NCT00647829

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pharyngitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2003-02-01
• Completion: 2003-12-01
• First posted: 2008-04-01
• Last updated: 2008-04-24

Locations

2 sites across 1 country: United States