Trial · NCT00402987

Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat

NCT00402987, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2009-03-12

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat. Trials, record NCT00402987. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00402987

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat
NCT number: NCT00402987
Status: Completed
Phases: Phase 3
Enrollment: 269 participants, actual
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions: Pharyngitis
Interventions: Celecoxib, Celecoxib, celecoxib, placebo
First posted: 2006-11-23
Last updated: 2021-03-03
Results first posted: 2009-03-12

Source ClinicalTrials.gov

Registered outcomes45

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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).
Secondary	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).
Secondary	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

1 to 10 of 45Source ClinicalTrials.gov

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Outcomes45

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose	2 hours Post-First Dose	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.	units on a scale * hours	LEAST_SQUARES_MEAN
SECONDARY	Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose	Within First 6 hours Post-First Dose	Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.~MITT population	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose	7 to 24 hours	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	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose	up to 6 hours	Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.~MITT population	units on a scale * hours	LEAST_SQUARES_MEAN
SECONDARY	Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose	7 to 24 hours	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	units on a scale * hours	LEAST_SQUARES_MEAN
SECONDARY	Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose	within the first 6 hours	Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.~MITT population	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose	7 to 24 hours	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	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 6 Hours Post-First Dose	at 6 hours	MITT population	subjects	NUMBER
SECONDARY	Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 12 Hours Post-First Dose	12 hours	MITT population	subjects	NUMBER
SECONDARY	Time to Perceptible Pain Relief	Within 2 Hours Post-First Dose	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	minutes	MEDIAN

1 to 10 of 45Source ClinicalTrials.gov

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Results by group876

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose	Celecoxib 100mg (Pooled)		21.0	Standard Error 2.20	units on a scale * hours
Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose	Placebo		9.4	Standard Error 2.21	units on a scale * hours
Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose	Celecoxib 50mg/50mg	15 min	1.62	Standard Error 0.64	units on a scale
Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose	Celecoxib 100mg (Pooled)	15 min	1.92	Standard Error 0.64	units on a scale
Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose	Placebo	15 min	0.40	Standard Error 0.64	units on a scale
Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose	Celecoxib 50mg/50mg	30 min	4.70	Standard Error 0.90	units on a scale
Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose	Celecoxib 100mg (Pooled)	30 min	4.93	Standard Error 0.90	units on a scale
Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose	Placebo	30 min	2.14	Standard Error 0.91	units on a scale
Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose	Celecoxib 50mg/50mg	45 min	9.57	Standard Error 1.22	units on a scale
Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose	Celecoxib 100mg (Pooled)	45 min	7.05	Standard Error 1.23	units on a scale

1 to 10 of 876Source ClinicalTrials.gov

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Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Celecoxib 50mg/50mg	90
Overall Study	STARTED	Celecoxib 100mg/Placebo	45
Overall Study	STARTED	Celecoxib 100mg/50mg	45
Overall Study	STARTED	Placebo	89
Overall Study	COMPLETED	Celecoxib 50mg/50mg	90
Overall Study	COMPLETED	Celecoxib 100mg/Placebo	45
Overall Study	COMPLETED	Celecoxib 100mg/50mg	44
Overall Study	COMPLETED	Placebo	89
Overall Study	NOT COMPLETED	Celecoxib 50mg/50mg	0
Overall Study	NOT COMPLETED	Celecoxib 100mg/Placebo	0

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Adverse events48

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Conjunctivitis	Eye disorders	Celecoxib 50mg/50mg	1	90
other	Conjunctivitis	Eye disorders	Celecoxib 100mg/Placebo	0	45
other	Conjunctivitis	Eye disorders	Celecoxib 100mg/50mg	1	45
other	Conjunctivitis	Eye disorders	Placebo	1	89
other	Dyspepsia	Gastrointestinal disorders	Celecoxib 50mg/50mg	0	90
other	Dyspepsia	Gastrointestinal disorders	Celecoxib 100mg/Placebo	0	45
other	Dyspepsia	Gastrointestinal disorders	Celecoxib 100mg/50mg	0	45
other	Dyspepsia	Gastrointestinal disorders	Placebo	2	89
other	Nausea	Gastrointestinal disorders	Celecoxib 50mg/50mg	3	90
other	Nausea	Gastrointestinal disorders	Celecoxib 100mg/Placebo	2	45

1 to 10 of 48Source ClinicalTrials.gov

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Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Celecoxib 50mg/50mg	0	90
Total, all-cause mortality	Celecoxib 100mg/Placebo	0	45
Total, all-cause mortality	Celecoxib 100mg/50mg	0	45
Total, all-cause mortality	Placebo	0	89
Total, other adverse events	Celecoxib 50mg/50mg	8	90
Total, other adverse events	Celecoxib 100mg/Placebo	5	45
Total, other adverse events	Celecoxib 100mg/50mg	5	45
Total, other adverse events	Placebo	6	89
Total, serious adverse events	Celecoxib 50mg/50mg	0	90
Total, serious adverse events	Celecoxib 100mg/Placebo	0	45

1 to 10 of 12Source ClinicalTrials.gov

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Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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