A Comparison Of Valdecoxib 20 Mg Twice Daily and 40 Mg Daily and Placebo In The Treatment Of Sore Throat
- Registration Number
- NCT00647829
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 197
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 valdecoxib - Arm 3 placebo - Arm 2 valdecoxib -
- Primary Outcome Measures
Name Time Method Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing 2-hour period after the first dose
- Secondary Outcome Measures
Name Time Method 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 Sum of Sore Throat Relief Rating (SSTRR) on swallowing 2, 4, 6, 8, 10, 12, and 24 hours after 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 Patient's satisfaction with treatment 24-hour period after the first dose Sore Throat Pain Intensity Difference (PID, VAS) on swallowing each post dose time point Time to perceptible pain relief 2-hour period after the first dose Time to meaningful pain relief 2-hour period after the first dose
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Boca Raton, Florida, United States