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Completed

NCT Number: NCT00647829

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

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.

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Key information

Conditions

Pharyngitis Infections Otorhinolaryngologic Diseases Pharyngeal Diseases Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Storrs, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

valdecoxib

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing

    Time frame: 2-hour period after the first dose

Secondary outcomes

  1. Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing

    Time frame: 4, 6, 8, 10, 12, and 24 hours after first dose

  2. Peak Sore Throat Pain Intensity Difference (PPID) on swallowing

    Time frame: 24-hour period after the first dose

  3. Throat Soreness Difference (TSD) on swallowing

    Time frame: each post dose time point

  4. Sum of Throat Soreness Difference (STSD) on swallowing

    Time frame: 2, 4, 6, 8, 10, 12, and 24 hours after first dose

  5. Peak Throat Soreness Difference (PTSD) on swallowing

    Time frame: 24-hour period after the first dose

  6. Sum of Sore Throat Relief Rating (SSTRR) on swallowing

    Time frame: 2, 4, 6, 8, 10, 12, and 24 hours after first dose

  7. Peak Sore Throat Relief Rating (PSTRR) on swallowing

    Time frame: 24-hour period after the first dose

  8. Time to onset of analgesia

    Time frame: 2-hour period after the first dose

  9. Time to rescue medication

    Time frame: 24-hour period after the first dose

  10. Patient's global evaluation of study medication

    Time frame: 24-hour period after the first dose

  11. Percent of patients taking rescue medications

    Time frame: 24-hour period after the first dose

  12. Sore Throat Relief Rating (STRR) on swallowing

    Time frame: post dose time point

  13. Patient's satisfaction with treatment

    Time frame: 24-hour period after the first dose

  14. Sore Throat Pain Intensity Difference (PID, VAS) on swallowing

    Time frame: each post dose time point

  15. Time to perceptible pain relief

    Time frame: 2-hour period after the first dose

  16. Time to meaningful pain relief

    Time frame: 2-hour period after the first dose

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2003
First posted
Apr 1, 2008
Registry last updated
Apr 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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