Phase 3
N=269
Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat
Pharyngitis
Bottom Line
View on ClinicalTrials.gov: NCT00402987 ↗Enrolled (actual)
269
Serious AEs
0.0%
Results posted
Mar 2009
Primary outcome: Primary: Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose — 21.0; 9.4 units on a scale * hours — p=0.0003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Celecoxib (Drug); placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Nov 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose |
21.0; 9.4 | 0.0003 sig |
| SECONDARY Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose |
1.62; 1.92; 0.40; 4.70; 4.93; 2.14 | 0.212 |
| SECONDARY Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose |
20.82; 22.01; 18.34; 9.32; 20.39; 20.81 | 0.001 sig |
| SECONDARY Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose |
0.2; 0.2; 0.1; 1.0; 1.1; 0.4 | 0.180 |
| SECONDARY Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose |
149.2; 151.8; 111.6; 56.6; 169.8; 173.2 | <0.001 sig |
| SECONDARY Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose |
0.12; 0.09; 0.16; 0.41; 0.34; 0.34 | 0.537 |
| SECONDARY Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose |
1.71; 2.00; 1.67; 0.93; 1.68; 1.80 | 0.001 sig |
| SECONDARY Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 6 Hours Post-First Dose |
28; 31; 13 | 0.010 sig |
| SECONDARY Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 12 Hours Post-First Dose |
21; 13; 12; 14 | 0.202 |
| SECONDARY Time to Perceptible Pain Relief |
49; 61; 97 | <0.05 sig |
| SECONDARY Time to Meaningful Pain Relief |
36; 33; 15 | <0.05 sig |
| SECONDARY Time to Onset of Analgesia |
36; 34; 15 | <0.05 sig |
| SECONDARY Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose |
5; 4; 2; 24; 25; 5 | <0.001 sig |
| SECONDARY Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose |
8; 5; 0; 1; 23; 10 | <0.001 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00402987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.