (TSS scale: 0=not sore to 10=very sore) at 2 hours post dose and at baseline.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=90 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Sore Throat Pain Intensity Difference (SPID2) as Measured by Throat Soreness Scale (TSS) at 2 Hours Post-First Dose	2.4 units on a scale * hours Standard Error 0.21	2.0 units on a scale * hours Standard Error 0.21	1.0 units on a scale * hours Standard Error 0.21	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 6 hours Post-First Dose

Population: Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo. MITT population At 15min the SE was \<0.01 for all 3 groups

The sum of sore throat pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Sore Throat PID was calculated as the difference between the pain intensity (TSS range: 0=not sore to 10=very sore) at the time and at baseline.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=90 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose 3 hours	4.76 units on a scale * hours Standard Error 0.39	4.02 units on a scale * hours Standard Error 0.39	1.83 units on a scale * hours Standard Error 0.39	—
Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose 15 min	0.01 units on a scale * hours Standard Error 0.01	0.01 units on a scale * hours Standard Error 0.01	0.01 units on a scale * hours Standard Error 0.01	—
Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose 30 min	0.07 units on a scale * hours Standard Error 0.02	0.06 units on a scale * hours Standard Error 0.02	0.05 units on a scale * hours Standard Error 0.02	—
Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose 45 min	0.21 units on a scale * hours Standard Error 0.03	0.19 units on a scale * hours Standard Error 0.03	0.14 units on a scale * hours Standard Error 0.04	—
Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose 60 min	0.45 units on a scale * hours Standard Error 0.06	0.39 units on a scale * hours Standard Error 0.06	0.27 units on a scale * hours Standard Error 0.06	—
Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose 75 min	0.80 units on a scale * hours Standard Error 0.09	0.67 units on a scale * hours Standard Error 0.09	0.44 units on a scale * hours Standard Error 0.09	—
Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose 90 min	1.24 units on a scale * hours Standard Error 0.13	1.04 units on a scale * hours Standard Error 0.13	0.63 units on a scale * hours Standard Error 0.13	—
Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose 1.75 hours	1.77 units on a scale * hours Standard Error 0.16	1.48 units on a scale * hours Standard Error 0.16	0.82 units on a scale * hours Standard Error 0.17	—
Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose 2 hours	2.35 units on a scale * hours Standard Error 0.21	1.96 units on a scale * hours Standard Error 0.21	1.02 units on a scale * hours Standard Error 0.21	—
Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose 4 hours	7.05 units on a scale * hours Standard Error 0.58	6.12 units on a scale * hours Standard Error 0.58	2.76 units on a scale * hours Standard Error 0.59	—
Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose 5 hours	9.13 units on a scale * hours Standard Error 0.76	8.21 units on a scale * hours Standard Error 0.77	3.79 units on a scale * hours Standard Error 0.77	—
Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose 6 hours	11.07 units on a scale * hours Standard Error 0.94	10.20 units on a scale * hours Standard Error 0.94	4.75 units on a scale * hours Standard Error 0.95	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 to 24 hours Post-First Dose

Population: Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo. MITT population

The sum of sore throat pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Sore Throat PID was calculated as the difference between the pain intensity (TSS range: 0=not sore to 10=very sore) at the time and at baseline.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=85 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=43 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=44 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=82 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose 7 hours	12.8 units on a scale * hours Standard Error 1.1	14.2 units on a scale * hours Standard Error 1.6	9.9 units on a scale * hours Standard Error 1.6	5.6 units on a scale * hours Standard Error 1.1
Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose 8 hours	14.5 units on a scale * hours Standard Error 1.3	16.0 units on a scale * hours Standard Error 1.8	11.6 units on a scale * hours Standard Error 1.8	6.3 units on a scale * hours Standard Error 1.3
Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose 9 hours	16.2 units on a scale * hours Standard Error 1.5	17.7 units on a scale * hours Standard Error 2.1	13.3 units on a scale * hours Standard Error 2.1	7.2 units on a scale * hours Standard Error 1.5
Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose 10 hours	18.0 units on a scale * hours Standard Error 1.7	19.3 units on a scale * hours Standard Error 2.4	14.9 units on a scale * hours Standard Error 2.3	8.1 units on a scale * hours Standard Error 1.7
Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose 11 hours	19.7 units on a scale * hours Standard Error 1.8	20.8 units on a scale * hours Standard Error 2.6	16.6 units on a scale * hours Standard Error 2.6	8.9 units on a scale * hours Standard Error 1.9
Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose 12 hours	21.4 units on a scale * hours Standard Error 2.0	22.3 units on a scale * hours Standard Error 2.9	18.4 units on a scale * hours Standard Error 2.9	9.8 units on a scale * hours Standard Error 2.1
Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose 24 hours	40.3 units on a scale * hours Standard Error 4.5	39.2 units on a scale * hours Standard Error 6.4	39.8 units on a scale * hours Standard Error 6.4	21.7 units on a scale * hours Standard Error 4.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 6 hours Post-First Dose

Population: Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo. MITT population

The Difficulty Swallowing Pain Intensity Difference (PID) was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=90 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose 30 min	4.85 units on a scale Standard Error 1.21	3.14 units on a scale Standard Error 1.21	1.11 units on a scale Standard Error 1.21	—
Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose 15 min	1.69 units on a scale Standard Error 0.89	1.16 units on a scale Standard Error 0.89	0.81 units on a scale Standard Error 0.89	—
Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose 45 min	6.99 units on a scale Standard Error 1.43	5.75 units on a scale Standard Error 1.43	2.85 units on a scale Standard Error 1.44	—
Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose 60 min	11.21 units on a scale Standard Error 1.65	8.02 units on a scale Standard Error 1.65	3.53 units on a scale Standard Error 1.66	—
Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose 75 min	14.31 units on a scale Standard Error 1.84	10.47 units on a scale Standard Error 1.84	3.95 units on a scale Standard Error 1.85	—
Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose 90 min	17.40 units on a scale Standard Error 1.99	12.21 units on a scale Standard Error 1.99	3.97 units on a scale Standard Error 2.00	—
Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose 1.75 hours	20.52 units on a scale Standard Error 2.11	15.15 units on a scale Standard Error 2.11	4.45 units on a scale Standard Error 2.12	—
Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose 2 hours	21.76 units on a scale Standard Error 2.25	16.50 units on a scale Standard Error 2.25	4.99 units on a scale Standard Error 2.26	—
Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose 3 hours	22.20 units on a scale Standard Error 2.17	18.39 units on a scale Standard Error 2.17	4.20 units on a scale Standard Error 2.18	—
Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose 4 hours	20.53 units on a scale Standard Error 2.33	18.27 units on a scale Standard Error 2.33	7.28 units on a scale Standard Error 2.34	—
Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose 5 hours	18.40 units on a scale Standard Error 2.31	18.11 units on a scale Standard Error 2.31	6.02 units on a scale Standard Error 2.32	—
Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose 6 hours	16.62 units on a scale Standard Error 2.27	16.43 units on a scale Standard Error 2.27	5.70 units on a scale Standard Error 2.29	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 to 24 hours Post-First Dose

Population: Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo. MITT population

The Difficulty Swallowing Pain Intensity Difference (PID) was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=85 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=43 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=44 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=82 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose 7 hours	16.91 units on a scale Standard Error 2.35	18.11 units on a scale Standard Error 3.32	11.38 units on a scale Standard Error 3.32	4.86 units on a scale Standard Error 2.36
Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose 8 hours	16.53 units on a scale Standard Error 2.38	17.29 units on a scale Standard Error 3.37	13.40 units on a scale Standard Error 3.37	4.88 units on a scale Standard Error 2.39
Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose 9 hours	16.59 units on a scale Standard Error 2.35	15.10 units on a scale Standard Error 3.32	12.68 units on a scale Standard Error 3.32	5.46 units on a scale Standard Error 2.36
Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose 10 hours	16.61 units on a scale Standard Error 2.39	14.32 units on a scale Standard Error 3.38	11.68 units on a scale Standard Error 3.38	5.85 units on a scale Standard Error 2.41
Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose 11 hours	15.01 units on a scale Standard Error 2.45	12.99 units on a scale Standard Error 3.46	13.13 units on a scale Standard Error 3.46	5.22 units on a scale Standard Error 2.46
Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose 12 hours	15.40 units on a scale Standard Error 2.51	11.44 units on a scale Standard Error 3.55	13.41 units on a scale Standard Error 3.55	5.30 units on a scale Standard Error 2.53
Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose 24 hours	14.25 units on a scale Standard Error 2.70	13.67 units on a scale Standard Error 3.83	13.24 units on a scale Standard Error 3.82	8.79 units on a scale Standard Error 2.72

OTHER_PRE_SPECIFIED outcome

Timeframe: Over 2 hour Period Post-First Dose

Population: MITT population

SPID2 was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS scale: 0mm=not difficult, 100mm=very difficult) at 2 hours post dose and at baseline.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=90 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Sum of Sore Throat Pain Intensity Difference (SPID2) as Measured by Difficulty Swallowing Scale (DSS) at 2 Hours Post-First Dose	22.0 units on a scale * hours Standard Error 2.73	16.0 units on a scale * hours Standard Error 2.73	5.8 units on a scale * hours Standard Error 2.75	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 6 hours Post-First Dose

Population: Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo. MITT population

The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=90 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose 45 min	2.5 units on a scale * hours Standard Error 0.6	1.8 units on a scale * hours Standard Error 0.6	0.8 units on a scale * hours Standard Error 0.6	—
Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose 15 min	0.2 units on a scale * hours Standard Error 0.1	0.1 units on a scale * hours Standard Error 0.1	0.1 units on a scale * hours Standard Error 0.1	—
Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose 30 min	1.0 units on a scale * hours Standard Error 0.3	0.7 units on a scale * hours Standard Error 0.3	0.3 units on a scale * hours Standard Error 0.3	—
Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose 60 min	4.8 units on a scale * hours Standard Error 1.0	3.5 units on a scale * hours Standard Error 1.0	1.6 units on a scale * hours Standard Error 1.0	—
Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose 75 min	8.0 units on a scale * hours Standard Error 1.4	5.8 units on a scale * hours Standard Error 1.4	2.6 units on a scale * hours Standard Error 1.4	—
Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose 90 min	11.9 units on a scale * hours Standard Error 1.8	8.7 units on a scale * hours Standard Error 1.8	3.6 units on a scale * hours Standard Error 1.8	—
Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose 1.75 hours	16.7 units on a scale * hours Standard Error 2.2	12.1 units on a scale * hours Standard Error 2.2	4.6 units on a scale * hours Standard Error 2.3	—
Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose 2 hours	22.0 units on a scale * hours Standard Error 2.7	16.0 units on a scale * hours Standard Error 2.7	5.8 units on a scale * hours Standard Error 2.8	—
Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose 3 hours	43.9 units on a scale * hours Standard Error 4.8	33.5 units on a scale * hours Standard Error 4.8	10.4 units on a scale * hours Standard Error 4.8	—
Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose 4 hours	65.3 units on a scale * hours Standard Error 6.8	51.8 units on a scale * hours Standard Error 6.8	16.1 units on a scale * hours Standard Error 6.9	—
Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose 5 hours	84.8 units on a scale * hours Standard Error 9.0	70.0 units on a scale * hours Standard Error 9.0	22.8 units on a scale * hours Standard Error 9.0	—
Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose 6 hours	102.3 units on a scale * hours Standard Error 11.0	87.3 units on a scale * hours Standard Error 11.0	28.6 units on a scale * hours Standard Error 11.1	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 to 24 hours Post-First Dose

Population: Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo. MITT population

The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=85 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=43 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=44 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=82 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose 7 hours	119.1 units on a scale * hours Standard Error 13.0	133.6 units on a scale * hours Standard Error 18.3	72.2 units on a scale * hours Standard Error 18.3	33.9 units on a scale * hours Standard Error 13.0
Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose 8 hours	135.8 units on a scale * hours Standard Error 15.0	151.3 units on a scale * hours Standard Error 21.3	84.5 units on a scale * hours Standard Error 21.3	38.8 units on a scale * hours Standard Error 15.1
Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose 9 hours	152.3 units on a scale * hours Standard Error 17.1	167.5 units on a scale * hours Standard Error 24.2	97.6 units on a scale * hours Standard Error 24.2	43.9 units on a scale * hours Standard Error 17.2
Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose 10 hours	168.9 units on a scale * hours Standard Error 19.1	182.2 units on a scale * hours Standard Error 27.0	109.8 units on a scale * hours Standard Error 27.0	49.6 units on a scale * hours Standard Error 19.2
Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose 11 hours	184.7 units on a scale * hours Standard Error 21.1	195.8 units on a scale * hours Standard Error 29.9	122.2 units on a scale * hours Standard Error 29.9	55.1 units on a scale * hours Standard Error 21.3
Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose 12 hours	200.0 units on a scale * hours Standard Error 23.2	208.0 units on a scale * hours Standard Error 32.8	135.4 units on a scale * hours Standard Error 32.8	60.4 units on a scale * hours Standard Error 23.4
Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose 24 hours	377.9 units on a scale * hours Standard Error 50.4	358.7 units on a scale * hours Standard Error 71.3	295.3 units on a scale * hours Standard Error 71.3	144.9 units on a scale * hours Standard Error 50.7

OTHER_PRE_SPECIFIED outcome

Timeframe: At 6 hours

Population: MITT population

Number of Subjects with >= 50% Pain Intensity Difference (PID) on the DSS. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS scale: 0mm=not difficult, 100mm=very difficult) at 6 hours and at baseline.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=90 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 6 Hours Post-First Dose	22 subjects	24 subjects	14 subjects	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At 12 Hours

Population: MITT population

Number of Subjects with >= 50% Pain Intensity Difference (PID) on the DSS. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS scale: 0mm=not difficult, 100mm=very difficult) at 12 hours and at baseline.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=45 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=45 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 12 Hours Post-First Dose	24 subjects	12 subjects	10 subjects	12 subjects

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 and 6 hours Post-First Dose

Population: Subjects evaluated at 6 hours: 85 for 50mg/50mg; 87 for 100mg (pooled); 85 for Placebo. MITT population

TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief).

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=90 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Total Pain Relief (TOTPAR) at 2 and 6 Hours Post-First Dose 2 hours	2.6 scores on a scale Standard Error 0.2	2.2 scores on a scale Standard Error 0.2	1.3 scores on a scale Standard Error 0.2	—
Total Pain Relief (TOTPAR) at 2 and 6 Hours Post-First Dose 6 hours	10.6 scores on a scale Standard Error 0.8	9.9 scores on a scale Standard Error 0.8	5.3 scores on a scale Standard Error 0.8	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 and 24 hours Post-First Dose

Population: Subjects evaluated at 24 hours: 84 for 50mg/50mg; 43 for 100mg/Placebo; 44 for 100mg/50mg; 81 for Placebo. MITT population

TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief).

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=81 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=40 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=43 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=75 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Total Pain Relief (TOTPAR) at 12 and 24 Hours Post-First Dose 12 hours	20.6 scores on a scale Standard Error 1.7	22.0 scores on a scale Standard Error 2.4	17.5 scores on a scale Standard Error 2.4	11.6 scores on a scale Standard Error 1.7
Total Pain Relief (TOTPAR) at 12 and 24 Hours Post-First Dose 24 hours	40.9 scores on a scale Standard Error 3.6	41.5 scores on a scale Standard Error 5.1	36.7 scores on a scale Standard Error 5.1	27.3 scores on a scale Standard Error 3.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 hours Post-First Dose

Population: MITT population

TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief). Maximum TOTPAR over 6 hours is 36. If the subject calculated TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject is said to have achieved >=50% TOTPAR.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=90 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Subjects With >= 50% Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose	18 subjects	19 subjects	7 subjects	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 hours Post-First Dose

Population: MITT population

TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief). Maximum TOTPAR over 12 hours is 72. If the subject calculated TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject is said to have achieved >=50% TOTPAR.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=45 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=45 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Subjects With >= 50% Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose	18 subjects	12 subjects	8 subjects	6 subjects

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 hours Post-First Dose

Population: MITT population

NNT is number of subjects needed to treat to have one extra subject report a 50% or better pain relief over 6 hours based on maximum possible pain relief on Sore Throat Relief Rating Scale. Maximum TOTPAR over 6 hours is 36. If the subject TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject has achieved >=50% TOTPAR.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=90 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose	18 subjects	19 subjects	7 subjects	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 hours Post-First Dose

Population: MITT population Comparison Celecoxib 100mg/50mg - Placebo: the NNT value was non-estimable

NNT is number of subjects needed to treat to have one subject report a 50% or better pain relief over 12 hours based on maximum possible pain relief on Sore Throat Relief Rating Scale. Maximum TOTPAR over 12 hours is 72. If the subject TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject has achieved >=50% TOTPAR.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=45 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=45 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose	18 subjects	12 subjects	8 subjects	6 subjects

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 and 6 hours Post-First Dose

Population: MITT population

>= 35% and 50% Pain Intensity Difference (PID) on the Pain Intensity-Visual Analog Scale (PI-VAS) (scale: 0mm=no pain, 100mm=worst possible pain). The PID was calculated as the difference between the pain intensity at the time and at baseline.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=90 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 2 and 6 Hours Post-First Dose 2 hours >=35% gone	39 subjects	32 subjects	15 subjects	—
Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 2 and 6 Hours Post-First Dose 6 hours >=35% gone	31 subjects	29 subjects	12 subjects	—
Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 2 and 6 Hours Post-First Dose 2 hours >=50% gone	28 subjects	24 subjects	8 subjects	—
Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 2 and 6 Hours Post-First Dose 6 hours >=50% gone	23 subjects	22 subjects	9 subjects	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 hours Post-First Dose

Population: MITT population

>= 35% and 50% Pain Intensity Difference (PID) on the Pain Intensity-Visual Analog Scale (PI-VAS) (scale: 0mm=no pain, 100mm=worst possible pain). The PID was calculated as the difference between the pain intensity at 12 hours and at baseline.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=45 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=45 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 12 Hours Post-First Dose 12 hours >=35% gone	30 subjects	13 subjects	12 subjects	13 subjects
Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 12 Hours Post-First Dose 12 hours >=50% gone	22 subjects	12 subjects	10 subjects	9 subjects

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 and 6 hours Post-First Dose

Population: MITT population

Symptom relief measured as self-directed endpoints defined by each individual at end of study using Sore Throat Relief Rating Scale (STRRS); STRRS score ranges from 0=no relief to 6=complete relief. If subject scored same or greater in their STRRS during the study then they achieved their 'Meaningful Relief' or 'Much Improvement'.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 2 and 6 Hours Post-First Dose meaningful relief - 2 hours- achieved	31 subjects	26 subjects	12 subjects	—
Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 2 and 6 Hours Post-First Dose meaningful relief- 2 hours- not achieved	59 subjects	63 subjects	77 subjects	—
Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 2 and 6 Hours Post-First Dose meaningful relief - 6 hours- achieved	40 subjects	38 subjects	17 subjects	—
Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 2 and 6 Hours Post-First Dose meaningful relief- 6 hours- not achieved	50 subjects	51 subjects	72 subjects	—
Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 2 and 6 Hours Post-First Dose much improvement - 2 hours- achieved	22 subjects	22 subjects	10 subjects	—
Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 2 and 6 Hours Post-First Dose much improvement - 2 hours- not achieved	68 subjects	67 subjects	79 subjects	—
Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 2 and 6 Hours Post-First Dose much improvement - 6 hours- achieved	33 subjects	31 subjects	12 subjects	—
Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 2 and 6 Hours Post-First Dose much improvement - 6 hours- not achieved	57 subjects	58 subjects	77 subjects	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 hours Post-First Dose

Population: MITT population

Symptom relief measured as self-directed endpoints defined by each individual at end of study using Sore Throat Relief Rating Scale (STRRS); STRRS score ranges from 0=no relief to 6=complete relief. If subject scored same or greater in their STRRS during the study then they achieved their 'Meaningful Relief' or 'Much Improvement'.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=45 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=44 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose Meaningful Relief - achieved	44 subjects	26 subjects	20 subjects	20 subjects
Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose Meaningful Relief - not achieved	46 subjects	19 subjects	24 subjects	69 subjects
Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose Much Improvement - achieved	38 subjects	22 subjects	12 subjects	16 subjects
Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose Much Improvement - not achieved	52 subjects	23 subjects	32 subjects	73 subjects

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 6 hours Post-First Dose

Population: MITT population

At end of study subjects defined meaningful pain relief by completing Meaningful Relief Scale. Meaningful relief was achieved if Sore Throat Relief Rating Scale (STRRS) score (range: 0=no relief to 6=complete relief) at end of the study was the same or higher than individually defined relief score during the study. Perceptible relief is STRRS >0.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Had Perceptible Relief Onset Time Within 1 Hour Achieved	31 subjects	27 subjects	12 subjects	—
Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Had Perceptible Relief Onset Time Within 1 Hour Not achieved	59 subjects	62 subjects	77 subjects	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 and 24 hours Post-First Dose

Population: MITT population

At end of study subjects defined meaningful pain relief by completing the Meaningful Relief Scale. Meaningful relief was achieved if Sore Throat Relief Rating Scale (STRRS)(range: 0=no relief to 6=complete relief) score at end of the study was the same or higher than individually defined relief score during the study. Perceptible relief is STRRS >0

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=45 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=44 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Still Had Perceptible Relief at 12 and 24 Hours Post-First Dose at 12 hours - Achieved	32 subjects	16 subjects	12 subjects	11 subjects
Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Still Had Perceptible Relief at 12 and 24 Hours Post-First Dose at 12 hours - Not Achieved	58 subjects	29 subjects	32 subjects	78 subjects
Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Still Had Perceptible Relief at 12 and 24 Hours Post-First Dose at 24 hours - Achieved	28 subjects	16 subjects	9 subjects	11 subjects
Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Still Had Perceptible Relief at 12 and 24 Hours Post-First Dose at 24 hours - Not Achieved	62 subjects	29 subjects	35 subjects	78 subjects

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Hours

Population: Number of subjects who achieved meaningful relief within 6 hours

Perceptible Relief is score >0 on STRRS. Individual level of meaningful relief had to be reached within 6 hours. Meaningful Relief was achieved if Sore Throat Relief Rating Scale (STRRS)(range: 0=no relief to 6=complete relief)score at the end of the study was the same or higher than individually defined meaningful relief score during the study.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=40 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=38 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=17 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Median Onset Time of First Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose	0.75 hours Interval 0.25 to 3.0	0.63 hours Interval 0.25 to 1.5	0.50 hours Interval 0.25 to 6.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Hours

Population: Number of subjects who achieved Meaningful Relief within 6 hours

Offset time is time of first no perceptible relief (STRRS score=0) with meaningful relief (score>0) at earlier time. STRRS score ranges from 0=no relief to 6=complete relief.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=40 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=23 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=15 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=17 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Median Offset Time of No Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose	8.00 hours Interval 3.0 to 24.0	8.00 hours Interval 1.25 to 9.0	8.00 hours Interval 3.0 to 24.0	10.00 hours Interval 2.0 to 12.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours Post-First Dose

Population: MITT population

Subjects were considered treatment failures if all of the STRRS scores were less than each individual's 'meaningful relief' scores. STRRS score ranges from 0=no relief to 6=complete relief.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=45 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=44 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Treatment Failures on STRRS Questionnaire Not treatment failures	46 subjects	27 subjects	20 subjects	23 subjects
Treatment Failures on STRRS Questionnaire Treatment failures	44 subjects	18 subjects	24 subjects	66 subjects

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 24 hours Post-First Dose

Population: MITT population

Subjects were allowed to use rescue medication at any time during the trial, but were discouraged from taking rescue medication within 2 hours of administration of the first dose of study drug.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=45 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=45 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Subjects Taking Rescue Medication	22 subjects	15 subjects	13 subjects	39 subjects

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours or immediately prior to taking rescue medication

Population: MITT population

11 questions scored on factors: effectiveness, side effects, convenience, overall satisfaction. TSQM vII scores range 0 to 100, with higher scores indicating a higher level of global satisfaction with treatment.

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=45 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=45 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Treatment Satisfaction Questionnaire for Medication (TSQM vII) Effectiveness	41.5 scores on a scale Standard Deviation 26.6	40.6 scores on a scale Standard Deviation 28.7	34.3 scores on a scale Standard Deviation 26.2	26.1 scores on a scale Standard Deviation 25.4
Treatment Satisfaction Questionnaire for Medication (TSQM vII) Side Effects	96.3 scores on a scale Standard Deviation 12.0	96.7 scores on a scale Standard Deviation 11.6	97.9 scores on a scale Standard Deviation 9.7	98.6 scores on a scale Standard Deviation 8.2
Treatment Satisfaction Questionnaire for Medication (TSQM vII) Convenience	77.2 scores on a scale Standard Deviation 15.1	73.0 scores on a scale Standard Deviation 17.4	69.3 scores on a scale Standard Deviation 16.8	71.3 scores on a scale Standard Deviation 14.6
Treatment Satisfaction Questionnaire for Medication (TSQM vII) Global Satisfaction	49.1 scores on a scale Standard Deviation 28.0	47.8 scores on a scale Standard Deviation 33.4	42.2 scores on a scale Standard Deviation 30.6	36.0 scores on a scale Standard Deviation 27.3

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 24 hours

Population: MITT population Number of subjects assessed at each hour is: N = Celecoxib 50mg/50mg, Celecoxib 100mg/Placebo, Celecoxib 100mg/50mg, Placebo

Subjects having First Perceptible Relief at each time point. Perceptible relief is score >0 on Sore Throat Relief Rating Scale(STRRS)(range: 0=no relief to 6=complete relief).

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=45 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=45 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo
First Perceptible Relief 12 hour-No onset subjects in hour	6 subjects	3 subjects	6 subjects	20 subjects
First Perceptible Relief 1 hour - Onset subjects in hour	68 subjects	29 subjects	22 subjects	40 subjects
First Perceptible Relief 1 hour - No onset subjects in hour	22 subjects	16 subjects	23 subjects	49 subjects
First Perceptible Relief 2 hour - Onset subjects in hour	13 subjects	10 subjects	9 subjects	11 subjects
First Perceptible Relief 2 hour-No onset subjects in hour	9 subjects	6 subjects	14 subjects	38 subjects
First Perceptible Relief 3 hour - Onset subjects in hour	1 subjects	2 subjects	0 subjects	2 subjects
First Perceptible Relief 3 hour-No onset subjects in hour	8 subjects	4 subjects	14 subjects	36 subjects
First Perceptible Relief 4 hour - Onset subjects in hour	0 subjects	0 subjects	2 subjects	4 subjects
First Perceptible Relief 4 hour- No onset subjects in hour	8 subjects	4 subjects	12 subjects	32 subjects
First Perceptible Relief 5 hour - Onset subjects in hour	0 subjects	0 subjects	1 subjects	4 subjects
First Perceptible Relief 5 hour-No onset subjects in hour	8 subjects	4 subjects	11 subjects	28 subjects
First Perceptible Relief 6 hour - Onset subjects in hour	0 subjects	1 subjects	3 subjects	1 subjects
First Perceptible Relief 6 hour-No onset subjects in hour	8 subjects	3 subjects	8 subjects	27 subjects
First Perceptible Relief 7 hour - Onset subjects in hour	0 subjects	0 subjects	1 subjects	1 subjects
First Perceptible Relief 7 hour-No onset subjects in hour	8 subjects	3 subjects	7 subjects	26 subjects
First Perceptible Relief 8 hour - Onset subjects in hour	0 subjects	0 subjects	1 subjects	2 subjects
First Perceptible Relief 8 hour-No onset subjects in hour	8 subjects	3 subjects	6 subjects	24 subjects
First Perceptible Relief 9 hour - Onset subjects in hour	2 subjects	0 subjects	0 subjects	2 subjects
First Perceptible Relief 9 hour-No onset subjects in hour	6 subjects	3 subjects	6 subjects	22 subjects
First Perceptible Relief 10 hour - Onset subjects in hour	0 subjects	0 subjects	0 subjects	0 subjects
First Perceptible Relief 10 hour-No onset subjects in hour	6 subjects	3 subjects	6 subjects	22 subjects
First Perceptible Relief 11 hour - Onset subjects in hour	0 subjects	0 subjects	0 subjects	1 subjects
First Perceptible Relief 11 hour-No onset subjects in hour (	6 subjects	3 subjects	6 subjects	21 subjects
First Perceptible Relief 12 hour - Onset subjects in hour	0 subjects	0 subjects	0 subjects	1 subjects
First Perceptible Relief 24 hour - Onset subjects in hour	1 subjects	0 subjects	0 subjects	2 subjects
First Perceptible Relief 24 hour-No onset subjects in hour	5 subjects	3 subjects	6 subjects	18 subjects

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 24 hours

Population: MITT population Number of subjects at each time point (in hour) is: N = Celecoxib 50mg/50mg, Celecoxib 100mg/Placebo, Celecoxib 100mg/50mg, Placebo

Subjects having No Perceptible Relief at each time point. No Perceptible relief is score = 0 on Sore Throat Relief Rating Scale (STRRS)(range: 0=no relief to 6=complete relief).

Outcome measures

Measure	Celecoxib 100mg (Pooled) n=90 Participants Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled	Placebo n=45 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=45 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo	Placebo n=89 Participants Dose 1 placebo followed 6-12 hours later by dose 2 placebo
No Perceptible Relief 24 hour-No offset subjects in hr (N=78,37,41, 81)	75 subjects	37 subjects	38 subjects	81 subjects
No Perceptible Relief 1 hour - Offset subjects in hour	0 subjects	0 subjects	0 subjects	0 subjects
No Perceptible Relief 1 hour-No offset subjects in hour	90 subjects	45 subjects	45 subjects	89 subjects
No Perceptible Relief 2 hour- Offset subjects in hour	0 subjects	1 subjects	0 subjects	1 subjects
No Perceptible Relief 2 hour-No offset subjects in hr	90 subjects	44 subjects	45 subjects	88 subjects
No Perceptible Relief 3 hour- Offset subjects in hour	1 subjects	0 subjects	1 subjects	0 subjects
No Perceptible Relief 3 hour-No offset subjects in hr	89 subjects	44 subjects	44 subjects	88 subjects
No Perceptible Relief 4 hour- Offset subjects in hour	0 subjects	0 subjects	0 subjects	0 subjects
No Perceptible Relief 4 hour-No offset subjects in hr	89 subjects	44 subjects	44 subjects	88 subjects
No Perceptible Relief 5 hour- Offset subjects in hour	1 subjects	0 subjects	0 subjects	0 subjects
No Perceptible Relief 5 hour-No offset subjects in hr	88 subjects	44 subjects	44 subjects	88 subjects
No Perceptible Relief 6 hour- Offset subjects in hour	0 subjects	0 subjects	0 subjects	1 subjects
No Perceptible Relief 6 hour-No offset subjects in hr	88 subjects	44 subjects	44 subjects	87 subjects
No Perceptible Relief 7 hour- Offset subjects in hour	4 subjects	2 subjects	2 subjects	1 subjects
No Perceptible Relief 7 hour-No offset subjects in hr	84 subjects	42 subjects	42 subjects	86 subjects
No Perceptible Relief 8 hour- Offset subjects in hour	1 subjects	2 subjects	0 subjects	0 subjects
No Perceptible Relief 8 hour-No offset subjects in hr	83 subjects	40 subjects	42 subjects	86 subjects
No Perceptible Relief 9 hour- Offset subjects in hour	1 subjects	3 subjects	1 subjects	0 subjects
No Perceptible Relief 9 hour-No offset subjects in hr	82 subjects	37 subjects	41 subjects	86 subjects
No Perceptible Relief 10 hour-Offset subjects in hour	2 subjects	0 subjects	0 subjects	3 subjects
No Perceptible Relief 10 hour-No offset subjects in hr	80 subjects	37 subjects	41 subjects	83 subjects
No Perceptible Relief 11 hour-Offset subjects in hour	1 subjects	0 subjects	0 subjects	0 subjects
No Perceptible Relief 11 hour-No offset subjects in hr	79 subjects	37 subjects	41 subjects	83 subjects
No Perceptible Relief 12 hour-Offset subjects in hour	1 subjects	0 subjects	0 subjects	2 subjects
No Perceptible Relief 12 hour-No offset subjects in hr	78 subjects	37 subjects	41 subjects	81 subjects
No Perceptible Relief 24 hour-Offset subjects in hour (N=78,37, 41, 81)	3 subjects	0 subjects	3 subjects	0 subjects

Adverse Events

Celecoxib 50mg/50mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Celecoxib 100mg/Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Celecoxib 100mg/50mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Celecoxib 50mg/50mg n=90 participants at risk Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg	Celecoxib 100mg/Placebo n=45 participants at risk Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo	Celecoxib 100mg/50mg n=45 participants at risk Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg	Placebo n=89 participants at risk Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Eye disorders Conjunctivitis	1.1% 1/90 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/45 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.2% 1/45 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	1.1% 1/89 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Dyspepsia	0.00% 0/90 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/45 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/45 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.2% 2/89 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Nausea	3.3% 3/90 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	4.4% 2/45 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/45 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	1.1% 1/89 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders Fatigue	1.1% 1/90 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.2% 1/45 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/45 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/89 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Otitis media	0.00% 0/90 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/45 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.2% 1/45 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	1.1% 1/89 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Nervous system disorders Dizziness	2.2% 2/90 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/45 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/45 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	1.1% 1/89 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Nervous system disorders Headache	2.2% 2/90 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/45 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/45 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/89 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/90 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/45 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.2% 1/45 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	1.1% 1/89 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Skin and subcutaneous tissue disorders Rash generalized	0.00% 0/90 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.2% 1/45 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.2% 1/45 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/89 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Gastrointestinal disorders Abdominal distension	0.00% 0/90 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.2% 1/45 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/45 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/89 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
General disorders Feeling abnormal	0.00% 0/90 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/45 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.2% 1/45 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/89 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Infections and infestations Viral rash	0.00% 0/90 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/45 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	2.2% 1/45 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.	0.00% 0/89 • Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.

Additional Information

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Phone: 1-800-718-1021

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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 mo 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