A Comparison Of Valdecoxib 20 Mg Twice Daily and 40 Mg Daily and Placebo In The Treatment Of Sore Throat
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pharyngitis
Intervention: valdecoxib (Drug); valdecoxib (Drug); placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: Clinical Protocol For A Double-Blind, Randomized, Placebo-Controlled Comparison Of The Efficacy, Safety, And Tolerability Of Bextra® (Valdecoxib) 20 Mg Twice Daily, Bextra® 40 Mg Once Daily, And Placebo In The Symptomatic Treatment Of Subjects With Pharyngitis
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing
Secondary outcome: Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowingPeak Sore Throat Pain Intensity Difference (PPID) on swallowing Throat Soreness Difference (TSD) on swallowing Sum of Throat Soreness Difference (STSD) on swallowing Peak Throat Soreness Difference (PTSD) on swallowing Sum of Sore Throat Relief Rating (SSTRR) on swallowing Peak Sore Throat Relief Rating (PSTRR) on swallowing Time to onset of analgesia Time to rescue medication Patient's global evaluation of study medication Percent of patients taking rescue medications Sore Throat Relief Rating (STRR) on swallowing Patient's satisfaction with treatment Sore Throat Pain Intensity Difference (PID, VAS) on swallowing Time to perceptible pain relief Time to meaningful pain relief
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Pfizer Investigational Site, STORRS, Connecticut 06269-2011, United States
Pfizer Investigational Site, BOCA RATON, Florida 33433, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: February 2003
Ending date: December 2003
Last updated: April 23, 2008
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