Clinical trial NCT00647829: A Comparison Of Valdecoxib 20 Mg Twice Daily and 40 Mg Daily and Placebo In The Treatment Of Sore Throat
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pharyngitis
Keywords: pharyngitis, sore throat
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing
timeFrame: 2-hour period after the first dose
Secondary outcomes:
measure: Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing
timeFrame: 4, 6, 8, 10, 12, and 24 hours after first dose
measure: Peak Sore Throat Pain Intensity Difference (PPID) on swallowing
timeFrame: 24-hour period after the first dose
measure: Throat Soreness Difference (TSD) on swallowing
timeFrame: each post dose time point
measure: Sum of Throat Soreness Difference (STSD) on swallowing
timeFrame: 2, 4, 6, 8, 10, 12, and 24 hours after first dose
measure: Peak Throat Soreness Difference (PTSD) on swallowing
timeFrame: 24-hour period after the first dose
measure: Sum of Sore Throat Relief Rating (SSTRR) on swallowing
timeFrame: 2, 4, 6, 8, 10, 12, and 24 hours after first dose
measure: Peak Sore Throat Relief Rating (PSTRR) on swallowing
timeFrame: 24-hour period after the first dose
measure: Time to onset of analgesia
timeFrame: 2-hour period after the first dose
measure: Time to rescue medication
timeFrame: 24-hour period after the first dose
measure: Patient's global evaluation of study medication
timeFrame: 24-hour period after the first dose
measure: Percent of patients taking rescue medications
timeFrame: 24-hour period after the first dose
measure: Sore Throat Relief Rating (STRR) on swallowing
timeFrame: post dose time point
measure: Patient's satisfaction with treatment
timeFrame: 24-hour period after the first dose
measure: Sore Throat Pain Intensity Difference (PID, VAS) on swallowing
timeFrame: each post dose time point
measure: Time to perceptible pain relief
timeFrame: 2-hour period after the first dose
measure: Time to meaningful pain relief
timeFrame: 2-hour period after the first dose
Other outcomes:
Locations:
city: Storrs
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Boca Raton
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: