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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: valdecoxib
  • valdecoxib 20 mg tablet by mouth twice daily (BID) for 2 doses over a 24-hour period
• Drug: valdecoxib
  • valdecoxib 40 mg tablet by mouth once daily (QD) for 2 doses over a 24-hour period
• Drug: placebo
  • placebo tablet by mouth for 2 doses over a 24-hour period

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Arm 1
• Active Comparator: Arm 2
• Placebo Comparator: Arm 3

Primary Measures

• Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing
  • Time Frame: 2-hour period after the first dose
    Safety Issue?: No

Secondary Measures

• Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing
  • Time Frame: 4, 6, 8, 10, 12, and 24 hours after first dose
    Safety Issue?: No
• Peak Sore Throat Pain Intensity Difference (PPID) on swallowing
  • Time Frame: 24-hour period after the first dose
    Safety Issue?: No
• Throat Soreness Difference (TSD) on swallowing
  • Time Frame: each post dose time point
    Safety Issue?: No
• Sum of Throat Soreness Difference (STSD) on swallowing
  • Time Frame: 2, 4, 6, 8, 10, 12, and 24 hours after first dose
    Safety Issue?: No
• Peak Throat Soreness Difference (PTSD) on swallowing
  • Time Frame: 24-hour period after the first dose
    Safety Issue?: No
• Sum of Sore Throat Relief Rating (SSTRR) on swallowing
  • Time Frame: 2, 4, 6, 8, 10, 12, and 24 hours after first dose
    Safety Issue?: No
• Peak Sore Throat Relief Rating (PSTRR) on swallowing
  • Time Frame: 24-hour period after the first dose
    Safety Issue?: No
• Time to onset of analgesia
  • Time Frame: 2-hour period after the first dose
    Safety Issue?: No
• Time to rescue medication
  • Time Frame: 24-hour period after the first dose
    Safety Issue?: No
• Patient's global evaluation of study medication
  • Time Frame: 24-hour period after the first dose
    Safety Issue?: No
• Percent of patients taking rescue medications
  • Time Frame: 24-hour period after the first dose
    Safety Issue?: No
• Sore Throat Relief Rating (STRR) on swallowing
  • Time Frame: post dose time point
    Safety Issue?: No
• Patient's satisfaction with treatment
  • Time Frame: 24-hour period after the first dose
    Safety Issue?: No
• Sore Throat Pain Intensity Difference (PID, VAS) on swallowing
  • Time Frame: each post dose time point
    Safety Issue?: No
• Time to perceptible pain relief
  • Time Frame: 2-hour period after the first dose
    Safety Issue?: No
• Time to meaningful pain relief
  • Time Frame: 2-hour period after the first dose
    Safety Issue?: 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00647829

Study ID Number: A3471026

ClinicalTrials.gov Identifier: NCT00647829

Health Authority: United States: Institutional Review Board

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