Status:
COMPLETED
A Comparison Of Valdecoxib 20 Mg Twice Daily and 40 Mg Daily and Placebo In The Treatment Of Sore Throat
Lead Sponsor:
Pfizer
Conditions:
Pharyngitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2003
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT00647829
Start Date
February 1 2003
End Date
December 1 2003
Last Update
April 24 2008
Active Locations (2)
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1
Pfizer Investigational Site
Storrs, Connecticut, United States, 06269-2011
2
Pfizer Investigational Site
Boca Raton, Florida, United States, 33433