Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00402987
Collaborator
(none)
269
1
4
11.4
23.7
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
269 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED COMPARISON OF THE EFFICACY, SAFETY, AND TOLERABILITY OF CELECOXIB 100-150 MG, INCLUDING INITIAL DOSES OF 50 AND 100 MG, AND PLACEBO IN THE SYMPTOMATIC TREATMENT OF PATIENTS WITH PAINFUL PHARYNGITIS
Actual Study Start Date
:
Dec 4, 2006
Actual Primary Completion Date
:
Nov 15, 2007
Actual Study Completion Date
:
Nov 15, 2007
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: celecoxib 50 mg/50 mg
|
Drug: Celecoxib
dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
|
| Experimental: celecoxib 100 mg/placebo
|
Drug: Celecoxib
dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
|
| Experimental: celecoxib 100 mg/50 mg
|
Drug: celecoxib
dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
|
| Placebo Comparator: Placebo
|
Drug: placebo
dose 1 placebo followed 6-12 hours later by dose 2 placebo
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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 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).
- 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)
Other Outcome Measures
- 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.
- 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).
- 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.
- 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.
- 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).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 18 Years
Sexes Eligible for Study:
All
Accepts 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Connecticut Student Health Services | Storrs | Connecticut | United States | 06269-2011 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00402987
Other Study ID Numbers:
- A3191334
First Posted:
Nov 23, 2006
Last Update Posted:
Mar 3, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 1 center in the United States. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg/Placebo | Celecoxib 100mg/50mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg | Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo | Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg | Dose 1 placebo followed 6-12 hours later by dose 2 placebo |
| Period Title: Overall Study | ||||
| STARTED | 90 | 45 | 45 | 89 |
| COMPLETED | 90 | 45 | 44 | 89 |
| NOT COMPLETED | 0 | 0 | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg/Placebo | Celecoxib 100mg/50mg | Placebo | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg | Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo | Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg | Dose 1 placebo followed 6-12 hours later by dose 2 placebo | Total of all reporting groups |
| Overall Participants | 90 | 45 | 45 | 89 | 269 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
19.5
(1.3)
|
19.6
(1.4)
|
19.9
(2.3)
|
19.3
(1.4)
|
19.5
(1.5)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
55
61.1%
|
25
55.6%
|
15
33.3%
|
49
55.1%
|
144
53.5%
|
| Male |
35
38.9%
|
20
44.4%
|
30
66.7%
|
40
44.9%
|
125
46.5%
|
Outcome Measures
| Title | Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Celecoxib 100mg (Pooled) | Placebo |
|---|---|---|
| Arm/Group Description | Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled | Dose 1 placebo followed 6-12 hours later by dose 2 placebo |
| Measure Participants | 90 | 89 |
| Least Squares Mean (Standard Error) [units on a scale * hours] |
21.0
(2.20)
|
9.4
(2.21)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0003 |
| Comments | ||
| Method | generalized linear model | |
| Comments | p-value was calculated using Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 11.7 | |
| Confidence Interval |
() 95% 5.5 to 17.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo. MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg (Pooled) | Placebo |
|---|---|---|---|
| Arm/Group Description | Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg | Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled | Dose 1 placebo followed 6-12 hours later by dose 2 placebo |
| Measure Participants | 90 | 90 | 89 |
| 15 min |
1.62
(0.64)
|
1.92
(0.64)
|
0.40
(0.64)
|
| 30 min |
4.70
(0.90)
|
4.93
(0.90)
|
2.14
(0.91)
|
| 45 min |
9.57
(1.22)
|
7.05
(1.23)
|
3.85
(1.24)
|
| 60 min |
12.18
(1.47)
|
11.43
(1.47)
|
5.34
(1.48)
|
| 75 min |
17.24
(1.62)
|
13.24
(1.62)
|
6.60
(1.64)
|
| 90 min |
22.39
(1.88)
|
17.00
(1.88)
|
6.75
(1.90)
|
| 1.75 hours |
24.68
(1.99)
|
18.80
(1.99)
|
7.41
(2.01)
|
| 2 hours |
26.63
(2.19)
|
21.51
(2.19)
|
8.06
(2.21)
|
| 3 hours |
27.90
(2.29)
|
22.21
(2.29)
|
9.06
(2.31)
|
| 4 hours |
25.52
(2.31)
|
23.15
(2.31)
|
10.35
(2.33)
|
| 5 hours |
24.12
(2.26)
|
23.56
(2.26)
|
10.47
(2.28)
|
| 6 hours |
21.42
(2.24)
|
20.59
(2.24)
|
9.04
(2.26)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.212 |
| Comments | Analysis at 15 min Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.056 |
| Comments | Analysis at 30 min Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | Analysis at 45 min Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | Analysis at 60 min Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 75 min Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 90 min Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 1.75 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 2 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 3 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 4 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 5 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 6 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Title | Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg/Placebo | Celecoxib 100mg/50mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg | Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo | Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg | Dose 1 placebo followed 6-12 hours later by dose 2 placebo |
| Measure Participants | 85 | 43 | 44 | 82 |
| 7 hours |
20.82
(2.30)
|
22.01
(3.26)
|
18.34
(3.25)
|
9.32
(2.33)
|
| 8 hours |
20.39
(2.29)
|
20.81
(3.24)
|
19.93
(3.23)
|
8.12
(2.31)
|
| 9 hours |
21.39
(2.36)
|
19.18
(3.35)
|
18.87
(3.33)
|
9.92
(2.38)
|
| 10 hours |
21.26
(2.40)
|
18.02
(3.40)
|
18.06
(3.39)
|
9.56
(2.42)
|
| 11 hours |
19.65
(2.40)
|
17.43
(3.40)
|
18.99
(3.39)
|
9.29
(2.43)
|
| 12 hours |
19.01
(2.50)
|
15.01
(3.54)
|
20.22
(3.52)
|
8.60
(2.52)
|
| 24 hours |
18.43
(2.58)
|
16.50
(3.66)
|
19.44
(3.65)
|
12.81
(2.61)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | Analysis at 7 hours Overall P-value | |
| Method | Generalized Linear Model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 8 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.006 |
| Comments | Analysis at 9 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | Analysis at 10 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.014 |
| Comments | Analysis at 11 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.012 |
| Comments | Analysis at 12 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.365 |
| Comments | Analysis at 24 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Title | Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo. MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg (Pooled) | Placebo |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 90 | 90 | 89 |
| 15 min |
0.2
(0.1)
|
0.2
(0.1)
|
0.1
(0.1)
|
| 30 min |
1.0
(0.2)
|
1.1
(0.2)
|
0.4
(0.2)
|
| 45 min |
2.8
(0.4)
|
2.6
(0.4)
|
1.1
(0.5)
|
| 60 min |
5.5
(0.7)
|
4.9
(0.7)
|
2.3
(0.7)
|
| 75 min |
9.2
(1.0)
|
8.0
(1.0)
|
3.8
(1.0)
|
| 90 min |
14.1
(1.4)
|
11.8
(1.4)
|
5.4
(1.4)
|
| 1.75 hours |
20.0
(1.8)
|
16.2
(1.8)
|
7.2
(1.8)
|
| 2 hours |
26.4
(2.3)
|
21.3
(2.3)
|
9.1
(2.3)
|
| 3 hours |
53.7
(4.3)
|
43.1
(4.3)
|
17.7
(4.4)
|
| 4 hours |
80.4
(6.5)
|
65.8
(6.5)
|
27.4
(6.5)
|
| 5 hours |
105.2
(8.5)
|
89.2
(8.5)
|
37.8
(8.6)
|
| 6 hours |
128.0
(10.5)
|
111.2
(10.5)
|
47.6
(10.6)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.180 |
| Comments | Analysis at 15 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized Linear Model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.069 |
| Comments | Analysis at 30 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.010 |
| Comments | Analysis at 45 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | Analysis at 60 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 75 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 90 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 1.75 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 3 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 4 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 5 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 6 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.096 |
| Comments | Analysis at 15 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.034 |
| Comments | Analysis at 30 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.022 |
| Comments | Analysis at 45 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.010 |
| Comments | Analysis at 60 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | Analysis at 75 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | Analysis at 90 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | Analysis at 1.75 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 3 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 4 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 5 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 6 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.741 |
| Comments | Analysis at 15 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 26
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.759 |
| Comments | Analysis at 30 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 27
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.775 |
| Comments | Analysis at 45 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 28
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.561 |
| Comments | Analysis at 60 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 29
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.419 |
| Comments | Analysis at 75 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 30
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.237 |
| Comments | Analysis at 90 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 31
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.146 |
| Comments | Analysis at 1.75 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 32
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.113 |
| Comments | Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 33
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.086 |
| Comments | Analyaia at 3 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 34
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.111 |
| Comments | Analysis at 4 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 35
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.183 |
| Comments | Analysis at 5 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 36
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.259 |
| Comments | Analysis at 6 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Title | Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Celecoxib 50mg/50mg | Celecoxib 100 mg / Placebo | Celecoxib 100mg / 50mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | ||||
| Measure Participants | 85 | 43 | 44 | 82 |
| 7 hours |
149.2
(12.4)
|
151.8
(17.5)
|
111.6
(17.5)
|
56.6
(12.5)
|
| 8 hours |
169.8
(14.3)
|
173.2
(20.3)
|
130.8
(20.2)
|
65.4
(14.5)
|
| 9 hours |
190.7
(16.3)
|
193.2
(23.1)
|
150.2
(23.0)
|
74.4
(16.5)
|
| 10 hours |
212.0
(18.2)
|
211.8
(25.9)
|
168.6
(25.8)
|
84.1
(18.4)
|
| 11 hours |
232.4
(20.2)
|
229.5
(28.7)
|
187.2
(28.6)
|
93.5
(20.5)
|
| 12 hours |
251.8
(22.3)
|
245.7
(31.6)
|
206.8
(31.5)
|
102.5
(22.5)
|
| 24 hours |
476.4
(48.7)
|
434.8
(69.0)
|
444.7
(68.8)
|
231.0
(49.2)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.017 |
| Comments | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.011 |
| Comments | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.009 |
| Comments | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.008 |
| Comments | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.008 |
| Comments | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.008 |
| Comments | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.008 |
| Comments | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.012 |
| Comments | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.904 |
| Comments | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.891 |
| Comments | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.929 |
| Comments | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.994 |
| Comments | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.933 |
| Comments | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 26
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.876 |
| Comments | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 27
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.622 |
| Comments | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 28
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.081 |
| Comments | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 29
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.117 |
| Comments | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 30
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.152 |
| Comments | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 31
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.171 |
| Comments | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 32
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.197 |
| Comments | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 33
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.244 |
| Comments | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 34
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.708 |
| Comments | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 35
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.106 |
| Comments | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 36
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.140 |
| Comments | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 37
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.188 |
| Comments | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 38
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.239 |
| Comments | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 39
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.297 |
| Comments | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 40
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.383 |
| Comments | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 41
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.919 |
| Comments | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 42
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Title | Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo. MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100 mg (Pooled) | Placebo |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 90 | 90 | 89 |
| 15 min |
0.12
(0.04)
|
0.09
(0.04)
|
0.16
(0.04)
|
| 30 min |
0.41
(0.07)
|
0.34
(0.07)
|
0.34
(0.07)
|
| 45 min |
0.74
(0.09)
|
0.69
(0.09)
|
0.52
(0.09)
|
| 60 min |
1.22
(0.12)
|
1.01
(0.12)
|
0.64
(0.12)
|
| 75 min |
1.58
(0.13)
|
1.27
(0.13)
|
0.79
(0.14)
|
| 90 min |
1.88
(0.15)
|
1.61
(0.15)
|
0.88
(0.15)
|
| 1.75 hours |
2.10
(0.16)
|
1.74
(0.16)
|
0.93
(0.16)
|
| 2 hours |
2.22
(0.17)
|
1.93
(0.17)
|
0.92
(0.17)
|
| 3 hours |
2.13
(0.17)
|
1.92
(0.17)
|
0.92
(0.17)
|
| 4 hours |
2.08
(0.17)
|
1.96
(0.17)
|
1.10
(0.17)
|
| 5 hours |
2.00
(0.17)
|
1.97
(0.17)
|
1.07
(0.17)
|
| 6 hours |
1.81
(0.17)
|
1.86
(0.17)
|
0.96
(0.17)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.537 |
| Comments | Analysis at 15 min Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.697 |
| Comments | Analysis at 30 min Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.203 |
| Comments | Analysis at 45 min Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | Analysis at 60 min Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 75 min Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 90 min Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 1.75 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 2 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 3 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 4 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 5 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 6 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Title | Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Celecoxib 50mg/50mg | Celecoxib 100 mg / Placebo | Celecoxib 100mg / 50mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | ||||
| Measure Participants | 85 | 43 | 44 | 82 |
| 7 hours |
1.71
(0.17)
|
2.00
(0.24)
|
1.67
(0.24)
|
0.93
(0.17)
|
| 8 hours |
1.68
(0.17)
|
1.80
(0.24)
|
1.71
(0.24)
|
0.97
(0.17)
|
| 9 hours |
1.69
(0.17)
|
1.76
(0.25)
|
1.56
(0.25)
|
1.08
(0.17)
|
| 10 hours |
1.74
(0.17)
|
1.67
(0.25)
|
1.51
(0.25)
|
1.08
(0.18)
|
| 11 hours |
1.67
(0.18)
|
1.58
(0.25)
|
1.60
(0.25)
|
1.10
(0.18)
|
| 12 hours |
1.56
(0.18)
|
1.42
(0.25)
|
1.53
(0.25)
|
1.07
(0.18)
|
| 24 hours |
1.69
(0.19)
|
1.62
(0.27)
|
1.60
(0.27)
|
1.31
(0.19)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | Analysis at 7 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | Analysis at 8 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.046 |
| Comments | Analysis at 9 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.046 |
| Comments | Analysis at 10 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.111 |
| Comments | Analysis at 11 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.226 |
| Comments | Analysis at 12 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.537 |
| Comments | Analysis at 24 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Title | Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 6 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100 mg (Pooled) | Placebo |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 90 | 90 | 89 |
| Number [subjects] |
28
|
31
|
13
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.010 |
| Comments | Treatment as a factor | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.64 | |
| Confidence Interval |
() 95% 1.3 to 5.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | Treatment as a factor | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 3.07 | |
| Confidence Interval |
() 95% 1.5 to 6.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.634 |
| Comments | Treatment as a factor | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.16 | |
| Confidence Interval |
() 95% 0.6 to 2.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 12 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100 mg / Placebo | Celecoxib 100mg / 50mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | ||||
| Measure Participants | 90 | 45 | 45 | 89 |
| Number [subjects] |
21
|
13
|
12
|
14
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.202 |
| Comments | Treatment as a factor | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.63 | |
| Confidence Interval |
() 95% 0.8 to 3.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.077 |
| Comments | Treatment as a factor | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.18 | |
| Confidence Interval |
() 95% 0.9 to 5.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.134 |
| Comments | Treatment as a factor | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.95 | |
| Confidence Interval |
() 95% 0.8 to 4.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.671 |
| Comments | Treatment as a factor | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.84 | |
| Confidence Interval |
() 95% 0.4 to 1.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.484 |
| Comments | Treatment as a factor | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.75 | |
| Confidence Interval |
() 95% 0.3 to 1.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.814 |
| Comments | Treatment as a factor | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.12 | |
| Confidence Interval |
() 95% 0.4 to 2.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Time to Perceptible Pain Relief |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Celecoxib 50mg/50mg | Celecoxib 100 mg (Pooled) | Placebo |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 90 | 90 | 89 |
| Median (95% Confidence Interval) [minutes] |
49
|
61
|
97
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | 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 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | p-value for distribution of time to perceptible pain relief | |
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | 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 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | p-value for distribution of time to perceptible pain relief | |
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | 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 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | p-value for distribution of time to perceptible pain relief | |
| Method | Log Rank | |
| Comments | ||
| Title | Time to Meaningful Pain Relief |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Celecoxib 50mg/50mg | Celecoxib 100 mg (Pooled) | Placebo |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 90 | 90 | 89 |
| Number [subjects] |
36
|
33
|
15
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | p-value for distribution of time to meaningful pain relief | |
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | 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 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | p-value for distribution of time to meaningful pain relief | |
| Method | Log Rank | |
| Comments | ||
| Title | Time to Onset of Analgesia |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Celecoxib 50mg/50mg | Celecoxib 100 mg (Pooled) | Placebo |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 90 | 90 | 89 |
| Number [subjects] |
36
|
34
|
15
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | 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 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | p-value for distribution of time to onset of analgesia | |
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | 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 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | p-value for distribution of time to onset of analgesia | |
| Method | Log Rank | |
| Comments | ||
| Title | Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100 mg (Pooled) | Placebo |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 89 | 89 | 89 |
| Excellent (4) |
5
|
4
|
2
|
| Good (3) |
24
|
25
|
5
|
| Fair (2) |
25
|
27
|
22
|
| Poor (1) |
35
|
33
|
60
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Overall test of Celecoxib 50mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor). | |
| Method | Mantel Haenszel | |
| Comments | Test of row mean score differences based on modified ridits (standardizing the mid-rank) | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Overall test of Celecoxib 100mg (pooled) versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor). | |
| Method | Mantel Haenszel | |
| Comments | Test of row mean score differences based on modified ridits (standardizing the mid-rank) | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.889 |
| Comments | Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg (pooled) that takes into account the ordered data (categories: excellent, good, fair, poor). | |
| Method | Mantel Haenszel | |
| Comments | Test of row mean score differences based on modified ridits (standardizing the mid-rank) | |
| Title | Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects analyzed at 24 hours were different for 2 groups: Celecoxib 100mg/Placebo=45 and Placebo=87. MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100 mg / Placebo | Celecoxib 100mg / 50mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | ||||
| Measure Participants | 89 | 44 | 44 | 85 |
| Excellent (4) - 12 hours |
8
|
5
|
0
|
1
|
| Good (3) - 12 hours |
23
|
10
|
13
|
10
|
| Fair (2) - 12 hours |
21
|
11
|
11
|
18
|
| Poor (1) - 12 hours |
37
|
18
|
20
|
56
|
| Excellent (4) - 24 hours |
7
|
4
|
2
|
2
|
| Good (3) - 24 hours |
20
|
13
|
9
|
13
|
| Fair (2) - 24 hours |
25
|
7
|
15
|
15
|
| Poor (1) - 24 hours |
37
|
21
|
18
|
57
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 12 hours Overall test of Celecoxib 50mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor). | |
| Method | Mantel Haenszel | |
| Comments | Test of row mean score differences based on modified ridits (standardizing the mid-rank) | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | Analysis at 12 hours Overall test of Celecoxib 100mg/Placebo versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor). | |
| Method | Mantel Haenszel | |
| Comments | Test of row mean score differences based on modified ridits (standardizing the mid-rank) | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.015 |
| Comments | Analysis at 12 hours Overall test of Celecoxib 100mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor). | |
| Method | Mantel Haenszel | |
| Comments | Test of row mean score differences based on modified ridits (standardizing the mid-rank) | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.411 |
| Comments | Analysis at 12 hours Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor). | |
| Method | Mantel Haenszel | |
| Comments | Test of row mean score differences based on modified ridits (standardizing the mid-rank) | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.930 |
| Comments | Analysis at 12 hours Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/Placebo that takes into account the ordered data (categories: excellent, good, fair, poor). | |
| Method | Mantel Haenszel | |
| Comments | Test of row mean score differences based on modified ridits (standardizing the mid-rank) | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.438 |
| Comments | Analysis at 12 hours Overall test of Celecoxib 100mg/Placebo versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor). | |
| Method | Mantel Haenszel | |
| Comments | Test of row mean score differences based on modified ridits (standardizing the mid-rank) | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | Analysis at 24 hours Overall test of Celecoxib 50mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor). | |
| Method | Mantel Haenszel | |
| Comments | Test of row mean score differences based on modified ridits (standardizing the mid-rank) | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.013 |
| Comments | Analysis at 24 hours Overall test of Celecoxib 100mg/Placebo versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor). | |
| Method | Mantel Haenszel | |
| Comments | Test of row mean score differences based on modified ridits (standardizing the mid-rank) | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.015 |
| Comments | Analysis at 24 hours Overall test of Celecoxib 100mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor). | |
| Method | Mantel Haenszel | |
| Comments | Test of row mean score differences based on modified ridits (standardizing the mid-rank) | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.748 |
| Comments | Analysis at 24 hours Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor). | |
| Method | Mantel Haenszel | |
| Comments | Test of row mean score differences based on modified ridits (standardizing the mid-rank) | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.958 |
| Comments | Analysis at 24 hours Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/Placebo that takes into account the ordered data (categories: excellent, good, fair, poor). | |
| Method | Mantel Haenszel | |
| Comments | Test of row mean score differences based on modified ridits (standardizing the mid-rank) | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.747 |
| Comments | Analysis at 24 hours Overall test of Celecoxib 100mg/Placebo versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor). | |
| Method | Mantel Haenszel | |
| Comments | Test of row mean score differences based on modified ridits (standardizing the mid-rank) | |
| Title | Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo. MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg (Pooled) | Placebo |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 90 | 90 | 89 |
| 15 min |
0.06
(0.04)
|
0.06
(0.04)
|
0.06
(0.04)
|
| 30 min |
0.39
(0.08)
|
0.36
(0.08)
|
0.29
(0.08)
|
| 45 min |
0.74
(0.10)
|
0.66
(0.10)
|
0.43
(0.10)
|
| 60 min |
1.17
(0.13)
|
0.97
(0.13)
|
0.60
(0.13)
|
| 75 min |
1.62
(0.15)
|
1.29
(0.15)
|
0.75
(0.15)
|
| 90 min |
1.97
(0.17)
|
1.64
(0.17)
|
0.76
(0.17)
|
| 1.75 hours |
2.24
(0.18)
|
1.86
(0.18)
|
0.79
(0.19)
|
| 2 hours |
2.39
(0.19)
|
2.03
(0.19)
|
0.78
(0.19)
|
| 3 hours |
2.43
(0.20)
|
2.09
(0.20)
|
0.85
(0.21)
|
| 4 hours |
2.14
(0.21)
|
2.12
(0.21)
|
1.01
(0.21)
|
| 5 hours |
2.03
(0.20)
|
2.06
(0.21)
|
1.04
(0.21)
|
| 6 hours |
1.83
(0.20)
|
1.90
(0.20)
|
0.90
(0.21)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.999 |
| Comments | Analysis at 15 min Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.609 |
| Comments | Analysis at 30 min Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.076 |
| Comments | Analysis at 45 min Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.008 |
| Comments | Analysis at 60 min Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 75 min Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 90 min Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 1.75 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 2 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Continuous data were analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 3 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 4 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 5 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | Analysis at 6 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Title | Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg/Placebo | Celecoxib 100mg/50mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | ||||
| Measure Participants | 85 | 43 | 44 | 82 |
| 7 hours |
1.65
(0.21)
|
1.95
(0.30)
|
1.68
(0.29)
|
0.78
(0.21)
|
| 8 hours |
1.67
(0.21)
|
1.65
(0.30)
|
1.70
(0.30)
|
0.76
(0.22)
|
| 9 hours |
1.76
(0.22)
|
1.60
(0.32)
|
1.65
(0.32)
|
0.90
(0.23)
|
| 10 hours |
1.80
(0.23)
|
1.58
(0.33)
|
1.63
(0.32)
|
0.87
(0.23)
|
| 11 hours |
1.76
(0.23)
|
1.53
(0.32)
|
1.76
(0.32)
|
0.87
(0.23)
|
| 12 hours |
1.53
(0.23)
|
1.37
(0.33)
|
1.80
(0.33)
|
0.82
(0.24)
|
| 24 hours |
1.62
(0.25)
|
1.46
(0.36)
|
1.78
(0.35)
|
1.17
(0.25)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | Analysis at 7 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.009 |
| Comments | Analysis at 8 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.043 |
| Comments | Analysis at 9 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.032 |
| Comments | Analysis at 10 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.029 |
| Comments | Analysis at 11 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.066 |
| Comments | Analysis at 12 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.482 |
| Comments | Analysis at 24 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Title | Sore Throat Pain Intensity Difference (SPID2) as Measured by Throat Soreness Scale (TSS) at 2 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg (Pooled) | Placebo |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 90 | 90 | 89 |
| Least Squares Mean (Standard Error) [units on a scale * hours] |
2.4
(0.21)
|
2.0
(0.21)
|
1.0
(0.21)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.3 | |
| Confidence Interval |
() 95% 0.8 to 1.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.9 | |
| Confidence Interval |
() 95% 0.4 to 1.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.186 |
| Comments | Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.4 | |
| Confidence Interval |
() 95% -1.0 to 0.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg (Pooled) | Placebo |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 90 | 90 | 89 |
| 15 min |
0.01
(0.01)
|
0.01
(0.01)
|
0.01
(0.01)
|
| 30 min |
0.07
(0.02)
|
0.06
(0.02)
|
0.05
(0.02)
|
| 45 min |
0.21
(0.03)
|
0.19
(0.03)
|
0.14
(0.04)
|
| 60 min |
0.45
(0.06)
|
0.39
(0.06)
|
0.27
(0.06)
|
| 75 min |
0.80
(0.09)
|
0.67
(0.09)
|
0.44
(0.09)
|
| 90 min |
1.24
(0.13)
|
1.04
(0.13)
|
0.63
(0.13)
|
| 1.75 hours |
1.77
(0.16)
|
1.48
(0.16)
|
0.82
(0.17)
|
| 2 hours |
2.35
(0.21)
|
1.96
(0.21)
|
1.02
(0.21)
|
| 3 hours |
4.76
(0.39)
|
4.02
(0.39)
|
1.83
(0.39)
|
| 4 hours |
7.05
(0.58)
|
6.12
(0.58)
|
2.76
(0.59)
|
| 5 hours |
9.13
(0.76)
|
8.21
(0.77)
|
3.79
(0.77)
|
| 6 hours |
11.07
(0.94)
|
10.20
(0.94)
|
4.75
(0.95)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.961 |
| Comments | Analysis at 15 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.985 |
| Comments | Analysis at 15 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.975 |
| Comments | Analysis at 15 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.532 |
| Comments | Analysis at 30 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.690 |
| Comments | Analysis at 30 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.820 |
| Comments | Analysis at 30 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.180 |
| Comments | Analysis at 45 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.344 |
| Comments | Analysis at 45 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.693 |
| Comments | Analysis at 45 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.039 |
| Comments | Analysis at 60 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.154 |
| Comments | Analysis at 60 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.521 |
| Comments | Analysis at 60 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.006 |
| Comments | Analysis at 75 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.070 |
| Comments | Analysis at 75 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.344 |
| Comments | Analysis at 75 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | Analysis at 90 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.022 |
| Comments | Analysis at 90 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.249 |
| Comments | Analysis at 90 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 1.75 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.006 |
| Comments | Analysis at 1.75 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.205 |
| Comments | Analysis at 1.75 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.186 |
| Comments | Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 3 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 26
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 3 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 27
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.179 |
| Comments | Analysis at 3 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 28
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 4 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 29
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 4 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 30
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.259 |
| Comments | Analysis at 4 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 31
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 5 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 32
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 5 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 33
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.393 |
| Comments | Analysis at 5 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 34
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 6 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 35
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 6 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 36
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.512 |
| Comments | Analysis at 6 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Title | Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg/Placebo | Celecoxib 100mg/50mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | ||||
| Measure Participants | 85 | 43 | 44 | 82 |
| 7 hours |
12.8
(1.1)
|
14.2
(1.6)
|
9.9
(1.6)
|
5.6
(1.1)
|
| 8 hours |
14.5
(1.3)
|
16.0
(1.8)
|
11.6
(1.8)
|
6.3
(1.3)
|
| 9 hours |
16.2
(1.5)
|
17.7
(2.1)
|
13.3
(2.1)
|
7.2
(1.5)
|
| 10 hours |
18.0
(1.7)
|
19.3
(2.4)
|
14.9
(2.3)
|
8.1
(1.7)
|
| 11 hours |
19.7
(1.8)
|
20.8
(2.6)
|
16.6
(2.6)
|
8.9
(1.9)
|
| 12 hours |
21.4
(2.0)
|
22.3
(2.9)
|
18.4
(2.9)
|
9.8
(2.1)
|
| 24 hours |
40.3
(4.5)
|
39.2
(6.4)
|
39.8
(6.4)
|
21.7
(4.6)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.026 |
| Comments | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.463 |
| Comments | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.131 |
| Comments | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.053 |
| Comments | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.020 |
| Comments | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.484 |
| Comments | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.197 |
| Comments | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.086 |
| Comments | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.018 |
| Comments | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.561 |
| Comments | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.252 |
| Comments | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.136 |
| Comments | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.018 |
| Comments | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.653 |
| Comments | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.287 |
| Comments | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.191 |
| Comments | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 26
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 27
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.018 |
| Comments | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 28
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.741 |
| Comments | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 29
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.326 |
| Comments | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 30
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.256 |
| Comments | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 31
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 32
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 33
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.016 |
| Comments | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 34
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.808 |
| Comments | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 35
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.394 |
| Comments | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 36
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.343 |
| Comments | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 37
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 38
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.029 |
| Comments | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 39
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.023 |
| Comments | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 40
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.892 |
| Comments | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 41
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.952 |
| Comments | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 42
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.948 |
| Comments | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Title | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo. MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg (Pooled) | Placebo |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 90 | 90 | 89 |
| 15 min |
1.69
(0.89)
|
1.16
(0.89)
|
0.81
(0.89)
|
| 30 min |
4.85
(1.21)
|
3.14
(1.21)
|
1.11
(1.21)
|
| 45 min |
6.99
(1.43)
|
5.75
(1.43)
|
2.85
(1.44)
|
| 60 min |
11.21
(1.65)
|
8.02
(1.65)
|
3.53
(1.66)
|
| 75 min |
14.31
(1.84)
|
10.47
(1.84)
|
3.95
(1.85)
|
| 90 min |
17.40
(1.99)
|
12.21
(1.99)
|
3.97
(2.00)
|
| 1.75 hours |
20.52
(2.11)
|
15.15
(2.11)
|
4.45
(2.12)
|
| 2 hours |
21.76
(2.25)
|
16.50
(2.25)
|
4.99
(2.26)
|
| 3 hours |
22.20
(2.17)
|
18.39
(2.17)
|
4.20
(2.18)
|
| 4 hours |
20.53
(2.33)
|
18.27
(2.33)
|
7.28
(2.34)
|
| 5 hours |
18.40
(2.31)
|
18.11
(2.31)
|
6.02
(2.32)
|
| 6 hours |
16.62
(2.27)
|
16.43
(2.27)
|
5.70
(2.29)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.775 |
| Comments | Analysis at 15 min Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.094 |
| Comments | Analysis at 30 min Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.114 |
| Comments | Analysis at 45 min Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | Analysis at 60 min Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 75 min Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 90 min Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 1.75 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 2 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 3 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 4 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 5 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | Analysis at 6 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Title | Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg/Placebo | Celecoxib 100mg/50mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | ||||
| Measure Participants | 85 | 43 | 44 | 82 |
| 7 hours |
16.91
(2.35)
|
18.11
(3.32)
|
11.38
(3.32)
|
4.86
(2.36)
|
| 8 hours |
16.53
(2.38)
|
17.29
(3.37)
|
13.40
(3.37)
|
4.88
(2.39)
|
| 9 hours |
16.59
(2.35)
|
15.10
(3.32)
|
12.68
(3.32)
|
5.46
(2.36)
|
| 10 hours |
16.61
(2.39)
|
14.32
(3.38)
|
11.68
(3.38)
|
5.85
(2.41)
|
| 11 hours |
15.01
(2.45)
|
12.99
(3.46)
|
13.13
(3.46)
|
5.22
(2.46)
|
| 12 hours |
15.40
(2.51)
|
11.44
(3.55)
|
13.41
(3.55)
|
5.30
(2.53)
|
| 24 hours |
14.25
(2.70)
|
13.67
(3.83)
|
13.24
(3.82)
|
8.79
(2.72)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | Analysis at 7 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | Analysis at 8 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | Analysis at 9 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.015 |
| Comments | Analysis at 10 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.033 |
| Comments | Analysis at 11 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.036 |
| Comments | Analysis at 12 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo, Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.500 |
| Comments | Analysis at 24 hours Overall P-value | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Title | Sum of Sore Throat Pain Intensity Difference (SPID2) as Measured by Difficulty Swallowing Scale (DSS) at 2 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg (Pooled) | Placebo |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 90 | 90 | 89 |
| Least Squares Mean (Standard Error) [units on a scale * hours] |
22.0
(2.73)
|
16.0
(2.73)
|
5.8
(2.75)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 16.2 | |
| Confidence Interval |
() 95% 8.5 to 23.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.009 |
| Comments | Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 10.2 | |
| Confidence Interval |
() 95% 2.6 to 17.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.127 |
| Comments | Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -5.9 | |
| Confidence Interval |
() 95% -13.5 to 1.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo. MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg (Pooled) | Placebo |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 90 | 90 | 89 |
| 15 min |
0.2
(0.1)
|
0.1
(0.1)
|
0.1
(0.1)
|
| 30 min |
1.0
(0.3)
|
0.7
(0.3)
|
0.3
(0.3)
|
| 45 min |
2.5
(0.6)
|
1.8
(0.6)
|
0.8
(0.6)
|
| 60 min |
4.8
(1.0)
|
3.5
(1.0)
|
1.6
(1.0)
|
| 75 min |
8.0
(1.4)
|
5.8
(1.4)
|
2.6
(1.4)
|
| 90 min |
11.9
(1.8)
|
8.7
(1.8)
|
3.6
(1.8)
|
| 1.75 hours |
16.7
(2.2)
|
12.1
(2.2)
|
4.6
(2.3)
|
| 2 hours |
22.0
(2.7)
|
16.0
(2.7)
|
5.8
(2.8)
|
| 3 hours |
43.9
(4.8)
|
33.5
(4.8)
|
10.4
(4.8)
|
| 4 hours |
65.3
(6.8)
|
51.8
(6.8)
|
16.1
(6.9)
|
| 5 hours |
84.8
(9.0)
|
70.0
(9.0)
|
22.8
(9.0)
|
| 6 hours |
102.3
(11.0)
|
87.3
(11.0)
|
28.6
(11.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.480 |
| Comments | Analysis at 15 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.780 |
| Comments | Analysis at 15 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.667 |
| Comments | Analysis at 15 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.153 |
| Comments | Analysis at 30 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.479 |
| Comments | Analysis at 30 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.469 |
| Comments | Analysis at 30 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.062 |
| Comments | Analysis at 45 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.284 |
| Comments | Analysis at 45 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.421 |
| Comments | Analysis at 45 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.022 |
| Comments | Analysis at 60 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.171 |
| Comments | Analysis at 60 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.354 |
| Comments | Analysis at 60 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | Analysis at 75 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.090 |
| Comments | Analysis at 75 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.262 |
| Comments | Analysis at 75 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | Analysis at 90 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.044 |
| Comments | Analysis at 90 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.194 |
| Comments | Analysis at 90 min Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 1.75 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.020 |
| Comments | Analysis at 1.75 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.148 |
| Comments | Analysis at 1.75 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.009 |
| Comments | Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.127 |
| Comments | Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 3 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 26
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | Analysis at 3 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 27
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.122 |
| Comments | Analysis at 3 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 28
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 4 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 29
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 4 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 30
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.164 |
| Comments | Analysis at 4 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 31
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 5 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 32
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 5 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 33
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.244 |
| Comments | Analysis at 5 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 34
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 6 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 35
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 6 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 36
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.336 |
| Comments | Analysis at 6 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Title | Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg/Placebo | Celecoxib 100mg/50mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | ||||
| Measure Participants | 85 | 43 | 44 | 82 |
| 7 hours |
119.1
(13.0)
|
133.6
(18.3)
|
72.2
(18.3)
|
33.9
(13.0)
|
| 8 hours |
135.8
(15.0)
|
151.3
(21.3)
|
84.5
(21.3)
|
38.8
(15.1)
|
| 9 hours |
152.3
(17.1)
|
167.5
(24.2)
|
97.6
(24.2)
|
43.9
(17.2)
|
| 10 hours |
168.9
(19.1)
|
182.2
(27.0)
|
109.8
(27.0)
|
49.6
(19.2)
|
| 11 hours |
184.7
(21.1)
|
195.8
(29.9)
|
122.2
(29.9)
|
55.1
(21.3)
|
| 12 hours |
200.0
(23.2)
|
208.0
(32.8)
|
135.4
(32.8)
|
60.4
(23.4)
|
| 24 hours |
377.9
(50.4)
|
358.7
(71.3)
|
295.3
(71.3)
|
144.9
(50.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.090 |
| Comments | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.518 |
| Comments | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.038 |
| Comments | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.019 |
| Comments | Analysis at 7 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.081 |
| Comments | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.552 |
| Comments | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.050 |
| Comments | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.027 |
| Comments | Analysis at 8 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.071 |
| Comments | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.609 |
| Comments | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.065 |
| Comments | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.042 |
| Comments | Analysis at 9 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.070 |
| Comments | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.689 |
| Comments | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.075 |
| Comments | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Continuous data were analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.059 |
| Comments | Analysis at 10 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 26
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 27
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.069 |
| Comments | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 28
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.762 |
| Comments | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 29
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.089 |
| Comments | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 30
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.083 |
| Comments | Analysis at 11 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 31
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 32
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 33
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.064 |
| Comments | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 34
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.841 |
| Comments | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 35
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.110 |
| Comments | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 36
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.119 |
| Comments | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 37
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 38
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.015 |
| Comments | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 39
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.087 |
| Comments | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 40
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.826 |
| Comments | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 41
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.345 |
| Comments | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
Statistical Analysis 42
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.530 |
| Comments | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Title | Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 6 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg (Pooled) | Placebo |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 90 | 90 | 89 |
| Number [subjects] |
22
|
24
|
14
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.149 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.73 | |
| Confidence Interval |
() 95% 0.8 to 3.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.076 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.95 | |
| Confidence Interval |
() 95% 0.9 to 4.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.733 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.12 | |
| Confidence Interval |
() 95% 0.6 to 2.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 12 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg/Placebo | Celecoxib 100mg/50mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | ||||
| Measure Participants | 90 | 45 | 45 | 89 |
| Number [subjects] |
24
|
12
|
10
|
12
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.030 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.33 | |
| Confidence Interval |
() 95% 1.1 to 5.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.064 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.33 | |
| Confidence Interval |
() 95% 1.0 to 5.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.201 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.83 | |
| Confidence Interval |
() 95% 0.7 to 4.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.575 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.27 | |
| Confidence Interval |
() 95% 0.5 to 3.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.000 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.00 | |
| Confidence Interval |
() 95% 0.4 to 2.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.624 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.27 | |
| Confidence Interval |
() 95% 0.5 to 3.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Total Pain Relief (TOTPAR) at 2 and 6 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects evaluated at 6 hours: 85 for 50mg/50mg; 87 for 100mg (pooled); 85 for Placebo. MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg (Pooled) | Placebo |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 90 | 90 | 89 |
| 2 hours |
2.6
(0.2)
|
2.2
(0.2)
|
1.3
(0.2)
|
| 6 hours |
10.6
(0.8)
|
9.9
(0.8)
|
5.3
(0.8)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.28 | |
| Confidence Interval |
() 95% 0.7 to 1.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.88 | |
| Confidence Interval |
() 95% 0.3 to 1.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.177 |
| Comments | Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.40 | |
| Confidence Interval |
() 95% -1.0 to 0.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 6 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 5.25 | |
| Confidence Interval |
() 95% 3.0 to 7.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 6 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 4.54 | |
| Confidence Interval |
() 95% 2.3 to 6.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.531 |
| Comments | Analysis at 6 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.72 | |
| Confidence Interval |
() 95% -3.0 to 1.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Total Pain Relief (TOTPAR) at 12 and 24 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects evaluated at 24 hours: 84 for 50mg/50mg; 43 for 100mg/Placebo; 44 for 100mg/50mg; 81 for Placebo. MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg /Placebo | Celecoxib 100mg/50mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | ||||
| Measure Participants | 81 | 40 | 43 | 75 |
| 12 hours |
20.6
(1.7)
|
22.0
(2.4)
|
17.5
(2.4)
|
11.6
(1.7)
|
| 24 hours |
40.9
(3.6)
|
41.5
(5.1)
|
36.7
(5.1)
|
27.3
(3.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 9.07 | |
| Confidence Interval |
() 95% 4.4 to 13.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 10.46 | |
| Confidence Interval |
() 95% 4.7 to 16.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.041 |
| Comments | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 5.96 | |
| Confidence Interval |
() 95% 0.2 to 11.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.633 |
| Comments | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.39 | |
| Confidence Interval |
() 95% -7.1 to 4.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.284 |
| Comments | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.11 | |
| Confidence Interval |
() 95% -2.6 to 8.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.180 |
| Comments | Analysis at 12 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 4.50 | |
| Confidence Interval |
() 95% -2.1 to 11.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.009 |
| Comments | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 13.57 | |
| Confidence Interval |
() 95% 3.4 to 23.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.026 |
| Comments | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 14.15 | |
| Confidence Interval |
() 95% 1.7 to 26.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.138 |
| Comments | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 9.39 | |
| Confidence Interval |
() 95% -3.0 to 21.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.926 |
| Comments | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.59 | |
| Confidence Interval |
() 95% -13.0 to 11.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.507 |
| Comments | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 4.18 | |
| Confidence Interval |
() 95% -8.2 to 16.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.513 |
| Comments | Analysis at 24 hours Pairwise comparison. No adjustment made for multiplicity. | |
| Method | Generalized linear model | |
| Comments | Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 4.77 | |
| Confidence Interval |
() 95% -9.6 to 19.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Subjects With >= 50% Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg (Pooled) | Placebo |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 90 | 90 | 89 |
| Number [subjects] |
18
|
19
|
7
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.023 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.93 | |
| Confidence Interval |
() 95% 1.2 to 7.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.015 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 3.13 | |
| Confidence Interval |
() 95% 1.2 to 7.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.854 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.07 | |
| Confidence Interval |
() 95% 0.5 to 2.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Subjects With >= 50% Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg/Placebo | Celecoxib 100mg/50mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | ||||
| Measure Participants | 90 | 45 | 45 | 89 |
| Number [subjects] |
18
|
12
|
8
|
6
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.013 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 3.46 | |
| Confidence Interval |
() 95% 1.3 to 9.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 5.03 | |
| Confidence Interval |
() 95% 1.7 to 14.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.057 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.99 | |
| Confidence Interval |
() 95% 1.0 to 9.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.758 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.16 | |
| Confidence Interval |
() 95% 0.5 to 2.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.381 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.69 | |
| Confidence Interval |
() 95% 0.3 to 1.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.313 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.68 | |
| Confidence Interval |
() 95% 0.6 to 4.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg (Pooled) | Placebo |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 90 | 90 | 89 |
| Number [subjects] |
18
|
19
|
7
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | NNT is the inverse of the absolute risk reduction at 6 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | NNT at 6 hours |
| Estimated Value | 8.2 | |
| Confidence Interval |
() 95% 4.5 to 46.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | NNT is the inverse of the absolute risk reduction at 6 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | NNT at 6 hours |
| Estimated Value | 7.5 | |
| Confidence Interval |
() 95% 4.3 to 32.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population Comparison Celecoxib 100mg/50mg - Placebo: the NNT value was non-estimable |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg/Placebo | Celecoxib 100mg/50mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | ||||
| Measure Participants | 90 | 45 | 45 | 89 |
| Number [subjects] |
18
|
12
|
8
|
6
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | NNT is the inverse of the absolute risk reduction at 12 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | NNT at 12 hours |
| Estimated Value | 7.5 | |
| Confidence Interval |
() 95% 4.3 to 28.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | NNT is the inverse of the absolute risk reduction at 12 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | NNT at 12 hours |
| Estimated Value | 5.0 | |
| Confidence Interval |
() 95% 3.0 to 16.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 2 and 6 Hours Post-First Dose |
|---|---|
| Description | >= 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg (Pooled) | Placebo |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 90 | 90 | 89 |
| 2 hours >=35% gone |
39
|
32
|
15
|
| 6 hours >=35% gone |
31
|
29
|
12
|
| 2 hours >=50% gone |
28
|
24
|
8
|
| 6 hours >=50% gone |
23
|
22
|
9
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis for 2 hours >=35% gone | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 3.77 | |
| Confidence Interval |
() 95% 1.9 to 7.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | Analysis for 2 hours >=35% gone | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.72 | |
| Confidence Interval |
() 95% 1.3 to 5.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.286 |
| Comments | Analysis for 2 hours >=35% gone | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.72 | |
| Confidence Interval |
() 95% 0.4 to 1.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | Analysis for 6 hours >=35% gone | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 3.37 | |
| Confidence Interval |
() 95% 1.6 to 7.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.004 |
| Comments | Analysis for 6 hours >=35% gone | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 3.05 | |
| Confidence Interval |
() 95% 1.4 to 6.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.752 |
| Comments | Analysis for 6 hours >=35% gone | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.90 | |
| Confidence Interval |
() 95% 0.5 to 1.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis for 2 hours >=50% gone | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 4.57 | |
| Confidence Interval |
() 95% 1.9 to 10.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | Analysis for 2 hours >=50% gone | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 3.68 | |
| Confidence Interval |
() 95% 1.6 to 8.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.511 |
| Comments | Analysis for 2 hours >=50% gone | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.81 | |
| Confidence Interval |
() 95% 0.4 to 1.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.009 |
| Comments | Analysis for 6 hours >=50% gone | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 3.05 | |
| Confidence Interval |
() 95% 1.3 to 7.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.014 |
| Comments | Analysis for 6 hours >=50% gone | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.88 | |
| Confidence Interval |
() 95% 1.2 to 6.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.863 |
| Comments | Analysis for 6 hours >=50% gone | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.94 | |
| Confidence Interval |
() 95% 0.5 to 1.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 12 Hours Post-First Dose |
|---|---|
| Description | >= 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg/Placebo | Celecoxib 100mg/50mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | ||||
| Measure Participants | 90 | 45 | 45 | 89 |
| 12 hours >=35% gone |
30
|
13
|
12
|
13
|
| 12 hours >=50% gone |
22
|
12
|
10
|
9
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.004 |
| Comments | 12 hours >=35% gone | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.92 | |
| Confidence Interval |
() 95% 1.4 to 6.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.052 |
| Comments | 12 hours >=35% gone | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.37 | |
| Confidence Interval |
() 95% 1.0 to 5.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.095 |
| Comments | 12 hours >=35% gone | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.13 | |
| Confidence Interval |
() 95% 0.9 to 5.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.431 |
| Comments | 12 hours >=35% gone | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.38 | |
| Confidence Interval |
() 95% 0.6 to 3.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.602 |
| Comments | 12 hours >=35% gone | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.23 | |
| Confidence Interval |
() 95% 0.6 to 2.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.814 |
| Comments | 12 hours >=35% gone | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.12 | |
| Confidence Interval |
() 95% 0.4 to 2.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.014 |
| Comments | 12 hours >=50% gone | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.88 | |
| Confidence Interval |
() 95% 1.2 to 6.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.016 |
| Comments | 12 hours >=50% gone | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 3.23 | |
| Confidence Interval |
() 95% 1.2 to 8.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.063 |
| Comments | 12 hours >=50% gone | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.54 | |
| Confidence Interval |
() 95% 0.9 to 6.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.775 |
| Comments | 12 hours >=50% gone | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.13 | |
| Confidence Interval |
() 95% 0.5 to 2.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.779 |
| Comments | 12 hours >=50% gone | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.89 | |
| Confidence Interval |
() 95% 0.4 to 2.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.624 |
| Comments | 12 hours >=50% gone | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.27 | |
| Confidence Interval |
() 95% 0.5 to 3.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 2 and 6 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg (Pooled) | Placebo |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 90 | 89 | 89 |
| meaningful relief - 2 hours- achieved |
31
|
26
|
12
|
| meaningful relief- 2 hours- not achieved |
59
|
63
|
77
|
| meaningful relief - 6 hours- achieved |
40
|
38
|
17
|
| meaningful relief- 6 hours- not achieved |
50
|
51
|
72
|
| much improvement - 2 hours- achieved |
22
|
22
|
10
|
| much improvement - 2 hours- not achieved |
68
|
67
|
79
|
| much improvement - 6 hours- achieved |
33
|
31
|
12
|
| much improvement - 6 hours- not achieved |
57
|
58
|
77
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | Analysis for meaningful Relief at 2 hours | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.012 |
| Comments | Analysis for meaningful Relief at 2 hours | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.453 |
| Comments | Analysis for meaningful Relief at 2 hours | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis for meaningful Relief at 6 hours | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | Analysis for meaningful Relief at 6 hours | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.814 |
| Comments | Analysis for meaningful Relief at 6 hours | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.024 |
| Comments | Analysis for Much Improvement at 2 hours | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.022 |
| Comments | Analysis for Much Improvement at 2 hours | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.966 |
| Comments | Analysis for Much Improvement at 2 hours | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | Analysis for Much Improvement at 6 hours | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | Analysis for Much Improvement at 6 hours | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.798 |
| Comments | Analysis for Much Improvement at 6 hours | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Title | Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg /Placebo | Celecoxib 100mg/50mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | ||||
| Measure Participants | 90 | 45 | 44 | 89 |
| Meaningful Relief - achieved |
44
|
26
|
20
|
20
|
| Meaningful Relief - not achieved |
46
|
19
|
24
|
69
|
| Much Improvement - achieved |
38
|
22
|
12
|
16
|
| Much Improvement - not achieved |
52
|
23
|
32
|
73
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis for Meaningful Relief | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis for Meaningful Relief | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.008 |
| Comments | Analysis for Meaningful Relief | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.709 |
| Comments | Analysis for Meaningful Relief | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.331 |
| Comments | Analysis for Meaningful Relief | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.246 |
| Comments | Analysis for Meaningful Relief | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | Analysis for Much Improvement | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis for Much Improvement | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.219 |
| Comments | Analysis for Much Improvement | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.095 |
| Comments | Analysis for Much Improvement | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.463 |
| Comments | Analysis for Much Improvement | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.038 |
| Comments | Analysis for Much Improvement | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Title | Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Had Perceptible Relief Onset Time Within 1 Hour |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg (Pooled) | Placebo |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 90 | 89 | 89 |
| Achieved |
31
|
27
|
12
|
| Not achieved |
59
|
62
|
77
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.008 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.557 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg/Placebo | Celecoxib 100mg/50mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | ||||
| Measure Participants | 90 | 45 | 44 | 89 |
| at 12 hours - Achieved |
32
|
16
|
12
|
11
|
| at 12 hours - Not Achieved |
58
|
29
|
32
|
78
|
| at 24 hours - Achieved |
28
|
16
|
9
|
11
|
| at 24 hours - Not Achieved |
62
|
29
|
35
|
78
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis at 12 hours | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | Analysis at 12 hours | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.036 |
| Comments | Analysis at 12 hours | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.339 |
| Comments | Analysis at 12 hours | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.000 |
| Comments | Analysis at 12 hours | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.401 |
| Comments | Analysis at 12 hours | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | Analysis at 24 hours | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | Analysis at 24 hours | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.223 |
| Comments | Analysis at 24 hours | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.198 |
| Comments | Analysis at 24 hours | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.604 |
| Comments | Analysis at 24 hours | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.117 |
| Comments | Analysis at 24 hours | |
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Title | Median Onset Time of First Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects who achieved meaningful relief within 6 hours |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg (Pooled) | Placebo |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 40 | 38 | 17 |
| Median (Full Range) [hours] |
0.75
|
0.63
|
0.50
|
| Title | Median Offset Time of No Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects who achieved Meaningful Relief within 6 hours |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg/Placebo | Celecoxib 100mg/50mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | ||||
| Measure Participants | 40 | 23 | 15 | 17 |
| Median (Full Range) [hours] |
8.00
|
8.00
|
8.00
|
10.00
|
| Title | Treatment Failures on STRRS Questionnaire |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg/Placebo | Celecoxib 100mg/50mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | ||||
| Measure Participants | 90 | 45 | 44 | 89 |
| Not treatment failures |
46
|
27
|
20
|
23
|
| Treatment failures |
44
|
18
|
24
|
66
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.025 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.539 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.329 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.171 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Title | Subjects Taking Rescue Medication |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg /Placebo | Celecoxib 100mg/50mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | ||||
| Measure Participants | 90 | 45 | 45 | 89 |
| Number [subjects] |
22
|
15
|
13
|
39
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.244 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.096 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.579 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.277 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.649 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Treatment as a factor | |
| Title | Treatment Satisfaction Questionnaire for Medication (TSQM vII) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg /Placebo | Celecoxib 100mg/50mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | ||||
| Measure Participants | 90 | 45 | 45 | 89 |
| Effectiveness |
41.5
(26.6)
|
40.6
(28.7)
|
34.3
(26.2)
|
26.1
(25.4)
|
| Side Effects |
96.3
(12.0)
|
96.7
(11.6)
|
97.9
(9.7)
|
98.6
(8.2)
|
| Convenience |
77.2
(15.1)
|
73.0
(17.4)
|
69.3
(16.8)
|
71.3
(14.6)
|
| Global Satisfaction |
49.1
(28.0)
|
47.8
(33.4)
|
42.2
(30.6)
|
36.0
(27.3)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Analysis of Effectiveness | |
| Method | Generalized linear model | |
| Comments | Treatment as a fixed effect | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 15.4 | |
| Confidence Interval |
() 95% 7.5 to 23.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | Analysis of Effectiveness | |
| Method | Generalized linear model | |
| Comments | Treatment as a fixed effect | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 14.4 | |
| Confidence Interval |
() 95% 4.9 to 24.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.096 |
| Comments | Analysis of Effectiveness | |
| Method | Generalized linear model | |
| Comments | Treatment as a fixed effect | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 8.2 | |
| Confidence Interval |
() 95% -1.5 to 17.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.141 |
| Comments | Analysis of Effectiveness | |
| Method | Generalized linear model | |
| Comments | Treatment as a fixed effect | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 7.2 | |
| Confidence Interval |
() 95% -2.4 to 16.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.849 |
| Comments | Analysis of Effectiveness | |
| Method | Generalized linear model | |
| Comments | Treatment as a fixed effect | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.9 | |
| Confidence Interval |
() 95% -8.6 to 10.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.266 |
| Comments | Analysis of Effectiveness | |
| Method | Generalized linear model | |
| Comments | Treatment as a fixed effect | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 6.3 | |
| Confidence Interval |
() 95% -4.8 to 17.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.141 |
| Comments | Analysis of Side Effects | |
| Method | Generalized linear model | |
| Comments | Treatment as a fixed effect | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -2.3 | |
| Confidence Interval |
() 95% -5.4 to 0.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.312 |
| Comments | Analysis of Side Effects | |
| Method | Generalized linear model | |
| Comments | Treatment as a fixed effect | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.9 | |
| Confidence Interval |
() 95% -5.7 to 1.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.724 |
| Comments | Analysis of Side Effects | |
| Method | Generalized linear model | |
| Comments | Treatment as a fixed effect | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.7 | |
| Confidence Interval |
() 95% -4.5 to 3.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.398 |
| Comments | Analysis of Side Effects | |
| Method | Generalized linear model | |
| Comments | Treatment as a fixed effect | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.6 | |
| Confidence Interval |
() 95% -5.4 to 2.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.846 |
| Comments | Analysis of Side Effects | |
| Method | Generalized linear model | |
| Comments | Treatment as a fixed effect | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.4 | |
| Confidence Interval |
() 95% -4.1 to 3.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.572 |
| Comments | Analysis of Side Effects | |
| Method | Generalized linear model | |
| Comments | Treatment as a fixed effect | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.3 | |
| Confidence Interval |
() 95% -5.6 to 3.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.014 |
| Comments | Analysis of Convenience | |
| Method | Generalized linear model | |
| Comments | Treatment as a fixed effect | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 5.8 | |
| Confidence Interval |
() 95% 1.2 to 10.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.573 |
| Comments | Analysis of Convenience | |
| Method | Generalized linear model | |
| Comments | Treatment as a fixed effect | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.6 | |
| Confidence Interval |
() 95% -4.0 to 7.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.482 |
| Comments | Analysis of Convenience | |
| Method | Generalized linear model | |
| Comments | Treatment as a fixed effect | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -2.0 | |
| Confidence Interval |
() 95% -7.7 to 3.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | Analysis of Convenience | |
| Method | Generalized linear model | |
| Comments | Treatment as a fixed effect | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 7.8 | |
| Confidence Interval |
() 95% 2.2 to 13.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.143 |
| Comments | Analysis of Convenience | |
| Method | Generalized linear model | |
| Comments | Treatment as a fixed effect | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 4.2 | |
| Confidence Interval |
() 95% -1.4 to 9.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.273 |
| Comments | Analysis of Convenience | |
| Method | Generalized linear model | |
| Comments | Treatment as a fixed effect | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.6 | |
| Confidence Interval |
() 95% -2.9 to 10.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | Analysis of Global Satisfaction | |
| Method | Generalized linear model | |
| Comments | Treatment as a fixed effect | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 13.0 | |
| Confidence Interval |
() 95% 4.4 to 21.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.029 |
| Comments | Analysis of Global Satisfaction | |
| Method | Generalized linear model | |
| Comments | Treatment as a fixed effect | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 11.7 | |
| Confidence Interval |
() 95% 1.2 to 22.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.251 |
| Comments | Analysis of Global Satisfaction | |
| Method | Generalized linear model | |
| Comments | Treatment as a fixed effect | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 6.2 | |
| Confidence Interval |
() 95% -4.4 to 16.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.204 |
| Comments | Analysis of Global Satisfaction | |
| Method | Generalized linear model | |
| Comments | Treatment as a fixed effect | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 6.8 | |
| Confidence Interval |
() 95% -3.7 to 17.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.808 |
| Comments | Analysis of Global Satisfaction | |
| Method | Generalized linear model | |
| Comments | Treatment as a fixed effect | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.3 | |
| Confidence Interval |
() 95% -9.2 to 11.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.371 |
| Comments | Analysis of Global Satisfaction | |
| Method | Generalized linear model | |
| Comments | Treatment as a fixed effect | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 5.5 | |
| Confidence Interval |
() 95% -6.6 to 17.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | First Perceptible Relief |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population Number of subjects assessed at each hour is: N = Celecoxib 50mg/50mg, Celecoxib 100mg/Placebo, Celecoxib 100mg/50mg, Placebo |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg/Placebo | Celecoxib 100mg/50mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | ||||
| Measure Participants | 90 | 45 | 45 | 89 |
| 1 hour - Onset subjects in hour |
68
|
29
|
22
|
40
|
| 1 hour - No onset subjects in hour |
22
|
16
|
23
|
49
|
| 2 hour - Onset subjects in hour |
13
|
10
|
9
|
11
|
| 2 hour-No onset subjects in hour |
9
|
6
|
14
|
38
|
| 3 hour - Onset subjects in hour |
1
|
2
|
0
|
2
|
| 3 hour-No onset subjects in hour |
8
|
4
|
14
|
36
|
| 4 hour - Onset subjects in hour |
0
|
0
|
2
|
4
|
| 4 hour- No onset subjects in hour |
8
|
4
|
12
|
32
|
| 5 hour - Onset subjects in hour |
0
|
0
|
1
|
4
|
| 5 hour-No onset subjects in hour |
8
|
4
|
11
|
28
|
| 6 hour - Onset subjects in hour |
0
|
1
|
3
|
1
|
| 6 hour-No onset subjects in hour |
8
|
3
|
8
|
27
|
| 7 hour - Onset subjects in hour |
0
|
0
|
1
|
1
|
| 7 hour-No onset subjects in hour |
8
|
3
|
7
|
26
|
| 8 hour - Onset subjects in hour |
0
|
0
|
1
|
2
|
| 8 hour-No onset subjects in hour |
8
|
3
|
6
|
24
|
| 9 hour - Onset subjects in hour |
2
|
0
|
0
|
2
|
| 9 hour-No onset subjects in hour |
6
|
3
|
6
|
22
|
| 10 hour - Onset subjects in hour |
0
|
0
|
0
|
0
|
| 10 hour-No onset subjects in hour |
6
|
3
|
6
|
22
|
| 11 hour - Onset subjects in hour |
0
|
0
|
0
|
1
|
| 11 hour-No onset subjects in hour ( |
6
|
3
|
6
|
21
|
| 12 hour - Onset subjects in hour |
0
|
0
|
0
|
1
|
| 12 hour-No onset subjects in hour |
6
|
3
|
6
|
20
|
| 24 hour - Onset subjects in hour |
1
|
0
|
0
|
2
|
| 24 hour-No onset subjects in hour |
5
|
3
|
6
|
18
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Based on life-table extension of Mantel-Haenszel method. p-value for general association | |
| Method | Mantel Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | Based on life-table extension of Mantel-Haenszel method. p-value for general association | |
| Method | Mantel Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.235 |
| Comments | Based on life-table extension of Mantel-Haenszel method. p-value for general association | |
| Method | Mantel Haenszel | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.012 |
| Comments | Based on life-table extension of Mantel-Haenszel method. p-value for general association | |
| Method | Mantel Haenszel | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.438 |
| Comments | Based on life-table extension of Mantel-Haenszel method. p-value for general association | |
| Method | Mantel Haenszel | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.067 |
| Comments | Based on life-table extension of Mantel-Haenszel method. p-value for general association | |
| Method | Mantel Haenszel | |
| Comments | ||
| Title | No Perceptible Relief |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population Number of subjects at each time point (in hour) is: N = Celecoxib 50mg/50mg, Celecoxib 100mg/Placebo, Celecoxib 100mg/50mg, Placebo |
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg/Placebo | Celecoxib 100mg/50mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | ||||
| Measure Participants | 90 | 45 | 45 | 89 |
| 1 hour - Offset subjects in hour |
0
|
0
|
0
|
0
|
| 1 hour-No offset subjects in hour |
90
|
45
|
45
|
89
|
| 2 hour- Offset subjects in hour |
0
|
1
|
0
|
1
|
| 2 hour-No offset subjects in hr |
90
|
44
|
45
|
88
|
| 3 hour- Offset subjects in hour |
1
|
0
|
1
|
0
|
| 3 hour-No offset subjects in hr |
89
|
44
|
44
|
88
|
| 4 hour- Offset subjects in hour |
0
|
0
|
0
|
0
|
| 4 hour-No offset subjects in hr |
89
|
44
|
44
|
88
|
| 5 hour- Offset subjects in hour |
1
|
0
|
0
|
0
|
| 5 hour-No offset subjects in hr |
88
|
44
|
44
|
88
|
| 6 hour- Offset subjects in hour |
0
|
0
|
0
|
1
|
| 6 hour-No offset subjects in hr |
88
|
44
|
44
|
87
|
| 7 hour- Offset subjects in hour |
4
|
2
|
2
|
1
|
| 7 hour-No offset subjects in hr |
84
|
42
|
42
|
86
|
| 8 hour- Offset subjects in hour |
1
|
2
|
0
|
0
|
| 8 hour-No offset subjects in hr |
83
|
40
|
42
|
86
|
| 9 hour- Offset subjects in hour |
1
|
3
|
1
|
0
|
| 9 hour-No offset subjects in hr |
82
|
37
|
41
|
86
|
| 10 hour-Offset subjects in hour |
2
|
0
|
0
|
3
|
| 10 hour-No offset subjects in hr |
80
|
37
|
41
|
83
|
| 11 hour-Offset subjects in hour |
1
|
0
|
0
|
0
|
| 11 hour-No offset subjects in hr |
79
|
37
|
41
|
83
|
| 12 hour-Offset subjects in hour |
1
|
0
|
0
|
2
|
| 12 hour-No offset subjects in hr |
78
|
37
|
41
|
81
|
| 24 hour-Offset subjects in hour (N=78,37, 41, 81) |
3
|
0
|
3
|
0
|
| 24 hour-No offset subjects in hr (N=78,37,41, 81) |
75
|
37
|
38
|
81
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.128 |
| Comments | Based on life-table extension of Mantel-Haenszel method. p-value for general association | |
| Method | Mantel Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.123 |
| Comments | Based on life-table extension of Mantel-Haenszel method. p-value for general association | |
| Method | Mantel Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.266 |
| Comments | Based on life-table extension of Mantel-Haenszel method. p-value for general association | |
| Method | Mantel Haenszel | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.849 |
| Comments | Based on life-table extension of Mantel-Haenszel method. p-value for general association | |
| Method | Mantel Haenszel | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib 100mg (Pooled), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.828 |
| Comments | Based on life-table extension of Mantel-Haenszel method. p-value for general association | |
| Method | Mantel Haenszel | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.741 |
| Comments | Based on life-table extension of Mantel-Haenszel method. p-value for general association | |
| Method | Mantel Haenszel | |
| Comments | ||
Adverse Events
| Time Frame | Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days) | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set. | |||||||
| Arm/Group Title | Celecoxib 50mg/50mg | Celecoxib 100mg/Placebo | Celecoxib 100mg/50mg | Placebo | ||||
| Arm/Group Description | Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg | Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo | Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg | Dose 1 placebo followed 6-12 hours later by dose 2 placebo | ||||
All Cause Mortality |
||||||||
| Celecoxib 50mg/50mg | Celecoxib 100mg/Placebo | Celecoxib 100mg/50mg | Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/90 (0%) | 0/45 (0%) | 0/45 (0%) | 0/89 (0%) | ||||
Serious Adverse Events |
||||||||
| Celecoxib 50mg/50mg | Celecoxib 100mg/Placebo | Celecoxib 100mg/50mg | Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/90 (0%) | 0/45 (0%) | 0/45 (0%) | 0/89 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Celecoxib 50mg/50mg | Celecoxib 100mg/Placebo | Celecoxib 100mg/50mg | Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/90 (8.9%) | 5/45 (11.1%) | 5/45 (11.1%) | 6/89 (6.7%) | ||||
| Eye disorders | ||||||||
| Conjunctivitis | 1/90 (1.1%) | 0/45 (0%) | 1/45 (2.2%) | 1/89 (1.1%) | ||||
| Gastrointestinal disorders | ||||||||
| Dyspepsia | 0/90 (0%) | 0/45 (0%) | 0/45 (0%) | 2/89 (2.2%) | ||||
| Nausea | 3/90 (3.3%) | 2/45 (4.4%) | 0/45 (0%) | 1/89 (1.1%) | ||||
| Abdominal distension | 0/90 (0%) | 1/45 (2.2%) | 0/45 (0%) | 0/89 (0%) | ||||
| General disorders | ||||||||
| Fatigue | 1/90 (1.1%) | 1/45 (2.2%) | 0/45 (0%) | 0/89 (0%) | ||||
| Feeling abnormal | 0/90 (0%) | 0/45 (0%) | 1/45 (2.2%) | 0/89 (0%) | ||||
| Infections and infestations | ||||||||
| Otitis media | 0/90 (0%) | 0/45 (0%) | 1/45 (2.2%) | 1/89 (1.1%) | ||||
| Viral rash | 0/90 (0%) | 0/45 (0%) | 1/45 (2.2%) | 0/89 (0%) | ||||
| Nervous system disorders | ||||||||
| Dizziness | 2/90 (2.2%) | 0/45 (0%) | 0/45 (0%) | 1/89 (1.1%) | ||||
| Headache | 2/90 (2.2%) | 0/45 (0%) | 0/45 (0%) | 0/89 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Wheezing | 0/90 (0%) | 0/45 (0%) | 1/45 (2.2%) | 1/89 (1.1%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Rash generalized | 0/90 (0%) | 1/45 (2.2%) | 1/45 (2.2%) | 0/89 (0%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.govCallCenter@pfizer.com |
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00402987
Other Study ID Numbers:
- A3191334
First Posted:
Nov 23, 2006
Last Update Posted:
Mar 3, 2021
Last Verified:
Mar 1, 2021