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

NCT ID: NCT00647829

Last Updated: 2008-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2003-12-31

Brief Summary

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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 Description

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Conditions

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Pharyngitis

Keywords

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pharyngitis, sore throat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Arm 1

Group Type ACTIVE_COMPARATOR

valdecoxib

Intervention Type DRUG

valdecoxib 20 mg tablet by mouth twice daily (BID) for 2 doses over a 24-hour period

Arm 2

Group Type ACTIVE_COMPARATOR

valdecoxib

Intervention Type DRUG

valdecoxib 40 mg tablet by mouth once daily (QD) for 2 doses over a 24-hour period

Arm 3

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo tablet by mouth for 2 doses over a 24-hour period

Interventions

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valdecoxib

valdecoxib 20 mg tablet by mouth twice daily (BID) for 2 doses over a 24-hour period

Intervention Type DRUG

valdecoxib

valdecoxib 40 mg tablet by mouth once daily (QD) for 2 doses over a 24-hour period

Intervention Type DRUG

placebo

placebo tablet by mouth for 2 doses over a 24-hour period

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Storrs, Connecticut, United States

Site Status

Pfizer Investigational Site

Boca Raton, Florida, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3471026&StudyName=Double-Blind%2C%20Randomized%20Protocol%20For%20Comparison%20Of%20The%20Efficacy%2C%20And%20Safety%20Of%20Valdecoxib%2020%20Mg%20Twice%20Daily%2C%20Valdecoxib%2040%20Mg%20Dai

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Other Identifiers

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A3471026

Identifier Type: -

Identifier Source: org_study_id