Pharyngitis
Conditions
Keywords
sore throat, acute pain
Brief summary
We are proposing a study in which we utilize and augment the sore throat pain model to assess the analgesic effectiveness of celecoxib compared to placebo in patients with painful pharyngitis under randomized, double-blind, placebo-controlled conditions.
Interventions
DRUGCelecoxib
dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
DRUGcelecoxib
dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
DRUGplacebo
dose 1 placebo followed 6-12 hours later by dose 2 placebo
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* The patient must have a diagnosis of pharyngitis with objective findings of tonsillo-pharyngitis. * The patient is willing to take nothing by mouth including inhaled treatments except trial medication during the two hours while at the site and following trial drug administration (e.g. not smoking, food, drink, candy, lozenges, chewing gum). The patient will be allowed food and drink between hours 2 and 24, but no other oral or inhaled treatments such as smoking, lozenges, chewing gum. After the two hour assessment, the patients will be allowed food and drink within one half-hour following any hourly evaluations sore throat.
Exclusion criteria
* The patient has used any analgesic/antipyretic within 1 dosing interval preceding administration of the first dose of trial medication. * The patient anticipates using any inhaled therapy including beta-agonists (e.g., ventolin) during the 24 hour trial period and, if used, has only used inhaled therapy on an intermittent basis in the week prior to the screening visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose | 2 hours Post-First Dose | Based on the Pain Intensity scores measured on a Visual Analogue Scale (PI-VAS: 0mm=no pain,100mm=worst possible pain), assessed by the subjects, the SPID2 is the area under the curve (AUC) over the 2-hour period post-first dose of the Pain Intensity Difference (PID) scores using the trapezoidal rule. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | 7 to 24 hours | Pain intensity (PI) on Swallowing as Measured by PI-VAS scale: 0mm=no pain, 100mm=worst possible pain. PID score was obtained by subtracting the PI at each time point from the Baseline PI score. An increase in scores indicated a lessening of subjects' pain as compared to Baseline scores, thus, higher scores indicated a greater reduction in pain. |
| Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose | up to 6 hours | The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The PID \[based on PI-VAS scale: 0mm=no pain, 100mm=worst possible pain\] was calculated as the difference between the pain intensity at the time and at baseline. |
| Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose | 7 to 24 hours | The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The PID \[based on PI-VAS scale: 0mm=no pain, 100mm=worst possible pain\] was calculated as the difference between the pain intensity at the time and at baseline. |
| Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | within the first 6 hours | STRRS score (scale: 0 no relief to 6 complete relief); a higher pain score indicated a greater reduction in pain. |
| Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose | 7 to 24 hours | STRRS score (scale: 0 no relief to 6 complete relief); a higher score indicated a greater reduction in pain. |
| Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 6 Hours Post-First Dose | at 6 hours | Subjects Achieving at Least 'Moderate Relief' as Measured by STRRS (range: 0=no relief to 6=complete relief); Moderate relief is defined as STRRS = 3). |
| Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | Within First 6 hours Post-First Dose | Pain intensity (PI) on Swallowing as Measured by PI-VAS scale: 0mm=no pain, 100mm=worst possible pain. Sore throat PID score was obtained by subtracting the PI at each time point from the Baseline PI score. Increase in scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain. |
| Time to Perceptible Pain Relief | Within 2 Hours Post-First Dose | Defined as time (measured by stopwatch) when subject began to feel any pain relieving effect from the drug |
| Time to Meaningful Pain Relief | Within 2 Hours Post-First Dose | The time (measured by stopwatch) when the subject felt their pain relief was meaningful to them was not estimable thus the number of subjects experiencing meaningful pain relief within 2 hours of first dose is reported |
| Time to Onset of Analgesia | Within 2 Hours Post-First Dose | Equal to time of perceptible pain relief when both perceptible pain relief and meaningful pain relief were experienced- the median time was not estimable thus the number of subjects with onset of analgesia within 2 hours of first dose is reported |
| Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose | 6 Hours Post-First Dose | Subject assessment of overall impression of study drug on 4 point scale from 1 (poor) to 4 (excellent) |
| Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | 12 and 24 hours Post-First Dose | Subject assessment of overall impression of study drug on 4 point scale from 1 (poor) to 4 (excellent) |
| Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 12 Hours Post-First Dose | 12 hours | Subjects Achieving at Least 'Moderate Relief' as Measured by STRRS (range: 0=no relief to 6=complete relief); Moderate relief is defined as STRRS = 3). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subjects With >= 50% Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose | 6 hours Post-First Dose | 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. |
| Subjects With >= 50% Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose | 12 hours Post-First Dose | 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. |
| Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose | 6 hours Post-First Dose | 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. |
| Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose | 12 hours Post-First Dose | 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. |
| Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 2 and 6 Hours Post-First Dose | 2 and 6 hours Post-First Dose | \>= 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. |
| Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 12 Hours Post-First Dose | 12 hours Post-First Dose | \>= 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. |
| Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 2 and 6 Hours Post-First Dose | 2 and 6 hours Post-First Dose | 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'. |
| Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose | 12 hours Post-First Dose | 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'. |
| Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Had Perceptible Relief Onset Time Within 1 Hour | Within 6 hours Post-First Dose | 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. |
| 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 | 12 and 24 hours Post-First Dose | 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 |
| Median Onset Time of First Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose | 24 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. |
| Median Offset Time of No Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose | 24 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. |
| Treatment Failures on STRRS Questionnaire | 24 hours Post-First Dose | 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. |
| Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | Within first 6 hours post-first dose | 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. |
| Treatment Satisfaction Questionnaire for Medication (TSQM vII) | 24 hours or immediately prior to taking rescue medication | 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. |
| First Perceptible Relief | up to 24 hours | 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). |
| No Perceptible Relief | up to 24 hours | 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). |
| Subjects Taking Rescue Medication | Within 24 hours Post-First Dose | 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. |
| Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose | 7 to 24 hours post-first dose | 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. |
| Sore Throat Pain Intensity Difference (SPID2) as Measured by Throat Soreness Scale (TSS) at 2 Hours Post-First Dose | 2 hour period Post-First Dose | 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. |
| Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose | Within 6 hours Post-First Dose | 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. |
| Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose | 7 to 24 hours Post-First Dose | 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. |
| Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | Within 6 hours Post-First Dose | 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. |
| Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 7 to 24 hours Post-First Dose | 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. |
| Sum of Sore Throat Pain Intensity Difference (SPID2) as Measured by Difficulty Swallowing Scale (DSS) at 2 Hours Post-First Dose | Over 2 hour Period Post-First Dose | 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. |
| Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | Within 6 hours Post-First Dose | 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. |
| Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 7 to 24 hours Post-First Dose | 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. |
| Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 6 Hours Post-First Dose | At 6 hours | 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. |
| Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 12 Hours Post-First Dose | At 12 Hours | 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. |
| Total Pain Relief (TOTPAR) at 2 and 6 Hours Post-First Dose | 2 and 6 hours Post-First Dose | TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief). |
| Total Pain Relief (TOTPAR) at 12 and 24 Hours Post-First Dose | 12 and 24 hours Post-First Dose | TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief). |
Countries
United States
Participant flow
Recruitment details
1 center in the United States.
Participants by arm
| Arm | Count |
|---|---|
| Celecoxib 50mg/50mg Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg | 90 |
| Celecoxib 100mg/Placebo Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo | 45 |
| Celecoxib 100mg/50mg Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg | 45 |
| Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo | 89 |
| Total | 269 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Celecoxib 50mg/50mg | Celecoxib 100mg/Placebo | Celecoxib 100mg/50mg | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 19.5 years STANDARD_DEVIATION 1.3 | 19.6 years STANDARD_DEVIATION 1.4 | 19.9 years STANDARD_DEVIATION 2.3 | 19.3 years STANDARD_DEVIATION 1.4 | 19.5 years STANDARD_DEVIATION 1.5 |
| Sex: Female, Male Female | 55 Participants | 25 Participants | 15 Participants | 49 Participants | 144 Participants |
| Sex: Female, Male Male | 35 Participants | 20 Participants | 30 Participants | 40 Participants | 125 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 90 | 0 / 45 | 0 / 45 | 0 / 89 |
| other Total, other adverse events | 8 / 90 | 5 / 45 | 5 / 45 | 6 / 89 |
| serious Total, serious adverse events | 0 / 90 | 0 / 45 | 0 / 45 | 0 / 89 |
Outcome results
Primary
Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose
Based on the Pain Intensity scores measured on a Visual Analogue Scale (PI-VAS: 0mm=no pain,100mm=worst possible pain), assessed by the subjects, the SPID2 is the area under the curve (AUC) over the 2-hour period post-first dose of the Pain Intensity Difference (PID) scores using the trapezoidal rule.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib 100mg (Pooled) | 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 2.2 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose | 9.4 units on a scale * hours | Standard Error 2.21 |
Comparison: Null hypothesis: No difference in SPID2 (PI-VAS) at two hours between celecoxib 100 mg and placebo. Sample size was based on an expected effect size of 0.42 (from earlier studies), 80% power and an alpha of 0.05.p-value: 0.000395% CI: [5.5, 17.9]generalized linear model
Secondary
Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose
Subject assessment of overall impression of study drug on 4 point scale from 1 (poor) to 4 (excellent)
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib 100mg (Pooled) | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Fair (2) - 24 hours | 25 subjects |
| Celecoxib 100mg (Pooled) | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Good (3) - 24 hours | 20 subjects |
| Celecoxib 100mg (Pooled) | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Excellent (4) - 12 hours | 8 subjects |
| Celecoxib 100mg (Pooled) | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Poor (1) - 24 hours | 37 subjects |
| Celecoxib 100mg (Pooled) | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Good (3) - 12 hours | 23 subjects |
| Celecoxib 100mg (Pooled) | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Fair (2) - 12 hours | 21 subjects |
| Celecoxib 100mg (Pooled) | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Excellent (4) - 24 hours | 7 subjects |
| Celecoxib 100mg (Pooled) | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Poor (1) - 12 hours | 37 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Good (3) - 12 hours | 10 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Poor (1) - 12 hours | 18 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Excellent (4) - 24 hours | 4 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Good (3) - 24 hours | 13 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Fair (2) - 24 hours | 7 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Poor (1) - 24 hours | 21 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Fair (2) - 12 hours | 11 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Excellent (4) - 12 hours | 5 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Good (3) - 12 hours | 13 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Excellent (4) - 24 hours | 2 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Excellent (4) - 12 hours | 0 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Fair (2) - 12 hours | 11 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Poor (1) - 12 hours | 20 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Good (3) - 24 hours | 9 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Fair (2) - 24 hours | 15 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Poor (1) - 24 hours | 18 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Fair (2) - 12 hours | 18 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Excellent (4) - 12 hours | 1 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Poor (1) - 24 hours | 57 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Fair (2) - 24 hours | 15 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Poor (1) - 12 hours | 56 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Excellent (4) - 24 hours | 2 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Good (3) - 12 hours | 10 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose | Good (3) - 24 hours | 13 subjects |
p-value: <0.001Mantel Haenszel
p-value: 0.002Mantel Haenszel
p-value: 0.015Mantel Haenszel
p-value: 0.411Mantel Haenszel
p-value: 0.93Mantel Haenszel
p-value: 0.438Mantel Haenszel
p-value: 0.002Mantel Haenszel
p-value: 0.013Mantel Haenszel
p-value: 0.015Mantel Haenszel
p-value: 0.748Mantel Haenszel
p-value: 0.958Mantel Haenszel
p-value: 0.747Mantel Haenszel
Secondary
Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose
Subject assessment of overall impression of study drug on 4 point scale from 1 (poor) to 4 (excellent)
Time frame: 6 Hours Post-First Dose
Population: MITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib 100mg (Pooled) | Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose | Fair (2) | 25 subjects |
| Celecoxib 100mg (Pooled) | Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose | Good (3) | 24 subjects |
| Celecoxib 100mg (Pooled) | Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose | Poor (1) | 35 subjects |
| Celecoxib 100mg (Pooled) | Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose | Excellent (4) | 5 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose | Fair (2) | 27 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose | Poor (1) | 33 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose | Good (3) | 25 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose | Excellent (4) | 4 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose | Poor (1) | 60 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose | Excellent (4) | 2 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose | Fair (2) | 22 subjects |
| Placebo | Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose | Good (3) | 5 subjects |
p-value: <0.001Mantel Haenszel
p-value: <0.001Mantel Haenszel
p-value: 0.889Mantel Haenszel
Secondary
Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose
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.
Time frame: 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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 100mg (Pooled) | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | 12 hours | 19.01 units on a scale | Standard Error 2.5 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | 11 hours | 19.65 units on a scale | Standard Error 2.4 |
| Celecoxib 100mg (Pooled) | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | 7 hours | 20.82 units on a scale | Standard Error 2.3 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | 10 hours | 21.26 units on a scale | Standard Error 2.4 |
| Celecoxib 100mg (Pooled) | 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 |
| Placebo | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | 10 hours | 18.02 units on a scale | Standard Error 3.4 |
| Placebo | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | 11 hours | 17.43 units on a scale | Standard Error 3.4 |
| Placebo | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | 24 hours | 16.50 units on a scale | Standard Error 3.66 |
| Placebo | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | 8 hours | 20.81 units on a scale | Standard Error 3.24 |
| Placebo | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | 9 hours | 19.18 units on a scale | Standard Error 3.35 |
| Placebo | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | 12 hours | 15.01 units on a scale | Standard Error 3.54 |
| Placebo | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | 7 hours | 22.01 units on a scale | Standard Error 3.26 |
| Placebo | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | 8 hours | 19.93 units on a scale | Standard Error 3.23 |
| Placebo | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | 7 hours | 18.34 units on a scale | Standard Error 3.25 |
| Placebo | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | 9 hours | 18.87 units on a scale | Standard Error 3.33 |
| Placebo | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | 10 hours | 18.06 units on a scale | Standard Error 3.39 |
| Placebo | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | 11 hours | 18.99 units on a scale | Standard Error 3.39 |
| Placebo | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | 12 hours | 20.22 units on a scale | Standard Error 3.52 |
| Placebo | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | 24 hours | 19.44 units on a scale | Standard Error 3.65 |
| Placebo | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | 9 hours | 9.92 units on a scale | Standard Error 2.38 |
| Placebo | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | 24 hours | 12.81 units on a scale | Standard Error 2.61 |
| Placebo | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | 12 hours | 8.60 units on a scale | Standard Error 2.52 |
| Placebo | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | 7 hours | 9.32 units on a scale | Standard Error 2.33 |
| Placebo | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | 8 hours | 8.12 units on a scale | Standard Error 2.31 |
| Placebo | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | 11 hours | 9.29 units on a scale | Standard Error 2.43 |
| Placebo | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose | 10 hours | 9.56 units on a scale | Standard Error 2.42 |
p-value: 0.001Generalized Linear Model
p-value: <0.001Generalized linear model
p-value: 0.006Generalized linear model
p-value: 0.007Generalized linear model
p-value: 0.014Generalized linear model
p-value: 0.012Generalized linear model
p-value: 0.365Generalized linear model
Secondary
Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose
Pain intensity (PI) on Swallowing as Measured by PI-VAS scale: 0mm=no pain, 100mm=worst possible pain. Sore throat PID score was obtained by subtracting the PI at each time point from the Baseline PI score. Increase in scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain.
Time frame: 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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 100mg (Pooled) | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 5 hours | 24.12 units on a scale | Standard Error 2.26 |
| Celecoxib 100mg (Pooled) | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 15 min | 1.62 units on a scale | Standard Error 0.64 |
| Celecoxib 100mg (Pooled) | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 75 min | 17.24 units on a scale | Standard Error 1.62 |
| Celecoxib 100mg (Pooled) | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 3 hours | 27.90 units on a scale | Standard Error 2.29 |
| Celecoxib 100mg (Pooled) | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 4 hours | 25.52 units on a scale | Standard Error 2.31 |
| Celecoxib 100mg (Pooled) | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 90 min | 22.39 units on a scale | Standard Error 1.88 |
| Celecoxib 100mg (Pooled) | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 6 hours | 21.42 units on a scale | Standard Error 2.24 |
| Celecoxib 100mg (Pooled) | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 30 min | 4.70 units on a scale | Standard Error 0.9 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 45 min | 9.57 units on a scale | Standard Error 1.22 |
| Celecoxib 100mg (Pooled) | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 60 min | 12.18 units on a scale | Standard Error 1.47 |
| Celecoxib 100mg (Pooled) | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 2 hours | 26.63 units on a scale | Standard Error 2.19 |
| Placebo | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 60 min | 11.43 units on a scale | Standard Error 1.47 |
| Placebo | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 3 hours | 22.21 units on a scale | Standard Error 2.29 |
| Placebo | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 4 hours | 23.15 units on a scale | Standard Error 2.31 |
| Placebo | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 5 hours | 23.56 units on a scale | Standard Error 2.26 |
| Placebo | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 45 min | 7.05 units on a scale | Standard Error 1.23 |
| Placebo | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 6 hours | 20.59 units on a scale | Standard Error 2.24 |
| Placebo | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 2 hours | 21.51 units on a scale | Standard Error 2.19 |
| Placebo | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 15 min | 1.92 units on a scale | Standard Error 0.64 |
| Placebo | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 75 min | 13.24 units on a scale | Standard Error 1.62 |
| Placebo | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 90 min | 17.00 units on a scale | Standard Error 1.88 |
| Placebo | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 1.75 hours | 18.80 units on a scale | Standard Error 1.99 |
| Placebo | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 30 min | 4.93 units on a scale | Standard Error 0.9 |
| Placebo | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 6 hours | 9.04 units on a scale | Standard Error 2.26 |
| Placebo | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 3 hours | 9.06 units on a scale | Standard Error 2.31 |
| Placebo | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 15 min | 0.40 units on a scale | Standard Error 0.64 |
| Placebo | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 30 min | 2.14 units on a scale | Standard Error 0.91 |
| Placebo | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 60 min | 5.34 units on a scale | Standard Error 1.48 |
| Placebo | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 75 min | 6.60 units on a scale | Standard Error 1.64 |
| Placebo | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 90 min | 6.75 units on a scale | Standard Error 1.9 |
| Placebo | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 1.75 hours | 7.41 units on a scale | Standard Error 2.01 |
| Placebo | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 2 hours | 8.06 units on a scale | Standard Error 2.21 |
| Placebo | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 4 hours | 10.35 units on a scale | Standard Error 2.33 |
| Placebo | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 5 hours | 10.47 units on a scale | Standard Error 2.28 |
| Placebo | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose | 45 min | 3.85 units on a scale | Standard Error 1.24 |
p-value: 0.212Generalized linear model
p-value: 0.056Generalized linear model
p-value: 0.005Generalized linear model
p-value: 0.002Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
Secondary
Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose
STRRS score (scale: 0 no relief to 6 complete relief); a higher score indicated a greater reduction in pain.
Time frame: 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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose | 12 hours | 1.42 scores on a scale | Standard Error 0.25 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose | 7 hours | 2.00 scores on a scale | Standard Error 0.24 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose | 8 hours | 1.80 scores on a scale | Standard Error 0.24 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose | 9 hours | 1.76 scores on a scale | Standard Error 0.25 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose | 10 hours | 1.67 scores on a scale | Standard Error 0.25 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose | 11 hours | 1.58 scores on a scale | Standard Error 0.25 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose | 24 hours | 1.62 scores on a scale | Standard Error 0.27 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose | 10 hours | 1.51 scores on a scale | Standard Error 0.25 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose | 7 hours | 1.67 scores on a scale | Standard Error 0.24 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose | 24 hours | 1.60 scores on a scale | Standard Error 0.27 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose | 11 hours | 1.60 scores on a scale | Standard Error 0.25 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose | 12 hours | 1.53 scores on a scale | Standard Error 0.25 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose | 9 hours | 1.56 scores on a scale | Standard Error 0.25 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose | 8 hours | 1.71 scores on a scale | Standard Error 0.24 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose | 9 hours | 1.08 scores on a scale | Standard Error 0.17 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose | 24 hours | 1.31 scores on a scale | Standard Error 0.19 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose | 10 hours | 1.08 scores on a scale | Standard Error 0.18 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose | 7 hours | 0.93 scores on a scale | Standard Error 0.17 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose | 11 hours | 1.10 scores on a scale | Standard Error 0.18 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose | 12 hours | 1.07 scores on a scale | Standard Error 0.18 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose | 8 hours | 0.97 scores on a scale | Standard Error 0.17 |
p-value: 0.001Generalized linear model
p-value: 0.005Generalized linear model
p-value: 0.046Generalized linear model
p-value: 0.046Generalized linear model
p-value: 0.111Generalized linear model
p-value: 0.226Generalized linear model
p-value: 0.537Generalized linear model
Secondary
Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 12 Hours Post-First Dose
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).
Time frame: 12 hours
Population: MITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celecoxib 100mg (Pooled) | Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 12 Hours Post-First Dose | 21 subjects |
| Placebo | Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 12 Hours Post-First Dose | 13 subjects |
| Placebo | Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 12 Hours Post-First Dose | 12 subjects |
| Placebo | Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 12 Hours Post-First Dose | 14 subjects |
p-value: 0.20295% CI: [0.8, 3.5]Regression, Logistic
p-value: 0.07795% CI: [0.9, 5.1]Regression, Logistic
p-value: 0.13495% CI: [0.8, 4.7]Regression, Logistic
p-value: 0.67195% CI: [0.4, 1.9]Regression, Logistic
p-value: 0.48495% CI: [0.3, 1.7]Regression, Logistic
p-value: 0.81495% CI: [0.4, 2.8]Regression, Logistic
Secondary
Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 6 Hours Post-First Dose
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).
Time frame: at 6 hours
Population: MITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celecoxib 100mg (Pooled) | Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 6 Hours Post-First Dose | 28 subjects |
| Placebo | Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 6 Hours Post-First Dose | 31 subjects |
| Placebo | Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 6 Hours Post-First Dose | 13 subjects |
p-value: 0.0195% CI: [1.3, 5.5]Regression, Logistic
p-value: 0.00395% CI: [1.5, 6.4]Regression, Logistic
p-value: 0.63495% CI: [0.6, 2.2]Regression, Logistic
Secondary
Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose
STRRS score (scale: 0 no relief to 6 complete relief); a higher pain score indicated a greater reduction in pain.
Time frame: 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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 100mg (Pooled) | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 5 hours | 2.00 scores on a scale | Standard Error 0.17 |
| Celecoxib 100mg (Pooled) | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 60 min | 1.22 scores on a scale | Standard Error 0.12 |
| Celecoxib 100mg (Pooled) | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 4 hours | 2.08 scores on a scale | Standard Error 0.17 |
| Celecoxib 100mg (Pooled) | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 3 hours | 2.13 scores on a scale | Standard Error 0.17 |
| Celecoxib 100mg (Pooled) | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 75 min | 1.58 scores on a scale | Standard Error 0.13 |
| Celecoxib 100mg (Pooled) | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 6 hours | 1.81 scores on a scale | Standard Error 0.17 |
| Celecoxib 100mg (Pooled) | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 15 min | 0.12 scores on a scale | Standard Error 0.04 |
| Celecoxib 100mg (Pooled) | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 90 min | 1.88 scores on a scale | Standard Error 0.15 |
| Celecoxib 100mg (Pooled) | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 45 min | 0.74 scores on a scale | Standard Error 0.09 |
| Celecoxib 100mg (Pooled) | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 30 min | 0.41 scores on a scale | Standard Error 0.07 |
| Celecoxib 100mg (Pooled) | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 2 hours | 2.22 scores on a scale | Standard Error 0.17 |
| Celecoxib 100mg (Pooled) | 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 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 2 hours | 1.93 scores on a scale | Standard Error 0.17 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 1.75 hours | 1.74 scores on a scale | Standard Error 0.16 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 4 hours | 1.96 scores on a scale | Standard Error 0.17 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 5 hours | 1.97 scores on a scale | Standard Error 0.17 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 45 min | 0.69 scores on a scale | Standard Error 0.09 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 6 hours | 1.86 scores on a scale | Standard Error 0.17 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 30 min | 0.34 scores on a scale | Standard Error 0.07 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 60 min | 1.01 scores on a scale | Standard Error 0.12 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 3 hours | 1.92 scores on a scale | Standard Error 0.17 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 75 min | 1.27 scores on a scale | Standard Error 0.13 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 90 min | 1.61 scores on a scale | Standard Error 0.15 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 15 min | 0.09 scores on a scale | Standard Error 0.04 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 6 hours | 0.96 scores on a scale | Standard Error 0.17 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 1.75 hours | 0.93 scores on a scale | Standard Error 0.16 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 15 min | 0.16 scores on a scale | Standard Error 0.04 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 30 min | 0.34 scores on a scale | Standard Error 0.07 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 45 min | 0.52 scores on a scale | Standard Error 0.09 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 60 min | 0.64 scores on a scale | Standard Error 0.12 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 75 min | 0.79 scores on a scale | Standard Error 0.14 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 90 min | 0.88 scores on a scale | Standard Error 0.15 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 2 hours | 0.92 scores on a scale | Standard Error 0.17 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 3 hours | 0.92 scores on a scale | Standard Error 0.17 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 4 hours | 1.10 scores on a scale | Standard Error 0.17 |
| Placebo | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose | 5 hours | 1.07 scores on a scale | Standard Error 0.17 |
p-value: 0.537Generalized linear model
p-value: 0.697Generalized linear model
p-value: 0.203Generalized linear model
p-value: 0.003Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
Secondary
Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose
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.
Time frame: 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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose | 9 hours | 193.2 units on a scale * hours | Standard Error 23.1 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose | 24 hours | 434.8 units on a scale * hours | Standard Error 69 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose | 8 hours | 173.2 units on a scale * hours | Standard Error 20.3 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose | 7 hours | 151.8 units on a scale * hours | Standard Error 17.5 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose | 12 hours | 245.7 units on a scale * hours | Standard Error 31.6 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose | 10 hours | 211.8 units on a scale * hours | Standard Error 25.9 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose | 11 hours | 229.5 units on a scale * hours | Standard Error 28.7 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose | 24 hours | 444.7 units on a scale * hours | Standard Error 68.8 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose | 10 hours | 168.6 units on a scale * hours | Standard Error 25.8 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose | 8 hours | 130.8 units on a scale * hours | Standard Error 20.2 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose | 12 hours | 206.8 units on a scale * hours | Standard Error 31.5 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose | 11 hours | 187.2 units on a scale * hours | Standard Error 28.6 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose | 7 hours | 111.6 units on a scale * hours | Standard Error 17.5 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose | 9 hours | 150.2 units on a scale * hours | Standard Error 23 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose | 24 hours | 231.0 units on a scale * hours | Standard Error 49.2 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose | 7 hours | 56.6 units on a scale * hours | Standard Error 12.5 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose | 8 hours | 65.4 units on a scale * hours | Standard Error 14.5 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose | 9 hours | 74.4 units on a scale * hours | Standard Error 16.5 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose | 11 hours | 93.5 units on a scale * hours | Standard Error 20.5 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose | 12 hours | 102.5 units on a scale * hours | Standard Error 22.5 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose | 10 hours | 84.1 units on a scale * hours | Standard Error 18.4 |
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.017Generalized linear model
p-value: 0.011Generalized linear model
p-value: 0.009Generalized linear model
p-value: 0.008Generalized linear model
p-value: 0.008Generalized linear model
p-value: 0.008Generalized linear model
p-value: 0.008Generalized linear model
p-value: 0.012Generalized linear model
p-value: 0.904Generalized linear model
p-value: 0.891Generalized linear model
p-value: 0.929Generalized linear model
p-value: 0.994Generalized linear model
p-value: 0.933Generalized linear model
p-value: 0.876Generalized linear model
p-value: 0.622Generalized linear model
p-value: 0.081Generalized linear model
p-value: 0.117Generalized linear model
p-value: 0.152Generalized linear model
p-value: 0.171Generalized linear model
p-value: 0.197Generalized linear model
p-value: 0.244Generalized linear model
p-value: 0.708Generalized linear model
p-value: 0.106Generalized linear model
p-value: 0.14Generalized linear model
p-value: 0.188Generalized linear model
p-value: 0.239Generalized linear model
p-value: 0.297Generalized linear model
p-value: 0.383Generalized linear model
p-value: 0.919Generalized linear model
p-value: <0.001Generalized linear model
Secondary
Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose
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.
Time frame: 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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose | 2 hours | 21.3 units on a scale * hours | Standard Error 2.3 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose | 3 hours | 43.1 units on a scale * hours | Standard Error 4.3 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose | 4 hours | 65.8 units on a scale * hours | Standard Error 6.5 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose | 5 hours | 89.2 units on a scale * hours | Standard Error 8.5 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose | 6 hours | 111.2 units on a scale * hours | Standard Error 10.5 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose | 60 min | 4.9 units on a scale * hours | Standard Error 0.7 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose | 75 min | 8.0 units on a scale * hours | Standard Error 1 |
| 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 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose | 90 min | 11.8 units on a scale * hours | Standard Error 1.4 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose | 30 min | 1.1 units on a scale * hours | Standard Error 0.2 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose | 1.75 hours | 16.2 units on a scale * hours | Standard Error 1.8 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose | 45 min | 2.6 units on a scale * hours | Standard Error 0.4 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose | 6 hours | 47.6 units on a scale * hours | Standard Error 10.6 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose | 4 hours | 27.4 units on a scale * hours | Standard Error 6.5 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose | 30 min | 0.4 units on a scale * hours | Standard Error 0.2 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose | 45 min | 1.1 units on a scale * hours | Standard Error 0.5 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose | 60 min | 2.3 units on a scale * hours | Standard Error 0.7 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose | 75 min | 3.8 units on a scale * hours | Standard Error 1 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose | 90 min | 5.4 units on a scale * hours | Standard Error 1.4 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose | 1.75 hours | 7.2 units on a scale * hours | Standard Error 1.8 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose | 2 hours | 9.1 units on a scale * hours | Standard Error 2.3 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose | 3 hours | 17.7 units on a scale * hours | Standard Error 4.4 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose | 5 hours | 37.8 units on a scale * hours | Standard Error 8.6 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose | 15 min | 0.1 units on a scale * hours | Standard Error 0.1 |
p-value: 0.18Generalized Linear Model
p-value: 0.069Generalized linear model
p-value: 0.01Generalized linear model
p-value: 0.002Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.096Generalized linear model
p-value: 0.034Generalized linear model
p-value: 0.022Generalized linear model
p-value: 0.01Generalized linear model
p-value: 0.005Generalized linear model
p-value: 0.002Generalized linear model
p-value: 0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.741Generalized linear model
p-value: 0.759Generalized linear model
p-value: 0.775Generalized linear model
p-value: 0.561Generalized linear model
p-value: 0.419Generalized linear model
p-value: 0.237Generalized linear model
p-value: 0.146Generalized linear model
p-value: 0.113Generalized linear model
p-value: 0.086Generalized linear model
p-value: 0.111Generalized linear model
p-value: 0.183Generalized linear model
p-value: 0.259Generalized linear model
Secondary
Time to Meaningful Pain Relief
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
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celecoxib 100mg (Pooled) | Time to Meaningful Pain Relief | 36 subjects |
| Placebo | Time to Meaningful Pain Relief | 33 subjects |
| Placebo | Time to Meaningful Pain Relief | 15 subjects |
Comparison: For subjects who did not experience meaningful pain relief within 2 hours post-first dose, the time to meaningful pain relief was censored at 2 hours.p-value: <0.05Log Rank
Comparison: For subjects who did not experience meaningful pain relief within 2 hours post-first dose, the time to meaningful pain relief was censored at 2 hoursp-value: <0.05Log Rank
Secondary
Time to Onset of Analgesia
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
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celecoxib 100mg (Pooled) | Time to Onset of Analgesia | 36 subjects |
| Placebo | Time to Onset of Analgesia | 34 subjects |
| Placebo | Time to Onset of Analgesia | 15 subjects |
Comparison: For subjects who did not experience onset of analgesia within 2 hours post-first dose, the time to onset of analgesia was censored at 2 hoursp-value: <0.05Log Rank
Comparison: For subjects who did not experience onset of analgesia within 2 hours post-first dose, the time to onset of analgesia was censored at 2 hoursp-value: <0.05Log Rank
Secondary
Time to Perceptible Pain Relief
Defined as time (measured by stopwatch) when subject began to feel any pain relieving effect from the drug
Time frame: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Celecoxib 100mg (Pooled) | Time to Perceptible Pain Relief | 49 minutes |
| Placebo | Time to Perceptible Pain Relief | 61 minutes |
| Placebo | Time to Perceptible Pain Relief | 97 minutes |
Comparison: For subjects who did not experience perceptible pain relief within 2 hours post-first dose, the time to perceptible pain relief was censored at 2 hoursp-value: <0.05Log Rank
Comparison: For subjects who did not experience perceptible pain relief within 2 hours post-first dose, the time to perceptible pain relief was censored at 2 hoursp-value: <0.05Log Rank
Comparison: For subjects who did not experience perceptible pain relief within 2 hours post-first dose, the time to perceptible pain relief was censored at 2 hoursp-value: <0.05Log Rank
Other Pre-specified
Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose
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.
Time frame: 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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 2.7 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 8 hours | 17.29 units on a scale | Standard Error 3.37 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 12 hours | 11.44 units on a scale | Standard Error 3.55 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 9 hours | 15.10 units on a scale | Standard Error 3.32 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 11 hours | 12.99 units on a scale | Standard Error 3.46 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 10 hours | 14.32 units on a scale | Standard Error 3.38 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 7 hours | 18.11 units on a scale | Standard Error 3.32 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 24 hours | 13.67 units on a scale | Standard Error 3.83 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 7 hours | 11.38 units on a scale | Standard Error 3.32 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 8 hours | 13.40 units on a scale | Standard Error 3.37 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 11 hours | 13.13 units on a scale | Standard Error 3.46 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 12 hours | 13.41 units on a scale | Standard Error 3.55 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 24 hours | 13.24 units on a scale | Standard Error 3.82 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 9 hours | 12.68 units on a scale | Standard Error 3.32 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 10 hours | 11.68 units on a scale | Standard Error 3.38 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 24 hours | 8.79 units on a scale | Standard Error 2.72 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 9 hours | 5.46 units on a scale | Standard Error 2.36 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 11 hours | 5.22 units on a scale | Standard Error 2.46 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 8 hours | 4.88 units on a scale | Standard Error 2.39 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 10 hours | 5.85 units on a scale | Standard Error 2.41 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 12 hours | 5.30 units on a scale | Standard Error 2.53 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 7 hours | 4.86 units on a scale | Standard Error 2.36 |
p-value: 0.001Generalized linear model
p-value: 0.002Generalized linear model
p-value: 0.007Generalized linear model
p-value: 0.015Generalized linear model
p-value: 0.033Generalized linear model
p-value: 0.036Generalized linear model
p-value: 0.5Generalized linear model
Other Pre-specified
Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose
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.
Time frame: 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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 1.75 hours | 15.15 units on a scale | Standard Error 2.11 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 3 hours | 18.39 units on a scale | Standard Error 2.17 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 4 hours | 18.27 units on a scale | Standard Error 2.33 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 30 min | 3.14 units on a scale | Standard Error 1.21 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 5 hours | 18.11 units on a scale | Standard Error 2.31 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 6 hours | 16.43 units on a scale | Standard Error 2.27 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 45 min | 5.75 units on a scale | Standard Error 1.43 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 60 min | 8.02 units on a scale | Standard Error 1.65 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 75 min | 10.47 units on a scale | Standard Error 1.84 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 90 min | 12.21 units on a scale | Standard Error 1.99 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 15 min | 1.16 units on a scale | Standard Error 0.89 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 2 hours | 16.50 units on a scale | Standard Error 2.25 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 6 hours | 5.70 units on a scale | Standard Error 2.29 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 2 hours | 4.99 units on a scale | Standard Error 2.26 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 15 min | 0.81 units on a scale | Standard Error 0.89 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 30 min | 1.11 units on a scale | Standard Error 1.21 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 60 min | 3.53 units on a scale | Standard Error 1.66 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 75 min | 3.95 units on a scale | Standard Error 1.85 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 90 min | 3.97 units on a scale | Standard Error 2 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 1.75 hours | 4.45 units on a scale | Standard Error 2.12 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 3 hours | 4.20 units on a scale | Standard Error 2.18 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 4 hours | 7.28 units on a scale | Standard Error 2.34 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 5 hours | 6.02 units on a scale | Standard Error 2.32 |
| Placebo | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 45 min | 2.85 units on a scale | Standard Error 1.44 |
p-value: 0.775Generalized linear model
p-value: 0.094Generalized linear model
p-value: 0.114Generalized linear model
p-value: 0.005Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.001Generalized linear model
Other Pre-specified
Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 12 Hours Post-First Dose
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.
Time frame: At 12 Hours
Population: MITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celecoxib 100mg (Pooled) | Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 12 Hours Post-First Dose | 24 subjects |
| Placebo | Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 12 Hours Post-First Dose | 12 subjects |
| Placebo | Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 12 Hours Post-First Dose | 10 subjects |
| Placebo | Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 12 Hours Post-First Dose | 12 subjects |
p-value: 0.0395% CI: [1.1, 5]Regression, Logistic
p-value: 0.06495% CI: [1, 5.7]Regression, Logistic
p-value: 0.20195% CI: [0.7, 4.6]Regression, Logistic
p-value: 0.57595% CI: [0.5, 3]Regression, Logistic
p-value: 195% CI: [0.4, 2.2]Regression, Logistic
p-value: 0.62495% CI: [0.5, 3.3]Regression, Logistic
Other Pre-specified
Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 6 Hours Post-First Dose
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.
Time frame: At 6 hours
Population: MITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celecoxib 100mg (Pooled) | Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 6 Hours Post-First Dose | 22 subjects |
| Placebo | Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 6 Hours Post-First Dose | 24 subjects |
| Placebo | Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 6 Hours Post-First Dose | 14 subjects |
p-value: 0.14995% CI: [0.8, 3.7]Regression, Logistic
p-value: 0.07695% CI: [0.9, 4.1]Regression, Logistic
p-value: 0.73395% CI: [0.6, 2.2]Regression, Logistic
Other Pre-specified
First Perceptible Relief
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).
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib 100mg (Pooled) | First Perceptible Relief | 9 hour - Onset subjects in hour | 2 subjects |
| Celecoxib 100mg (Pooled) | First Perceptible Relief | 9 hour-No onset subjects in hour | 6 subjects |
| Celecoxib 100mg (Pooled) | First Perceptible Relief | 10 hour - Onset subjects in hour | 0 subjects |
| Celecoxib 100mg (Pooled) | First Perceptible Relief | 10 hour-No onset subjects in hour | 6 subjects |
| Celecoxib 100mg (Pooled) | First Perceptible Relief | 7 hour-No onset subjects in hour | 8 subjects |
| Celecoxib 100mg (Pooled) | First Perceptible Relief | 11 hour - Onset subjects in hour | 0 subjects |
| Celecoxib 100mg (Pooled) | First Perceptible Relief | 11 hour-No onset subjects in hour ( | 6 subjects |
| Celecoxib 100mg (Pooled) | First Perceptible Relief | 24 hour - Onset subjects in hour | 1 subjects |
| Celecoxib 100mg (Pooled) | First Perceptible Relief | 24 hour-No onset subjects in hour | 5 subjects |
| Celecoxib 100mg (Pooled) | First Perceptible Relief | 1 hour - Onset subjects in hour | 68 subjects |
| Celecoxib 100mg (Pooled) | First Perceptible Relief | 6 hour-No onset subjects in hour | 8 subjects |
| Celecoxib 100mg (Pooled) | First Perceptible Relief | 2 hour - Onset subjects in hour | 13 subjects |
| Celecoxib 100mg (Pooled) | First Perceptible Relief | 2 hour-No onset subjects in hour | 9 subjects |
| Celecoxib 100mg (Pooled) | First Perceptible Relief | 3 hour - Onset subjects in hour | 1 subjects |
| Celecoxib 100mg (Pooled) | First Perceptible Relief | 3 hour-No onset subjects in hour | 8 subjects |
| Celecoxib 100mg (Pooled) | First Perceptible Relief | 1 hour - No onset subjects in hour | 22 subjects |
| Celecoxib 100mg (Pooled) | First Perceptible Relief | 4 hour - Onset subjects in hour | 0 subjects |
| Celecoxib 100mg (Pooled) | First Perceptible Relief | 4 hour- No onset subjects in hour | 8 subjects |
| Celecoxib 100mg (Pooled) | First Perceptible Relief | 12 hour - Onset subjects in hour | 0 subjects |
| Celecoxib 100mg (Pooled) | First Perceptible Relief | 5 hour - Onset subjects in hour | 0 subjects |
| Celecoxib 100mg (Pooled) | First Perceptible Relief | 5 hour-No onset subjects in hour | 8 subjects |
| Celecoxib 100mg (Pooled) | First Perceptible Relief | 6 hour - Onset subjects in hour | 0 subjects |
| Celecoxib 100mg (Pooled) | First Perceptible Relief | 7 hour - Onset subjects in hour | 0 subjects |
| Celecoxib 100mg (Pooled) | First Perceptible Relief | 12 hour-No onset subjects in hour | 6 subjects |
| Celecoxib 100mg (Pooled) | First Perceptible Relief | 8 hour - Onset subjects in hour | 0 subjects |
| Celecoxib 100mg (Pooled) | First Perceptible Relief | 8 hour-No onset subjects in hour | 8 subjects |
| Placebo | First Perceptible Relief | 1 hour - Onset subjects in hour | 29 subjects |
| Placebo | First Perceptible Relief | 1 hour - No onset subjects in hour | 16 subjects |
| Placebo | First Perceptible Relief | 2 hour - Onset subjects in hour | 10 subjects |
| Placebo | First Perceptible Relief | 8 hour-No onset subjects in hour | 3 subjects |
| Placebo | First Perceptible Relief | 2 hour-No onset subjects in hour | 6 subjects |
| Placebo | First Perceptible Relief | 6 hour-No onset subjects in hour | 3 subjects |
| Placebo | First Perceptible Relief | 7 hour - Onset subjects in hour | 0 subjects |
| Placebo | First Perceptible Relief | 3 hour - Onset subjects in hour | 2 subjects |
| Placebo | First Perceptible Relief | 7 hour-No onset subjects in hour | 3 subjects |
| Placebo | First Perceptible Relief | 3 hour-No onset subjects in hour | 4 subjects |
| Placebo | First Perceptible Relief | 4 hour - Onset subjects in hour | 0 subjects |
| Placebo | First Perceptible Relief | 4 hour- No onset subjects in hour | 4 subjects |
| Placebo | First Perceptible Relief | 8 hour - Onset subjects in hour | 0 subjects |
| Placebo | First Perceptible Relief | 5 hour - Onset subjects in hour | 0 subjects |
| Placebo | First Perceptible Relief | 9 hour-No onset subjects in hour | 3 subjects |
| Placebo | First Perceptible Relief | 10 hour - Onset subjects in hour | 0 subjects |
| Placebo | First Perceptible Relief | 12 hour - Onset subjects in hour | 0 subjects |
| Placebo | First Perceptible Relief | 10 hour-No onset subjects in hour | 3 subjects |
| Placebo | First Perceptible Relief | 12 hour-No onset subjects in hour | 3 subjects |
| Placebo | First Perceptible Relief | 5 hour-No onset subjects in hour | 4 subjects |
| Placebo | First Perceptible Relief | 11 hour-No onset subjects in hour ( | 3 subjects |
| Placebo | First Perceptible Relief | 11 hour - Onset subjects in hour | 0 subjects |
| Placebo | First Perceptible Relief | 24 hour - Onset subjects in hour | 0 subjects |
| Placebo | First Perceptible Relief | 9 hour - Onset subjects in hour | 0 subjects |
| Placebo | First Perceptible Relief | 24 hour-No onset subjects in hour | 3 subjects |
| Placebo | First Perceptible Relief | 6 hour - Onset subjects in hour | 1 subjects |
| Placebo | First Perceptible Relief | 8 hour - Onset subjects in hour | 1 subjects |
| Placebo | First Perceptible Relief | 24 hour-No onset subjects in hour | 6 subjects |
| Placebo | First Perceptible Relief | 1 hour - No onset subjects in hour | 23 subjects |
| Placebo | First Perceptible Relief | 6 hour-No onset subjects in hour | 8 subjects |
| Placebo | First Perceptible Relief | 1 hour - Onset subjects in hour | 22 subjects |
| Placebo | First Perceptible Relief | 5 hour-No onset subjects in hour | 11 subjects |
| Placebo | First Perceptible Relief | 9 hour-No onset subjects in hour | 6 subjects |
| Placebo | First Perceptible Relief | 7 hour - Onset subjects in hour | 1 subjects |
| Placebo | First Perceptible Relief | 2 hour-No onset subjects in hour | 14 subjects |
| Placebo | First Perceptible Relief | 5 hour - Onset subjects in hour | 1 subjects |
| Placebo | First Perceptible Relief | 24 hour - Onset subjects in hour | 0 subjects |
| Placebo | First Perceptible Relief | 10 hour - Onset subjects in hour | 0 subjects |
| Placebo | First Perceptible Relief | 3 hour - Onset subjects in hour | 0 subjects |
| Placebo | First Perceptible Relief | 9 hour - Onset subjects in hour | 0 subjects |
| Placebo | First Perceptible Relief | 6 hour - Onset subjects in hour | 3 subjects |
| Placebo | First Perceptible Relief | 11 hour-No onset subjects in hour ( | 6 subjects |
| Placebo | First Perceptible Relief | 3 hour-No onset subjects in hour | 14 subjects |
| Placebo | First Perceptible Relief | 7 hour-No onset subjects in hour | 7 subjects |
| Placebo | First Perceptible Relief | 8 hour-No onset subjects in hour | 6 subjects |
| Placebo | First Perceptible Relief | 11 hour - Onset subjects in hour | 0 subjects |
| Placebo | First Perceptible Relief | 4 hour - Onset subjects in hour | 2 subjects |
| Placebo | First Perceptible Relief | 2 hour - Onset subjects in hour | 9 subjects |
| Placebo | First Perceptible Relief | 12 hour-No onset subjects in hour | 6 subjects |
| Placebo | First Perceptible Relief | 10 hour-No onset subjects in hour | 6 subjects |
| Placebo | First Perceptible Relief | 4 hour- No onset subjects in hour | 12 subjects |
| Placebo | First Perceptible Relief | 12 hour - Onset subjects in hour | 0 subjects |
| Placebo | First Perceptible Relief | 24 hour-No onset subjects in hour | 18 subjects |
| Placebo | First Perceptible Relief | 1 hour - Onset subjects in hour | 40 subjects |
| Placebo | First Perceptible Relief | 2 hour - Onset subjects in hour | 11 subjects |
| Placebo | First Perceptible Relief | 6 hour - Onset subjects in hour | 1 subjects |
| Placebo | First Perceptible Relief | 9 hour - Onset subjects in hour | 2 subjects |
| Placebo | First Perceptible Relief | 11 hour-No onset subjects in hour ( | 21 subjects |
| Placebo | First Perceptible Relief | 12 hour - Onset subjects in hour | 1 subjects |
| Placebo | First Perceptible Relief | 7 hour - Onset subjects in hour | 1 subjects |
| Placebo | First Perceptible Relief | 11 hour - Onset subjects in hour | 1 subjects |
| Placebo | First Perceptible Relief | 1 hour - No onset subjects in hour | 49 subjects |
| Placebo | First Perceptible Relief | 2 hour-No onset subjects in hour | 38 subjects |
| Placebo | First Perceptible Relief | 3 hour - Onset subjects in hour | 2 subjects |
| Placebo | First Perceptible Relief | 3 hour-No onset subjects in hour | 36 subjects |
| Placebo | First Perceptible Relief | 4 hour - Onset subjects in hour | 4 subjects |
| Placebo | First Perceptible Relief | 4 hour- No onset subjects in hour | 32 subjects |
| Placebo | First Perceptible Relief | 5 hour - Onset subjects in hour | 4 subjects |
| Placebo | First Perceptible Relief | 5 hour-No onset subjects in hour | 28 subjects |
| Placebo | First Perceptible Relief | 6 hour-No onset subjects in hour | 27 subjects |
| Placebo | First Perceptible Relief | 7 hour-No onset subjects in hour | 26 subjects |
| Placebo | First Perceptible Relief | 8 hour - Onset subjects in hour | 2 subjects |
| Placebo | First Perceptible Relief | 8 hour-No onset subjects in hour | 24 subjects |
| Placebo | First Perceptible Relief | 9 hour-No onset subjects in hour | 22 subjects |
| Placebo | First Perceptible Relief | 10 hour - Onset subjects in hour | 0 subjects |
| Placebo | First Perceptible Relief | 10 hour-No onset subjects in hour | 22 subjects |
| Placebo | First Perceptible Relief | 12 hour-No onset subjects in hour | 20 subjects |
| Placebo | First Perceptible Relief | 24 hour - Onset subjects in hour | 2 subjects |
p-value: <0.001Mantel Haenszel
p-value: 0.002Mantel Haenszel
p-value: 0.235Mantel Haenszel
p-value: 0.012Mantel Haenszel
p-value: 0.438Mantel Haenszel
p-value: 0.067Mantel Haenszel
Other Pre-specified
Median Offset Time of No Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose
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.
Time frame: 24 Hours
Population: Number of subjects who achieved Meaningful Relief within 6 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Celecoxib 100mg (Pooled) | 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 |
| 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 |
| 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 |
| Placebo | Median Offset Time of No Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose | 10.00 hours |
Other Pre-specified
Median Onset Time of First Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose
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.
Time frame: 24 Hours
Population: Number of subjects who achieved meaningful relief within 6 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Celecoxib 100mg (Pooled) | 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 |
| Placebo | Median Onset Time of First Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose | 0.63 hours |
| Placebo | Median Onset Time of First Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose | 0.50 hours |
Other Pre-specified
No Perceptible Relief
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).
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib 100mg (Pooled) | No Perceptible Relief | 11 hour-No offset subjects in hr | 79 subjects |
| Celecoxib 100mg (Pooled) | No Perceptible Relief | 24 hour-Offset subjects in hour (N=78,37, 41, 81) | 3 subjects |
| Celecoxib 100mg (Pooled) | No Perceptible Relief | 7 hour- Offset subjects in hour | 4 subjects |
| Celecoxib 100mg (Pooled) | No Perceptible Relief | 1 hour-No offset subjects in hour | 90 subjects |
| Celecoxib 100mg (Pooled) | No Perceptible Relief | 10 hour-No offset subjects in hr | 80 subjects |
| Celecoxib 100mg (Pooled) | No Perceptible Relief | 7 hour-No offset subjects in hr | 84 subjects |
| Celecoxib 100mg (Pooled) | No Perceptible Relief | 8 hour- Offset subjects in hour | 1 subjects |
| Celecoxib 100mg (Pooled) | No Perceptible Relief | 9 hour-No offset subjects in hr | 82 subjects |
| Celecoxib 100mg (Pooled) | No Perceptible Relief | 8 hour-No offset subjects in hr | 83 subjects |
| Celecoxib 100mg (Pooled) | No Perceptible Relief | 24 hour-No offset subjects in hr (N=78,37,41, 81) | 75 subjects |
| Celecoxib 100mg (Pooled) | No Perceptible Relief | 9 hour- Offset subjects in hour | 1 subjects |
| Celecoxib 100mg (Pooled) | No Perceptible Relief | 2 hour- Offset subjects in hour | 0 subjects |
| Celecoxib 100mg (Pooled) | No Perceptible Relief | 5 hour- Offset subjects in hour | 1 subjects |
| Celecoxib 100mg (Pooled) | No Perceptible Relief | 12 hour-No offset subjects in hr | 78 subjects |
| Celecoxib 100mg (Pooled) | No Perceptible Relief | 2 hour-No offset subjects in hr | 90 subjects |
| Celecoxib 100mg (Pooled) | No Perceptible Relief | 10 hour-Offset subjects in hour | 2 subjects |
| Celecoxib 100mg (Pooled) | No Perceptible Relief | 3 hour- Offset subjects in hour | 1 subjects |
| Celecoxib 100mg (Pooled) | No Perceptible Relief | 12 hour-Offset subjects in hour | 1 subjects |
| Celecoxib 100mg (Pooled) | No Perceptible Relief | 3 hour-No offset subjects in hr | 89 subjects |
| Celecoxib 100mg (Pooled) | No Perceptible Relief | 4 hour- Offset subjects in hour | 0 subjects |
| Celecoxib 100mg (Pooled) | No Perceptible Relief | 4 hour-No offset subjects in hr | 89 subjects |
| Celecoxib 100mg (Pooled) | No Perceptible Relief | 1 hour - Offset subjects in hour | 0 subjects |
| Celecoxib 100mg (Pooled) | No Perceptible Relief | 5 hour-No offset subjects in hr | 88 subjects |
| Celecoxib 100mg (Pooled) | No Perceptible Relief | 6 hour- Offset subjects in hour | 0 subjects |
| Celecoxib 100mg (Pooled) | No Perceptible Relief | 11 hour-Offset subjects in hour | 1 subjects |
| Celecoxib 100mg (Pooled) | No Perceptible Relief | 6 hour-No offset subjects in hr | 88 subjects |
| Placebo | No Perceptible Relief | 4 hour-No offset subjects in hr | 44 subjects |
| Placebo | No Perceptible Relief | 12 hour-Offset subjects in hour | 0 subjects |
| Placebo | No Perceptible Relief | 10 hour-No offset subjects in hr | 37 subjects |
| Placebo | No Perceptible Relief | 5 hour- Offset subjects in hour | 0 subjects |
| Placebo | No Perceptible Relief | 7 hour- Offset subjects in hour | 2 subjects |
| Placebo | No Perceptible Relief | 3 hour- Offset subjects in hour | 0 subjects |
| Placebo | No Perceptible Relief | 10 hour-Offset subjects in hour | 0 subjects |
| Placebo | No Perceptible Relief | 6 hour- Offset subjects in hour | 0 subjects |
| Placebo | No Perceptible Relief | 7 hour-No offset subjects in hr | 42 subjects |
| Placebo | No Perceptible Relief | 1 hour-No offset subjects in hour | 45 subjects |
| Placebo | No Perceptible Relief | 9 hour-No offset subjects in hr | 37 subjects |
| Placebo | No Perceptible Relief | 5 hour-No offset subjects in hr | 44 subjects |
| Placebo | No Perceptible Relief | 8 hour- Offset subjects in hour | 2 subjects |
| Placebo | No Perceptible Relief | 3 hour-No offset subjects in hr | 44 subjects |
| Placebo | No Perceptible Relief | 9 hour- Offset subjects in hour | 3 subjects |
| Placebo | No Perceptible Relief | 24 hour-No offset subjects in hr (N=78,37,41, 81) | 37 subjects |
| Placebo | No Perceptible Relief | 8 hour-No offset subjects in hr | 40 subjects |
| Placebo | No Perceptible Relief | 11 hour-No offset subjects in hr | 37 subjects |
| Placebo | No Perceptible Relief | 1 hour - Offset subjects in hour | 0 subjects |
| Placebo | No Perceptible Relief | 12 hour-No offset subjects in hr | 37 subjects |
| Placebo | No Perceptible Relief | 4 hour- Offset subjects in hour | 0 subjects |
| Placebo | No Perceptible Relief | 2 hour- Offset subjects in hour | 1 subjects |
| Placebo | No Perceptible Relief | 24 hour-Offset subjects in hour (N=78,37, 41, 81) | 0 subjects |
| Placebo | No Perceptible Relief | 6 hour-No offset subjects in hr | 44 subjects |
| Placebo | No Perceptible Relief | 11 hour-Offset subjects in hour | 0 subjects |
| Placebo | No Perceptible Relief | 2 hour-No offset subjects in hr | 44 subjects |
| Placebo | No Perceptible Relief | 8 hour- Offset subjects in hour | 0 subjects |
| Placebo | No Perceptible Relief | 5 hour- Offset subjects in hour | 0 subjects |
| Placebo | No Perceptible Relief | 9 hour- Offset subjects in hour | 1 subjects |
| Placebo | No Perceptible Relief | 24 hour-No offset subjects in hr (N=78,37,41, 81) | 38 subjects |
| Placebo | No Perceptible Relief | 10 hour-Offset subjects in hour | 0 subjects |
| Placebo | No Perceptible Relief | 1 hour - Offset subjects in hour | 0 subjects |
| Placebo | No Perceptible Relief | 1 hour-No offset subjects in hour | 45 subjects |
| Placebo | No Perceptible Relief | 2 hour- Offset subjects in hour | 0 subjects |
| Placebo | No Perceptible Relief | 2 hour-No offset subjects in hr | 45 subjects |
| Placebo | No Perceptible Relief | 3 hour- Offset subjects in hour | 1 subjects |
| Placebo | No Perceptible Relief | 3 hour-No offset subjects in hr | 44 subjects |
| Placebo | No Perceptible Relief | 4 hour- Offset subjects in hour | 0 subjects |
| Placebo | No Perceptible Relief | 4 hour-No offset subjects in hr | 44 subjects |
| Placebo | No Perceptible Relief | 5 hour-No offset subjects in hr | 44 subjects |
| Placebo | No Perceptible Relief | 6 hour- Offset subjects in hour | 0 subjects |
| Placebo | No Perceptible Relief | 6 hour-No offset subjects in hr | 44 subjects |
| Placebo | No Perceptible Relief | 7 hour- Offset subjects in hour | 2 subjects |
| Placebo | No Perceptible Relief | 7 hour-No offset subjects in hr | 42 subjects |
| Placebo | No Perceptible Relief | 8 hour-No offset subjects in hr | 42 subjects |
| Placebo | No Perceptible Relief | 9 hour-No offset subjects in hr | 41 subjects |
| Placebo | No Perceptible Relief | 10 hour-No offset subjects in hr | 41 subjects |
| Placebo | No Perceptible Relief | 11 hour-Offset subjects in hour | 0 subjects |
| Placebo | No Perceptible Relief | 11 hour-No offset subjects in hr | 41 subjects |
| Placebo | No Perceptible Relief | 12 hour-Offset subjects in hour | 0 subjects |
| Placebo | No Perceptible Relief | 12 hour-No offset subjects in hr | 41 subjects |
| Placebo | No Perceptible Relief | 24 hour-Offset subjects in hour (N=78,37, 41, 81) | 3 subjects |
| Placebo | No Perceptible Relief | 6 hour-No offset subjects in hr | 87 subjects |
| Placebo | No Perceptible Relief | 10 hour-Offset subjects in hour | 3 subjects |
| Placebo | No Perceptible Relief | 10 hour-No offset subjects in hr | 83 subjects |
| Placebo | No Perceptible Relief | 6 hour- Offset subjects in hour | 1 subjects |
| Placebo | No Perceptible Relief | 5 hour-No offset subjects in hr | 88 subjects |
| Placebo | No Perceptible Relief | 24 hour-No offset subjects in hr (N=78,37,41, 81) | 81 subjects |
| Placebo | No Perceptible Relief | 11 hour-Offset subjects in hour | 0 subjects |
| Placebo | No Perceptible Relief | 4 hour- Offset subjects in hour | 0 subjects |
| Placebo | No Perceptible Relief | 3 hour-No offset subjects in hr | 88 subjects |
| Placebo | No Perceptible Relief | 24 hour-Offset subjects in hour (N=78,37, 41, 81) | 0 subjects |
| Placebo | No Perceptible Relief | 11 hour-No offset subjects in hr | 83 subjects |
| Placebo | No Perceptible Relief | 3 hour- Offset subjects in hour | 0 subjects |
| Placebo | No Perceptible Relief | 2 hour-No offset subjects in hr | 88 subjects |
| Placebo | No Perceptible Relief | 9 hour- Offset subjects in hour | 0 subjects |
| Placebo | No Perceptible Relief | 12 hour-Offset subjects in hour | 2 subjects |
| Placebo | No Perceptible Relief | 2 hour- Offset subjects in hour | 1 subjects |
| Placebo | No Perceptible Relief | 1 hour-No offset subjects in hour | 89 subjects |
| Placebo | No Perceptible Relief | 5 hour- Offset subjects in hour | 0 subjects |
| Placebo | No Perceptible Relief | 12 hour-No offset subjects in hr | 81 subjects |
| Placebo | No Perceptible Relief | 8 hour-No offset subjects in hr | 86 subjects |
| Placebo | No Perceptible Relief | 8 hour- Offset subjects in hour | 0 subjects |
| Placebo | No Perceptible Relief | 4 hour-No offset subjects in hr | 88 subjects |
| Placebo | No Perceptible Relief | 7 hour-No offset subjects in hr | 86 subjects |
| Placebo | No Perceptible Relief | 1 hour - Offset subjects in hour | 0 subjects |
| Placebo | No Perceptible Relief | 9 hour-No offset subjects in hr | 86 subjects |
| Placebo | No Perceptible Relief | 7 hour- Offset subjects in hour | 1 subjects |
p-value: 0.128Mantel Haenszel
p-value: 0.123Mantel Haenszel
p-value: 0.266Mantel Haenszel
p-value: 0.849Mantel Haenszel
p-value: 0.828Mantel Haenszel
p-value: 0.741Mantel Haenszel
Other Pre-specified
Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose
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.
Time frame: 12 hours Post-First Dose
Population: MITT population Comparison Celecoxib 100mg/50mg - Placebo: the NNT value was non-estimable
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celecoxib 100mg (Pooled) | Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose | 18 subjects |
| Placebo | Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose | 12 subjects |
| Placebo | Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose | 8 subjects |
| Placebo | Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose | 6 subjects |
Comparison: NNT is the inverse of the absolute risk reduction at 12 hours95% CI: [4.3, 28.7]
Comparison: NNT is the inverse of the absolute risk reduction at 12 hours95% CI: [3, 16.7]
Other Pre-specified
Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose
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.
Time frame: 6 hours Post-First Dose
Population: MITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celecoxib 100mg (Pooled) | Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose | 18 subjects |
| Placebo | Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose | 19 subjects |
| Placebo | Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose | 7 subjects |
Comparison: NNT is the inverse of the absolute risk reduction at 6 hours95% CI: [4.5, 46.4]
Comparison: NNT is the inverse of the absolute risk reduction at 6 hours95% CI: [4.3, 32]
Other Pre-specified
Sore Throat Pain Intensity Difference (SPID2) as Measured by Throat Soreness Scale (TSS) at 2 Hours Post-First Dose
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.
Time frame: 2 hour period Post-First Dose
Population: MITT population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib 100mg (Pooled) | 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 |
| Placebo | Sore Throat Pain Intensity Difference (SPID2) as Measured by Throat Soreness Scale (TSS) at 2 Hours Post-First Dose | 2.0 units on a scale * hours | Standard Error 0.21 |
| Placebo | Sore Throat Pain Intensity Difference (SPID2) as Measured by Throat Soreness Scale (TSS) at 2 Hours Post-First Dose | 1.0 units on a scale * hours | Standard Error 0.21 |
p-value: <0.00195% CI: [0.8, 1.9]Generalized linear model
p-value: 0.00295% CI: [0.4, 1.5]Generalized linear model
p-value: 0.18695% CI: [-1, 0.2]Generalized linear model
Other Pre-specified
Subjects Taking Rescue Medication
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.
Time frame: Within 24 hours Post-First Dose
Population: MITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celecoxib 100mg (Pooled) | Subjects Taking Rescue Medication | 22 subjects |
| Placebo | Subjects Taking Rescue Medication | 15 subjects |
| Placebo | Subjects Taking Rescue Medication | 13 subjects |
| Placebo | Subjects Taking Rescue Medication | 39 subjects |
p-value: 0.007Regression, Logistic
p-value: 0.244Regression, Logistic
p-value: 0.096Regression, Logistic
p-value: 0.579Regression, Logistic
p-value: 0.277Regression, Logistic
p-value: 0.649Regression, Logistic
Other Pre-specified
Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose
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'.
Time frame: 12 hours Post-First Dose
Population: MITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib 100mg (Pooled) | Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose | Meaningful Relief - achieved | 44 subjects |
| Celecoxib 100mg (Pooled) | Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose | Meaningful Relief - not achieved | 46 subjects |
| Celecoxib 100mg (Pooled) | Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose | Much Improvement - achieved | 38 subjects |
| Celecoxib 100mg (Pooled) | Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose | Much Improvement - not achieved | 52 subjects |
| Placebo | Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose | Meaningful Relief - not achieved | 19 subjects |
| Placebo | Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose | Much Improvement - achieved | 22 subjects |
| Placebo | Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose | Much Improvement - not achieved | 23 subjects |
| Placebo | Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose | Meaningful Relief - achieved | 26 subjects |
| Placebo | Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose | Much Improvement - achieved | 12 subjects |
| Placebo | Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose | Meaningful Relief - not achieved | 24 subjects |
| Placebo | Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose | Much Improvement - not achieved | 32 subjects |
| Placebo | Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose | Meaningful Relief - achieved | 20 subjects |
| Placebo | Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose | Much Improvement - not achieved | 73 subjects |
| Placebo | Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose | Meaningful Relief - not achieved | 69 subjects |
| Placebo | Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose | Meaningful Relief - achieved | 20 subjects |
| Placebo | Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose | Much Improvement - achieved | 16 subjects |
p-value: <0.001Regression, Logistic
p-value: <0.001Regression, Logistic
p-value: 0.008Regression, Logistic
p-value: 0.709Regression, Logistic
p-value: 0.331Regression, Logistic
p-value: 0.246Regression, Logistic
p-value: 0.001Regression, Logistic
p-value: <0.001Regression, Logistic
p-value: 0.219Regression, Logistic
p-value: 0.095Regression, Logistic
p-value: 0.463Regression, Logistic
p-value: 0.038Regression, Logistic
Other Pre-specified
Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 2 and 6 Hours Post-First Dose
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'.
Time frame: 2 and 6 hours Post-First Dose
Population: MITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| 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- not achieved | 63 subjects |
| 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 | 26 subjects |
| Placebo | 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 | 31 subjects |
| Placebo | 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 | 58 subjects |
| Placebo | 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 | 38 subjects |
| Placebo | 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 | 51 subjects |
| Placebo | 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 |
| Placebo | 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 | 67 subjects |
| Placebo | 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 | 77 subjects |
| 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 | 12 subjects |
| 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- not achieved | 77 subjects |
| Placebo | 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 | 17 subjects |
| Placebo | 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 | 72 subjects |
| Placebo | 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 | 10 subjects |
| Placebo | 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 | 79 subjects |
| Placebo | 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 | 12 subjects |
p-value: 0.001Regression, Logistic
p-value: 0.012Regression, Logistic
p-value: 0.453Regression, Logistic
p-value: <0.001Regression, Logistic
p-value: 0.001Regression, Logistic
p-value: 0.814Regression, Logistic
p-value: 0.024Regression, Logistic
p-value: 0.022Regression, Logistic
p-value: 0.966Regression, Logistic
p-value: 0.001Regression, Logistic
p-value: 0.001Regression, Logistic
p-value: 0.798Regression, Logistic
Other Pre-specified
Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Had Perceptible Relief Onset Time Within 1 Hour
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.
Time frame: Within 6 hours Post-First Dose
Population: MITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib 100mg (Pooled) | Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Had Perceptible Relief Onset Time Within 1 Hour | Achieved | 31 subjects |
| Celecoxib 100mg (Pooled) | 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 |
| Placebo | Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Had Perceptible Relief Onset Time Within 1 Hour | Achieved | 27 subjects |
| Placebo | Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Had Perceptible Relief Onset Time Within 1 Hour | Not achieved | 62 subjects |
| Placebo | Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Had Perceptible Relief Onset Time Within 1 Hour | Achieved | 12 subjects |
| Placebo | Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Had Perceptible Relief Onset Time Within 1 Hour | Not achieved | 77 subjects |
p-value: 0.001Regression, Logistic
p-value: 0.008Regression, Logistic
p-value: 0.557Regression, Logistic
Other Pre-specified
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 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
Time frame: 12 and 24 hours Post-First Dose
Population: MITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| 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 - Not Achieved | 29 subjects |
| 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 24 hours - Achieved | 16 subjects |
| 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 24 hours - Not Achieved | 29 subjects |
| 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 | 16 subjects |
| 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 24 hours - Achieved | 9 subjects |
| 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 | 12 subjects |
| 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 - Not Achieved | 32 subjects |
| 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 24 hours - Not Achieved | 35 subjects |
| 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 24 hours - Achieved | 11 subjects |
| 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 | 11 subjects |
| 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 24 hours - Not Achieved | 78 subjects |
| 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 - Not Achieved | 78 subjects |
p-value: <0.001Regression, Logistic
p-value: 0.002Regression, Logistic
p-value: 0.036Regression, Logistic
p-value: 0.339Regression, Logistic
p-value: 1Regression, Logistic
p-value: 0.401Regression, Logistic
p-value: 0.003Regression, Logistic
p-value: 0.002Regression, Logistic
p-value: 0.223Regression, Logistic
p-value: 0.198Regression, Logistic
p-value: 0.604Regression, Logistic
p-value: 0.117Regression, Logistic
Other Pre-specified
Subjects With >= 50% Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose
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.
Time frame: 12 hours Post-First Dose
Population: MITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celecoxib 100mg (Pooled) | Subjects With >= 50% Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose | 18 subjects |
| Placebo | Subjects With >= 50% Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose | 12 subjects |
| Placebo | Subjects With >= 50% Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose | 8 subjects |
| Placebo | Subjects With >= 50% Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose | 6 subjects |
p-value: 0.01395% CI: [1.3, 9.2]Regression, Logistic
p-value: 0.00395% CI: [1.7, 14.5]Regression, Logistic
p-value: 0.05795% CI: [1, 9.2]Regression, Logistic
p-value: 0.75895% CI: [0.5, 2.9]Regression, Logistic
p-value: 0.38195% CI: [0.3, 1.6]Regression, Logistic
p-value: 0.31395% CI: [0.6, 4.6]Regression, Logistic
Other Pre-specified
Subjects With >= 50% Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose
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.
Time frame: 6 hours Post-First Dose
Population: MITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celecoxib 100mg (Pooled) | Subjects With >= 50% Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose | 18 subjects |
| Placebo | Subjects With >= 50% Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose | 19 subjects |
| Placebo | Subjects With >= 50% Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose | 7 subjects |
p-value: 0.02395% CI: [1.2, 7.4]Regression, Logistic
p-value: 0.01595% CI: [1.2, 7.9]Regression, Logistic
p-value: 0.85495% CI: [0.5, 2.2]Regression, Logistic
Other Pre-specified
Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 12 Hours Post-First Dose
\>= 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.
Time frame: 12 hours Post-First Dose
Population: MITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| 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 | 13 subjects |
| Placebo | Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 12 Hours Post-First Dose | 12 hours >=50% gone | 12 subjects |
| Placebo | Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 12 Hours Post-First Dose | 12 hours >=50% gone | 10 subjects |
| 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 | 12 subjects |
| 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 | 13 subjects |
| Placebo | Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 12 Hours Post-First Dose | 12 hours >=50% gone | 9 subjects |
p-value: 0.00495% CI: [1.4, 6.1]Regression, Logistic
p-value: 0.05295% CI: [1, 5.7]Regression, Logistic
p-value: 0.09595% CI: [0.9, 5.1]Regression, Logistic
p-value: 0.43195% CI: [0.6, 3]Regression, Logistic
p-value: 0.60295% CI: [0.6, 2.7]Regression, Logistic
p-value: 0.81495% CI: [0.4, 2.8]Regression, Logistic
p-value: 0.01495% CI: [1.2, 6.7]Regression, Logistic
p-value: 0.01695% CI: [1.2, 8.4]Regression, Logistic
p-value: 0.06395% CI: [0.9, 6.8]Regression, Logistic
p-value: 0.77595% CI: [0.5, 2.7]Regression, Logistic
p-value: 0.77995% CI: [0.4, 2]Regression, Logistic
p-value: 0.62495% CI: [0.5, 3.3]Regression, Logistic
Other Pre-specified
Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 2 and 6 Hours Post-First Dose
\>= 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.
Time frame: 2 and 6 hours Post-First Dose
Population: MITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| 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 | 32 subjects |
| Placebo | 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 | 22 subjects |
| 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 >=50% gone | 24 subjects |
| Placebo | 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 | 29 subjects |
| Placebo | 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 | 9 subjects |
| 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 >=50% gone | 8 subjects |
| Placebo | 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 | 12 subjects |
| 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 | 15 subjects |
p-value: <0.00195% CI: [1.9, 7.6]Regression, Logistic
p-value: 0.00595% CI: [1.3, 5.5]Regression, Logistic
p-value: 0.28695% CI: [0.4, 1.3]Regression, Logistic
p-value: 0.00195% CI: [1.6, 7.1]Regression, Logistic
p-value: 0.00495% CI: [1.4, 6.5]Regression, Logistic
p-value: 0.75295% CI: [0.5, 1.7]Regression, Logistic
p-value: <0.00195% CI: [1.9, 10.7]Regression, Logistic
p-value: 0.00395% CI: [1.6, 8.7]Regression, Logistic
p-value: 0.51195% CI: [0.4, 1.5]Regression, Logistic
p-value: 0.00995% CI: [1.3, 7]Regression, Logistic
p-value: 0.01495% CI: [1.2, 6.7]Regression, Logistic
p-value: 0.86395% CI: [0.5, 1.9]Regression, Logistic
Other Pre-specified
Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose
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.
Time frame: 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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 24 hours | 358.7 units on a scale * hours | Standard Error 71.3 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 8 hours | 151.3 units on a scale * hours | Standard Error 21.3 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 9 hours | 167.5 units on a scale * hours | Standard Error 24.2 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 11 hours | 195.8 units on a scale * hours | Standard Error 29.9 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 12 hours | 208.0 units on a scale * hours | Standard Error 32.8 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 7 hours | 133.6 units on a scale * hours | Standard Error 18.3 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 10 hours | 182.2 units on a scale * hours | Standard Error 27 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 7 hours | 72.2 units on a scale * hours | Standard Error 18.3 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 8 hours | 84.5 units on a scale * hours | Standard Error 21.3 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 12 hours | 135.4 units on a scale * hours | Standard Error 32.8 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 9 hours | 97.6 units on a scale * hours | Standard Error 24.2 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 10 hours | 109.8 units on a scale * hours | Standard Error 27 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 11 hours | 122.2 units on a scale * hours | Standard Error 29.9 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 24 hours | 295.3 units on a scale * hours | Standard Error 71.3 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 24 hours | 144.9 units on a scale * hours | Standard Error 50.7 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 11 hours | 55.1 units on a scale * hours | Standard Error 21.3 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 8 hours | 38.8 units on a scale * hours | Standard Error 15.1 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 7 hours | 33.9 units on a scale * hours | Standard Error 13 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 9 hours | 43.9 units on a scale * hours | Standard Error 17.2 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 12 hours | 60.4 units on a scale * hours | Standard Error 23.4 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose | 10 hours | 49.6 units on a scale * hours | Standard Error 19.2 |
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.09Generalized linear model
p-value: 0.518Generalized linear model
p-value: 0.038Generalized linear model
p-value: 0.019Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.081Generalized linear model
p-value: 0.552Generalized linear model
p-value: 0.05Generalized linear model
p-value: 0.027Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.071Generalized linear model
p-value: 0.609Generalized linear model
p-value: 0.065Generalized linear model
p-value: 0.042Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.07Generalized linear model
p-value: 0.689Generalized linear model
p-value: 0.075Generalized linear model
p-value: 0.059Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.069Generalized linear model
p-value: 0.762Generalized linear model
p-value: 0.089Generalized linear model
p-value: 0.083Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.064Generalized linear model
p-value: 0.841Generalized linear model
p-value: 0.11Generalized linear model
p-value: 0.119Generalized linear model
p-value: 0.001Generalized linear model
p-value: 0.015Generalized linear model
p-value: 0.087Generalized linear model
p-value: 0.826Generalized linear model
p-value: 0.345Generalized linear model
p-value: 0.53Generalized linear model
Other Pre-specified
Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose
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.
Time frame: 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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 75 min | 5.8 units on a scale * hours | Standard Error 1.4 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 60 min | 3.5 units on a scale * hours | Standard Error 1 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 1.75 hours | 12.1 units on a scale * hours | Standard Error 2.2 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 15 min | 0.1 units on a scale * hours | Standard Error 0.1 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 30 min | 0.7 units on a scale * hours | Standard Error 0.3 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 45 min | 1.8 units on a scale * hours | Standard Error 0.6 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 90 min | 8.7 units on a scale * hours | Standard Error 1.8 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 2 hours | 16.0 units on a scale * hours | Standard Error 2.7 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 3 hours | 33.5 units on a scale * hours | Standard Error 4.8 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 4 hours | 51.8 units on a scale * hours | Standard Error 6.8 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 5 hours | 70.0 units on a scale * hours | Standard Error 9 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 6 hours | 87.3 units on a scale * hours | Standard Error 11 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 6 hours | 28.6 units on a scale * hours | Standard Error 11.1 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 15 min | 0.1 units on a scale * hours | Standard Error 0.1 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 5 hours | 22.8 units on a scale * hours | Standard Error 9 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 3 hours | 10.4 units on a scale * hours | Standard Error 4.8 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 1.75 hours | 4.6 units on a scale * hours | Standard Error 2.3 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 4 hours | 16.1 units on a scale * hours | Standard Error 6.9 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 60 min | 1.6 units on a scale * hours | Standard Error 1 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 75 min | 2.6 units on a scale * hours | Standard Error 1.4 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 45 min | 0.8 units on a scale * hours | Standard Error 0.6 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 2 hours | 5.8 units on a scale * hours | Standard Error 2.8 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 90 min | 3.6 units on a scale * hours | Standard Error 1.8 |
| Placebo | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose | 30 min | 0.3 units on a scale * hours | Standard Error 0.3 |
p-value: 0.48Generalized linear model
p-value: 0.78Generalized linear model
p-value: 0.667Generalized linear model
p-value: 0.153Generalized linear model
p-value: 0.479Generalized linear model
p-value: 0.469Generalized linear model
p-value: 0.062Generalized linear model
p-value: 0.284Generalized linear model
p-value: 0.421Generalized linear model
p-value: 0.022Generalized linear model
p-value: 0.171Generalized linear model
p-value: 0.354Generalized linear model
p-value: 0.005Generalized linear model
p-value: 0.09Generalized linear model
p-value: 0.262Generalized linear model
p-value: 0.001Generalized linear model
p-value: 0.044Generalized linear model
p-value: 0.194Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.02Generalized linear model
p-value: 0.148Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.009Generalized linear model
p-value: 0.127Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.001Generalized linear model
p-value: 0.122Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.164Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.244Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.336Generalized linear model
Other Pre-specified
Sum of Sore Throat Pain Intensity Difference (SPID2) as Measured by Difficulty Swallowing Scale (DSS) at 2 Hours Post-First Dose
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.
Time frame: Over 2 hour Period Post-First Dose
Population: MITT population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib 100mg (Pooled) | 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 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID2) as Measured by Difficulty Swallowing Scale (DSS) at 2 Hours Post-First Dose | 16.0 units on a scale * hours | Standard Error 2.73 |
| Placebo | Sum of Sore Throat Pain Intensity Difference (SPID2) as Measured by Difficulty Swallowing Scale (DSS) at 2 Hours Post-First Dose | 5.8 units on a scale * hours | Standard Error 2.75 |
p-value: <0.00195% CI: [8.5, 23.8]Generalized linear model
p-value: 0.00995% CI: [2.6, 17.9]Generalized linear model
p-value: 0.12795% CI: [-13.5, 1.7]Generalized linear model
Other Pre-specified
Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose
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.
Time frame: 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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose | 9 hours | 17.7 units on a scale * hours | Standard Error 2.1 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose | 7 hours | 14.2 units on a scale * hours | Standard Error 1.6 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose | 11 hours | 20.8 units on a scale * hours | Standard Error 2.6 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose | 24 hours | 39.2 units on a scale * hours | Standard Error 6.4 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose | 8 hours | 16.0 units on a scale * hours | Standard Error 1.8 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose | 10 hours | 19.3 units on a scale * hours | Standard Error 2.4 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose | 12 hours | 22.3 units on a scale * hours | Standard Error 2.9 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose | 11 hours | 16.6 units on a scale * hours | Standard Error 2.6 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose | 7 hours | 9.9 units on a scale * hours | Standard Error 1.6 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose | 24 hours | 39.8 units on a scale * hours | Standard Error 6.4 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose | 12 hours | 18.4 units on a scale * hours | Standard Error 2.9 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose | 10 hours | 14.9 units on a scale * hours | Standard Error 2.3 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose | 9 hours | 13.3 units on a scale * hours | Standard Error 2.1 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose | 8 hours | 11.6 units on a scale * hours | Standard Error 1.8 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose | 11 hours | 8.9 units on a scale * hours | Standard Error 1.9 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose | 9 hours | 7.2 units on a scale * hours | Standard Error 1.5 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose | 10 hours | 8.1 units on a scale * hours | Standard Error 1.7 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose | 7 hours | 5.6 units on a scale * hours | Standard Error 1.1 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose | 24 hours | 21.7 units on a scale * hours | Standard Error 4.6 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose | 12 hours | 9.8 units on a scale * hours | Standard Error 2.1 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose | 8 hours | 6.3 units on a scale * hours | Standard Error 1.3 |
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.026Generalized linear model
p-value: 0.463Generalized linear model
p-value: 0.131Generalized linear model
p-value: 0.053Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.02Generalized linear model
p-value: 0.484Generalized linear model
p-value: 0.197Generalized linear model
p-value: 0.086Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.018Generalized linear model
p-value: 0.561Generalized linear model
p-value: 0.252Generalized linear model
p-value: 0.136Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.018Generalized linear model
p-value: 0.653Generalized linear model
p-value: 0.287Generalized linear model
p-value: 0.191Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.018Generalized linear model
p-value: 0.741Generalized linear model
p-value: 0.326Generalized linear model
p-value: 0.256Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.001Generalized linear model
p-value: 0.016Generalized linear model
p-value: 0.808Generalized linear model
p-value: 0.394Generalized linear model
p-value: 0.343Generalized linear model
p-value: 0.005Generalized linear model
p-value: 0.029Generalized linear model
p-value: 0.023Generalized linear model
p-value: 0.892Generalized linear model
p-value: 0.952Generalized linear model
p-value: 0.948Generalized linear model
Other Pre-specified
Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose
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.
Time frame: 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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose | 60 min | 0.39 units on a scale * hours | Standard Error 0.06 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose | 3 hours | 4.02 units on a scale * hours | Standard Error 0.39 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose | 4 hours | 6.12 units on a scale * hours | Standard Error 0.58 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose | 45 min | 0.19 units on a scale * hours | Standard Error 0.03 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose | 5 hours | 8.21 units on a scale * hours | Standard Error 0.77 |
| Placebo | 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 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose | 6 hours | 10.20 units on a scale * hours | Standard Error 0.94 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose | 2 hours | 1.96 units on a scale * hours | Standard Error 0.21 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose | 75 min | 0.67 units on a scale * hours | Standard Error 0.09 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose | 90 min | 1.04 units on a scale * hours | Standard Error 0.13 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose | 30 min | 0.06 units on a scale * hours | Standard Error 0.02 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose | 1.75 hours | 1.48 units on a scale * hours | Standard Error 0.16 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose | 6 hours | 4.75 units on a scale * hours | Standard Error 0.95 |
| Placebo | 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 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose | 30 min | 0.05 units on a scale * hours | Standard Error 0.02 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose | 45 min | 0.14 units on a scale * hours | Standard Error 0.04 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose | 60 min | 0.27 units on a scale * hours | Standard Error 0.06 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose | 75 min | 0.44 units on a scale * hours | Standard Error 0.09 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose | 90 min | 0.63 units on a scale * hours | Standard Error 0.13 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose | 1.75 hours | 0.82 units on a scale * hours | Standard Error 0.17 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose | 3 hours | 1.83 units on a scale * hours | Standard Error 0.39 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose | 4 hours | 2.76 units on a scale * hours | Standard Error 0.59 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose | 5 hours | 3.79 units on a scale * hours | Standard Error 0.77 |
| Placebo | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose | 2 hours | 1.02 units on a scale * hours | Standard Error 0.21 |
p-value: 0.961Generalized linear model
p-value: 0.985Generalized linear model
p-value: 0.975Generalized linear model
p-value: 0.532Generalized linear model
p-value: 0.69Generalized linear model
p-value: 0.82Generalized linear model
p-value: 0.18Generalized linear model
p-value: 0.344Generalized linear model
p-value: 0.693Generalized linear model
p-value: 0.039Generalized linear model
p-value: 0.154Generalized linear model
p-value: 0.521Generalized linear model
p-value: 0.006Generalized linear model
p-value: 0.07Generalized linear model
p-value: 0.344Generalized linear model
p-value: 0.001Generalized linear model
p-value: 0.022Generalized linear model
p-value: 0.249Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.006Generalized linear model
p-value: 0.205Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.002Generalized linear model
p-value: 0.186Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.179Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.259Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.393Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.512Generalized linear model
Other Pre-specified
Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose
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.
Time frame: 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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Celecoxib 100mg (Pooled) | 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 |
| Placebo | Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose | 12 hours | 1.37 scores on a scale | Standard Error 0.33 |
| Placebo | Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose | 10 hours | 1.58 scores on a scale | Standard Error 0.33 |
| Placebo | Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose | 9 hours | 1.60 scores on a scale | Standard Error 0.32 |
| Placebo | Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose | 11 hours | 1.53 scores on a scale | Standard Error 0.32 |
| Placebo | Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose | 24 hours | 1.46 scores on a scale | Standard Error 0.36 |
| Placebo | Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose | 8 hours | 1.65 scores on a scale | Standard Error 0.3 |
| Placebo | Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose | 7 hours | 1.95 scores on a scale | Standard Error 0.3 |
| Placebo | Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose | 10 hours | 1.63 scores on a scale | Standard Error 0.32 |
| Placebo | Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose | 7 hours | 1.68 scores on a scale | Standard Error 0.29 |
| Placebo | Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose | 8 hours | 1.70 scores on a scale | Standard Error 0.3 |
| Placebo | Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose | 9 hours | 1.65 scores on a scale | Standard Error 0.32 |
| Placebo | Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose | 11 hours | 1.76 scores on a scale | Standard Error 0.32 |
| Placebo | Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose | 12 hours | 1.80 scores on a scale | Standard Error 0.33 |
| Placebo | Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose | 24 hours | 1.78 scores on a scale | Standard Error 0.35 |
| Placebo | Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose | 9 hours | 0.90 scores on a scale | Standard Error 0.23 |
| Placebo | Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose | 24 hours | 1.17 scores on a scale | Standard Error 0.25 |
| Placebo | Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose | 12 hours | 0.82 scores on a scale | Standard Error 0.24 |
| Placebo | Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose | 8 hours | 0.76 scores on a scale | Standard Error 0.22 |
| Placebo | Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose | 7 hours | 0.78 scores on a scale | Standard Error 0.21 |
| Placebo | Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose | 11 hours | 0.87 scores on a scale | Standard Error 0.23 |
| Placebo | Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose | 10 hours | 0.87 scores on a scale | Standard Error 0.23 |
p-value: 0.003Generalized linear model
p-value: 0.009Generalized linear model
p-value: 0.043Generalized linear model
p-value: 0.032Generalized linear model
p-value: 0.029Generalized linear model
p-value: 0.066Generalized linear model
p-value: 0.482Generalized linear model
Other Pre-specified
Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose
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.
Time frame: 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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 100mg (Pooled) | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 60 min | 1.17 scores on a scale | Standard Error 0.13 |
| Celecoxib 100mg (Pooled) | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 15 min | 0.06 scores on a scale | Standard Error 0.04 |
| Celecoxib 100mg (Pooled) | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 30 min | 0.39 scores on a scale | Standard Error 0.08 |
| Celecoxib 100mg (Pooled) | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 45 min | 0.74 scores on a scale | Standard Error 0.1 |
| Celecoxib 100mg (Pooled) | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 75 min | 1.62 scores on a scale | Standard Error 0.15 |
| Celecoxib 100mg (Pooled) | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 90 min | 1.97 scores on a scale | Standard Error 0.17 |
| Celecoxib 100mg (Pooled) | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 1.75 hours | 2.24 scores on a scale | Standard Error 0.18 |
| Celecoxib 100mg (Pooled) | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 2 hours | 2.39 scores on a scale | Standard Error 0.19 |
| Celecoxib 100mg (Pooled) | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 3 hours | 2.43 scores on a scale | Standard Error 0.2 |
| Celecoxib 100mg (Pooled) | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 4 hours | 2.14 scores on a scale | Standard Error 0.21 |
| Celecoxib 100mg (Pooled) | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 5 hours | 2.03 scores on a scale | Standard Error 0.2 |
| Celecoxib 100mg (Pooled) | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 6 hours | 1.83 scores on a scale | Standard Error 0.2 |
| Placebo | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 6 hours | 1.90 scores on a scale | Standard Error 0.2 |
| Placebo | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 60 min | 0.97 scores on a scale | Standard Error 0.13 |
| Placebo | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 3 hours | 2.09 scores on a scale | Standard Error 0.2 |
| Placebo | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 15 min | 0.06 scores on a scale | Standard Error 0.04 |
| Placebo | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 1.75 hours | 1.86 scores on a scale | Standard Error 0.18 |
| Placebo | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 90 min | 1.64 scores on a scale | Standard Error 0.17 |
| Placebo | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 30 min | 0.36 scores on a scale | Standard Error 0.08 |
| Placebo | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 5 hours | 2.06 scores on a scale | Standard Error 0.21 |
| Placebo | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 2 hours | 2.03 scores on a scale | Standard Error 0.19 |
| Placebo | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 45 min | 0.66 scores on a scale | Standard Error 0.1 |
| Placebo | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 75 min | 1.29 scores on a scale | Standard Error 0.15 |
| Placebo | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 4 hours | 2.12 scores on a scale | Standard Error 0.21 |
| Placebo | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 60 min | 0.60 scores on a scale | Standard Error 0.13 |
| Placebo | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 75 min | 0.75 scores on a scale | Standard Error 0.15 |
| Placebo | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 4 hours | 1.01 scores on a scale | Standard Error 0.21 |
| Placebo | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 90 min | 0.76 scores on a scale | Standard Error 0.17 |
| Placebo | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 1.75 hours | 0.79 scores on a scale | Standard Error 0.19 |
| Placebo | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 2 hours | 0.78 scores on a scale | Standard Error 0.19 |
| Placebo | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 5 hours | 1.04 scores on a scale | Standard Error 0.21 |
| Placebo | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 15 min | 0.06 scores on a scale | Standard Error 0.04 |
| Placebo | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 3 hours | 0.85 scores on a scale | Standard Error 0.21 |
| Placebo | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 30 min | 0.29 scores on a scale | Standard Error 0.08 |
| Placebo | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 6 hours | 0.90 scores on a scale | Standard Error 0.21 |
| Placebo | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose | 45 min | 0.43 scores on a scale | Standard Error 0.1 |
p-value: 0.999Generalized linear model
p-value: 0.609Generalized linear model
p-value: 0.076Generalized linear model
p-value: 0.008Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: <0.001Generalized linear model
p-value: 0.001Generalized linear model
Other Pre-specified
Total Pain Relief (TOTPAR) at 12 and 24 Hours Post-First Dose
TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief).
Time frame: 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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 100mg (Pooled) | Total Pain Relief (TOTPAR) at 12 and 24 Hours Post-First Dose | 24 hours | 40.9 scores on a scale | Standard Error 3.6 |
| Celecoxib 100mg (Pooled) | Total Pain Relief (TOTPAR) at 12 and 24 Hours Post-First Dose | 12 hours | 20.6 scores on a scale | Standard Error 1.7 |
| Placebo | Total Pain Relief (TOTPAR) at 12 and 24 Hours Post-First Dose | 12 hours | 22.0 scores on a scale | Standard Error 2.4 |
| Placebo | Total Pain Relief (TOTPAR) at 12 and 24 Hours Post-First Dose | 24 hours | 41.5 scores on a scale | Standard Error 5.1 |
| Placebo | Total Pain Relief (TOTPAR) at 12 and 24 Hours Post-First Dose | 12 hours | 17.5 scores on a scale | Standard Error 2.4 |
| Placebo | Total Pain Relief (TOTPAR) at 12 and 24 Hours Post-First Dose | 24 hours | 36.7 scores on a scale | Standard Error 5.1 |
| Placebo | Total Pain Relief (TOTPAR) at 12 and 24 Hours Post-First Dose | 24 hours | 27.3 scores on a scale | Standard Error 3.7 |
| Placebo | Total Pain Relief (TOTPAR) at 12 and 24 Hours Post-First Dose | 12 hours | 11.6 scores on a scale | Standard Error 1.7 |
p-value: <0.00195% CI: [4.4, 13.7]Generalized linear model
p-value: <0.00195% CI: [4.7, 16.2]Generalized linear model
p-value: 0.04195% CI: [0.2, 11.7]Generalized linear model
p-value: 0.63395% CI: [-7.1, 4.3]Generalized linear model
p-value: 0.28495% CI: [-2.6, 8.8]Generalized linear model
p-value: 0.1895% CI: [-2.1, 11.1]Generalized linear model
p-value: 0.00995% CI: [3.4, 23.7]Generalized linear model
p-value: 0.02695% CI: [1.7, 26.6]Generalized linear model
p-value: 0.13895% CI: [-3, 21.8]Generalized linear model
p-value: 0.92695% CI: [-13, 11.8]Generalized linear model
p-value: 0.50795% CI: [-8.2, 16.6]Generalized linear model
p-value: 0.51395% CI: [-9.6, 19.1]Generalized linear model
Other Pre-specified
Total Pain Relief (TOTPAR) at 2 and 6 Hours Post-First Dose
TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief).
Time frame: 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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 100mg (Pooled) | Total Pain Relief (TOTPAR) at 2 and 6 Hours Post-First Dose | 2 hours | 2.6 scores on a scale | Standard Error 0.2 |
| Celecoxib 100mg (Pooled) | Total Pain Relief (TOTPAR) at 2 and 6 Hours Post-First Dose | 6 hours | 10.6 scores on a scale | Standard Error 0.8 |
| Placebo | Total Pain Relief (TOTPAR) at 2 and 6 Hours Post-First Dose | 2 hours | 2.2 scores on a scale | Standard Error 0.2 |
| Placebo | Total Pain Relief (TOTPAR) at 2 and 6 Hours Post-First Dose | 6 hours | 9.9 scores on a scale | Standard Error 0.8 |
| Placebo | Total Pain Relief (TOTPAR) at 2 and 6 Hours Post-First Dose | 2 hours | 1.3 scores on a scale | Standard Error 0.2 |
| Placebo | Total Pain Relief (TOTPAR) at 2 and 6 Hours Post-First Dose | 6 hours | 5.3 scores on a scale | Standard Error 0.8 |
p-value: <0.00195% CI: [0.7, 1.9]Generalized linear model
p-value: 0.00395% CI: [0.3, 1.5]Generalized linear model
p-value: 0.17795% CI: [-1, 0.2]Generalized linear model
p-value: <0.00195% CI: [3, 7.5]Generalized linear model
p-value: <0.00195% CI: [2.3, 6.8]Generalized linear model
p-value: 0.53195% CI: [-3, 1.5]Generalized linear model
Other Pre-specified
Treatment Failures on STRRS Questionnaire
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.
Time frame: 24 hours Post-First Dose
Population: MITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib 100mg (Pooled) | Treatment Failures on STRRS Questionnaire | Treatment failures | 44 subjects |
| Celecoxib 100mg (Pooled) | Treatment Failures on STRRS Questionnaire | Not treatment failures | 46 subjects |
| Placebo | Treatment Failures on STRRS Questionnaire | Not treatment failures | 27 subjects |
| Placebo | Treatment Failures on STRRS Questionnaire | Treatment failures | 18 subjects |
| Placebo | Treatment Failures on STRRS Questionnaire | Treatment failures | 24 subjects |
| Placebo | Treatment Failures on STRRS Questionnaire | Not treatment failures | 20 subjects |
| Placebo | Treatment Failures on STRRS Questionnaire | Treatment failures | 66 subjects |
| Placebo | Treatment Failures on STRRS Questionnaire | Not treatment failures | 23 subjects |
p-value: 0.001Regression, Logistic
p-value: <0.001Regression, Logistic
p-value: 0.025Regression, Logistic
p-value: 0.539Regression, Logistic
p-value: 0.329Regression, Logistic
p-value: 0.171Regression, Logistic
Other Pre-specified
Treatment Satisfaction Questionnaire for Medication (TSQM vII)
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.
Time frame: 24 hours or immediately prior to taking rescue medication
Population: MITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 100mg (Pooled) | Treatment Satisfaction Questionnaire for Medication (TSQM vII) | Effectiveness | 41.5 scores on a scale | Standard Deviation 26.6 |
| Celecoxib 100mg (Pooled) | Treatment Satisfaction Questionnaire for Medication (TSQM vII) | Side Effects | 96.3 scores on a scale | Standard Deviation 12 |
| Celecoxib 100mg (Pooled) | Treatment Satisfaction Questionnaire for Medication (TSQM vII) | Convenience | 77.2 scores on a scale | Standard Deviation 15.1 |
| Celecoxib 100mg (Pooled) | Treatment Satisfaction Questionnaire for Medication (TSQM vII) | Global Satisfaction | 49.1 scores on a scale | Standard Deviation 28 |
| Placebo | Treatment Satisfaction Questionnaire for Medication (TSQM vII) | Side Effects | 96.7 scores on a scale | Standard Deviation 11.6 |
| Placebo | Treatment Satisfaction Questionnaire for Medication (TSQM vII) | Convenience | 73.0 scores on a scale | Standard Deviation 17.4 |
| Placebo | Treatment Satisfaction Questionnaire for Medication (TSQM vII) | Global Satisfaction | 47.8 scores on a scale | Standard Deviation 33.4 |
| Placebo | Treatment Satisfaction Questionnaire for Medication (TSQM vII) | Effectiveness | 40.6 scores on a scale | Standard Deviation 28.7 |
| Placebo | Treatment Satisfaction Questionnaire for Medication (TSQM vII) | Convenience | 69.3 scores on a scale | Standard Deviation 16.8 |
| Placebo | Treatment Satisfaction Questionnaire for Medication (TSQM vII) | Side Effects | 97.9 scores on a scale | Standard Deviation 9.7 |
| Placebo | Treatment Satisfaction Questionnaire for Medication (TSQM vII) | Global Satisfaction | 42.2 scores on a scale | Standard Deviation 30.6 |
| Placebo | Treatment Satisfaction Questionnaire for Medication (TSQM vII) | Effectiveness | 34.3 scores on a scale | Standard Deviation 26.2 |
| Placebo | Treatment Satisfaction Questionnaire for Medication (TSQM vII) | Global Satisfaction | 36.0 scores on a scale | Standard Deviation 27.3 |
| Placebo | Treatment Satisfaction Questionnaire for Medication (TSQM vII) | Side Effects | 98.6 scores on a scale | Standard Deviation 8.2 |
| Placebo | Treatment Satisfaction Questionnaire for Medication (TSQM vII) | Effectiveness | 26.1 scores on a scale | Standard Deviation 25.4 |
| Placebo | Treatment Satisfaction Questionnaire for Medication (TSQM vII) | Convenience | 71.3 scores on a scale | Standard Deviation 14.6 |
p-value: 0.37195% CI: [-6.6, 17.7]Generalized linear model
p-value: <0.00195% CI: [7.5, 23.2]Generalized linear model
p-value: 0.00395% CI: [4.9, 24]Generalized linear model
p-value: 0.09695% CI: [-1.5, 17.8]Generalized linear model
p-value: 0.14195% CI: [-2.4, 16.8]Generalized linear model
p-value: 0.84995% CI: [-8.6, 10.5]Generalized linear model
p-value: 0.26695% CI: [-4.8, 17.4]Generalized linear model
p-value: 0.14195% CI: [-5.4, 0.8]Generalized linear model
p-value: 0.31295% CI: [-5.7, 1.8]Generalized linear model
p-value: 0.72495% CI: [-4.5, 3.1]Generalized linear model
p-value: 0.39895% CI: [-5.4, 2.1]Generalized linear model
p-value: 0.84695% CI: [-4.1, 3.4]Generalized linear model
p-value: 0.57295% CI: [-5.6, 3.1]Generalized linear model
p-value: 0.01495% CI: [1.2, 10.4]Generalized linear model
p-value: 0.57395% CI: [-4, 7.2]Generalized linear model
p-value: 0.48295% CI: [-7.7, 3.6]Generalized linear model
p-value: 0.00795% CI: [2.2, 13.5]Generalized linear model
p-value: 0.14395% CI: [-1.4, 9.8]Generalized linear model
p-value: 0.27395% CI: [-2.9, 10.2]Generalized linear model
p-value: 0.00395% CI: [4.4, 21.6]Generalized linear model
p-value: 0.02995% CI: [1.2, 22.2]Generalized linear model
p-value: 0.25195% CI: [-4.4, 16.8]Generalized linear model
p-value: 0.20495% CI: [-3.7, 17.4]Generalized linear model
p-value: 0.80895% CI: [-9.2, 11.8]Generalized linear model