Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pharyngitis

Intervention / Treatment
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* Drug: Celecoxib
* Drug: Celecoxib
* Drug: celecoxib
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: celecoxib 50 mg/50 mg<br> | Drug: Celecoxib<br>* dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg<br>|
| Experimental: celecoxib 100 mg/placebo<br> | Drug: Celecoxib<br>* dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo<br>|
| Experimental: celecoxib 100 mg/50 mg<br> | Drug: celecoxib<br>* dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* dose 1 placebo followed 6-12 hours later by dose 2 placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 hours Post-First Dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within First 6 hours Post-First Dose | 
| 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. | 7 to 24 hours | 
| 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. | up to 6 hours | 
| Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose | The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The PID [based on PI-VAS scale: 0mm=no pain, 100mm=worst possible pain] was calculated as the difference between the pain intensity at the time and at baseline. | 7 to 24 hours | 
| 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. | within the first 6 hours | 
| 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. | 7 to 24 hours | 
| 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). | at 6 hours | 
| 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). | 12 hours | 
| Time to Perceptible Pain Relief | Defined as time (measured by stopwatch) when subject began to feel any pain relieving effect from the drug | Within 2 Hours Post-First Dose | 
| 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 | Within 2 Hours Post-First Dose | 
| 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 | Within 2 Hours Post-First Dose | 
| 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) | 6 Hours Post-First Dose | 
| 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) | 12 and 24 hours Post-First Dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sore throat, acute pain