Pharyngitis
Conditions
Keywords
pharyngitis, sore throat
Brief summary
The study was performed to evaluate the analgesic efficacy, safety, and tolerability of valdecoxib 20 mg twice daily (BID), valdecoxib 40 mg once daily (QD), and placebo in patients with moderately to severely painful symptomatic sore throat over a 24-hour period. In addition, the study was to validate a new scale and criteria for measuring pain in sore throat and evaluate the effects of selective serotonin reuptake inhibitors and past sore throat pain on pain score and efficacy of analgesics. The study also examined what type of medications are commonly used for sore throat and whether this information has relevance to analgesic efficacy.
Interventions
DRUGvaldecoxib
valdecoxib 20 mg tablet by mouth twice daily (BID) for 2 doses over a 24-hour period
DRUGplacebo
placebo tablet by mouth for 2 doses over a 24-hour period
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Included patients had moderate to severe pain, as measured by the Sore Throat Pain Intensity Scale (STPIS) on swallowing ≥66 mm on a 100-mm visual analogue scale (VAS) and a minimum of 4 points on the 10-point Tonsillo-Pharyngitis Score (TPS) but who were not coughing or experiencing any evidence of mouth-breathing.
Exclusion criteria
* Patients who used throat lozenges, throat spray, cough drops or menthol-containing products within 2 hours, short-acting analgesics/antipyretics (eg, ibuprofen) or any form of cold medication within 8 hours, antibiotics for acute disease within 24 hours of first dose of study medication, or presumed diagnosis of infectious mononucleosis, known allergy or hypersensitivity to NSAIDs, COX-2 specific inhibitors, sulfonamides, or acetaminophen were excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing | 2-hour period after the first dose |
Secondary
| Measure | Time frame |
|---|---|
| Time to perceptible pain relief | 2-hour period after the first dose |
| Patient's satisfaction with treatment | 24-hour period after the first dose |
| Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing | 4, 6, 8, 10, 12, and 24 hours after first dose |
| Peak Sore Throat Pain Intensity Difference (PPID) on swallowing | 24-hour period after the first dose |
| Throat Soreness Difference (TSD) on swallowing | each post dose time point |
| Sum of Throat Soreness Difference (STSD) on swallowing | 2, 4, 6, 8, 10, 12, and 24 hours after first dose |
| Peak Throat Soreness Difference (PTSD) on swallowing | 24-hour period after the first dose |
| Sore Throat Pain Intensity Difference (PID, VAS) on swallowing | each post dose time point |
| Time to meaningful pain relief | 2-hour period after the first dose |
| Peak Sore Throat Relief Rating (PSTRR) on swallowing | 24-hour period after the first dose |
| Time to onset of analgesia | 2-hour period after the first dose |
| Time to rescue medication | 24-hour period after the first dose |
| Patient's global evaluation of study medication | 24-hour period after the first dose |
| Percent of patients taking rescue medications | 24-hour period after the first dose |
| Sore Throat Relief Rating (STRR) on swallowing | post dose time point |
| Sum of Sore Throat Relief Rating (SSTRR) on swallowing | 2, 4, 6, 8, 10, 12, and 24 hours after first dose |
Countries
United States
Outcome results
None listed