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Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat

Primary Purpose

Pharyngitis

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Celecoxib

celecoxib

placebo

About this trial

This is an interventional treatment trial for Pharyngitis focused on measuring sore throat, acute pain

Eligibility Criteria

18 Years - 18 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Connecticut Student Health Services

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

celecoxib 50 mg/50 mg

celecoxib 100 mg/placebo

celecoxib 100 mg/50 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose

Based on the Pain Intensity scores measured on a Visual Analogue Scale (PI-VAS: 0mm=no pain,100mm=worst possible pain), assessed by the subjects, the SPID2 is the area under the curve (AUC) over the 2-hour period post-first dose of the Pain Intensity Difference (PID) scores using the trapezoidal rule.

Secondary Outcome Measures

Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose

Pain intensity (PI) on Swallowing as Measured by PI-VAS scale: 0mm=no pain, 100mm=worst possible pain. Sore throat PID score was obtained by subtracting the PI at each time point from the Baseline PI score. Increase in scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain.

Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose

Pain intensity (PI) on Swallowing as Measured by PI-VAS scale: 0mm=no pain, 100mm=worst possible pain. PID score was obtained by subtracting the PI at each time point from the Baseline PI score. An increase in scores indicated a lessening of subjects' pain as compared to Baseline scores, thus, higher scores indicated a greater reduction in pain.

Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose

The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The PID [based on PI-VAS scale: 0mm=no pain, 100mm=worst possible pain] was calculated as the difference between the pain intensity at the time and at baseline.

Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose

Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose

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

Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose

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

Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 6 Hours Post-First Dose

Subjects Achieving at Least 'Moderate Relief' as Measured by STRRS (range: 0=no relief to 6=complete relief); Moderate relief is defined as STRRS = 3).

Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 12 Hours Post-First Dose

Subjects Achieving at Least 'Moderate Relief' as Measured by STRRS (range: 0=no relief to 6=complete relief); Moderate relief is defined as STRRS = 3).

Time to Perceptible Pain Relief

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

Time to Meaningful Pain Relief

The time (measured by stopwatch) when the subject felt their pain relief was meaningful to them was not estimable thus the number of subjects experiencing meaningful pain relief within 2 hours of first dose is reported

Time to Onset of Analgesia

Equal to time of perceptible pain relief when both perceptible pain relief and meaningful pain relief were experienced- the median time was not estimable thus the number of subjects with onset of analgesia within 2 hours of first dose is reported

Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose

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

Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose

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

Full Information

NCT ID

NCT00402987

First Posted

November 21, 2006

Last Updated

March 1, 2021

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00402987

Brief Title

Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

December 4, 2006 (Actual)

Primary Completion Date

November 15, 2007 (Actual)

Study Completion Date

November 15, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pharyngitis

Keywords

sore throat, acute pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

269 (Actual)

8. Arms, Groups, and Interventions

Arm Title

celecoxib 50 mg/50 mg

Arm Type

Experimental

Arm Title

celecoxib 100 mg/placebo

Arm Type

Experimental

Arm Title

celecoxib 100 mg/50 mg

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Celecoxib

Intervention Description

dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg

Intervention Type

Drug

Intervention Name(s)

Celecoxib

Intervention Description

dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo

Intervention Type

Drug

Intervention Name(s)

celecoxib

Intervention Description

dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

dose 1 placebo followed 6-12 hours later by dose 2 placebo

Primary Outcome Measure Information:

Title

Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose

Description

Time Frame

2 hours Post-First Dose

Secondary Outcome Measure Information:

Title

Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose

Description

Time Frame

Within First 6 hours Post-First Dose

Title

Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose

Description

Time Frame

7 to 24 hours

Title

Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose

Description

Time Frame

up to 6 hours

Title

Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose

Description

Time Frame

7 to 24 hours

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

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

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

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

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

Title

Time to Meaningful Pain Relief

Description

Time Frame

Within 2 Hours Post-First Dose

Title

Time to Onset of Analgesia

Description

Time Frame

Within 2 Hours Post-First Dose

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

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

Other Pre-specified Outcome Measures:

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

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

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

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

Title

Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose

Description

Time Frame

7 to 24 hours Post-First Dose

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

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

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

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

Title

Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose

Description

Time Frame

7 to 24 hours Post-First Dose

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

Title

Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 12 Hours Post-First Dose

Description

Time Frame

At 12 Hours

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

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

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

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

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

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

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

Title

Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 12 Hours Post-First Dose

Description

Time Frame

12 hours Post-First Dose

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

Title

Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose

Description

Time Frame

12 hours Post-First Dose

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

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

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

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

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

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

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

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

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

University of Connecticut Student Health Services

City

Storrs

State/Province

Connecticut

ZIP/Postal Code

06269-2011

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3191334&StudyName=Testing%20The%20Effectiveness%20Of%20Celecoxib%20In%20Patients%20With%20Painful%20Sore%20Throat

Description

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Learn more about this trial

Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat

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