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NCT00647829 Clinical Trial

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

Pharyngitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00647829
Other study ID # A3471026
Secondary ID
Status Completed
Phase Phase 3
First received March 27, 2008
Last updated April 23, 2008
Start date February 2003
Est. completion date December 2003

Study information
Verified date April 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 197
Est. completion date December 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Pfizer Investigational Site Boca Raton Florida
United States Pfizer Investigational Site Storrs Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

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