Clinical Trial: A Comparison Of Valdecoxib 20 Mg Twice Daily and 40 Mg Daily and Placebo In The Treatment Of Sore Throat

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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,

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 Summary:
Sponsor: Pfizer

Current Primary Outcome: Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing [ Time Frame: 2-hour period after the first dose ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing [ Time Frame: 4, 6, 8, 10, 12, and 24 hours after first dose ]
  • Peak Sore Throat Pain Intensity Difference (PPID) on swallowing [ Time Frame: 24-hour period after the first dose ]
  • Throat Soreness Difference (TSD) on swallowing [ Time Frame: each post dose time point ]
  • Sum of Throat Soreness Difference (STSD) on swallowing [ Time Frame: 2, 4, 6, 8, 10, 12, and 24 hours after first dose ]
  • Peak Throat Soreness Difference (PTSD) on swallowing [ Time Frame: 24-hour period after the first dose ]
  • Sum of Sore Throat Relief Rating (SSTRR) on swallowing [ Time Frame: 2, 4, 6, 8, 10, 12, and 24 hours after first dose ]
  • Peak Sore Throat Relief Rating (PSTRR) on swallowing [ Time Frame: 24-hour period after the first dose ]
  • Time to onset of analgesia [ Time Frame: 2-hour period after the first dose ]
  • Time to rescue medication [ Time Frame: 24-hour period after the first dose ]
  • Patient's global evaluation of study medication [ Time Frame: 24-hour period after the first dose ]
  • Percent of patients taking rescue medications [ Time Frame: 24-hour period after the first dose ]
  • Sore Throat Relief Rating (STRR) on swallowing [ Time Frame: post dose time point ]
  • Patient's satisfaction with treatment [ Time Frame: 24-hour period after the first dose ]
  • Sore Throat Pain Intensity Difference (PID, VAS) on swallowing [ Time Frame: each post dose time point ]
  • Time to perceptible pain relief [ Time Frame: 2-hour period after the first dose ]
  • Time to meaningful pain relief [ Time Frame: 2-hour period after the first dose ]


Original Secondary Outcome: Same as current

Information By: Pfizer

Dates:
Date Received: March 27, 2008
Date Started: February 2003
Date Completion:
Last Updated: April 23, 2008
Last Verified: April 2008