Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat
- Registration Number
- NCT00402987
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 269
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description celecoxib 50 mg/50 mg celecoxib - celecoxib 100 mg/placebo celecoxib - Placebo placebo - celecoxib 100 mg/50 mg celecoxib -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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) 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.
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.
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 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)
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.
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
Trial Locations
- Locations (1)
University of Connecticut Student Health Services
🇺🇸Storrs, Connecticut, United States