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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
269
University of Connecticut Student Health Services
Storrs, Connecticut, United States
Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose
Based on the Pain Intensity scores measured on a Visual Analogue Scale (PI-VAS: 0mm=no pain,100mm=worst possible pain), assessed by the subjects, the SPID2 is the area under the curve (AUC) over the 2-hour period post-first dose of the Pain Intensity Difference (PID) scores using the trapezoidal rule.
Time frame: 2 hours Post-First Dose
Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose
Pain intensity (PI) on Swallowing as Measured by PI-VAS scale: 0mm=no pain, 100mm=worst possible pain. Sore throat PID score was obtained by subtracting the PI at each time point from the Baseline PI score. Increase in scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain.
Time frame: Within First 6 hours Post-First Dose
Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose
Pain intensity (PI) on Swallowing as Measured by PI-VAS scale: 0mm=no pain, 100mm=worst possible pain. PID score was obtained by subtracting the PI at each time point from the Baseline PI score. An increase in scores indicated a lessening of subjects' pain as compared to Baseline scores, thus, higher scores indicated a greater reduction in pain.
Time frame: 7 to 24 hours
Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose
The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The PID \[based on PI-VAS scale: 0mm=no pain, 100mm=worst possible pain\] was calculated as the difference between the pain intensity at the time and at baseline.
Time frame: up to 6 hours
Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose
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dose 1 placebo followed 6-12 hours later by dose 2 placebo
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
Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose
STRRS score (scale: 0 no relief to 6 complete relief); a higher pain score indicated a greater reduction in pain.
Time frame: within the first 6 hours
Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose
STRRS score (scale: 0 no relief to 6 complete relief); a higher score indicated a greater reduction in pain.
Time frame: 7 to 24 hours
Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 6 Hours Post-First Dose
Subjects Achieving at Least 'Moderate Relief' as Measured by STRRS (range: 0=no relief to 6=complete relief); Moderate relief is defined as STRRS = 3).
Time frame: at 6 hours
Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 12 Hours Post-First Dose
Subjects Achieving at Least 'Moderate Relief' as Measured by STRRS (range: 0=no relief to 6=complete relief); Moderate relief is defined as STRRS = 3).
Time frame: 12 hours
Time to Perceptible Pain Relief
Defined as time (measured by stopwatch) when subject began to feel any pain relieving effect from the drug
Time frame: Within 2 Hours Post-First Dose
Time to Meaningful Pain Relief
The time (measured by stopwatch) when the subject felt their pain relief was meaningful to them was not estimable thus the number of subjects experiencing meaningful pain relief within 2 hours of first dose is reported
Time frame: Within 2 Hours Post-First Dose
Time to Onset of Analgesia
Equal to time of perceptible pain relief when both perceptible pain relief and meaningful pain relief were experienced- the median time was not estimable thus the number of subjects with onset of analgesia within 2 hours of first dose is reported
Time frame: Within 2 Hours Post-First Dose
Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose
Subject assessment of overall impression of study drug on 4 point scale from 1 (poor) to 4 (excellent)
Time frame: 6 Hours Post-First Dose
Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose
Subject assessment of overall impression of study drug on 4 point scale from 1 (poor) to 4 (excellent)
Time frame: 12 and 24 hours Post-First Dose