Placebo-Controlled Onset-of-Action Study of Flurbiprofen Utilizing the Double-Stopwatch Method
Condition: Acute Pharyngitis; Sore Throat
MeSH terms: Pharyngitis
Intervention: flurbiprofen; placebo
Intervention description: A single flurbiprofen 8.75 mg lozenge which also contains 1 mg of menthol in its vehicle base for flavour and taste purposes (blinding). Lozenge is sucked until dissolved, and not chewed, bit or swallowed.; A single placebo lozenge which also contains 1 mg of menthol in its vehicle base for flavour and taste purposes (blinding). Lozenge is sucked until dissolved, and not chewed, bit or swallowed.
Intervention MeSH terms: Flurbiprofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pharyngitis; Sore Throat; acute upper respiratory tract infection (URTI)

Summary:

      The study's purpose is to demonstrate the onset of action, i.e., time to meaningful pain
      relief in patients with pharyngitis, of flurbiprofen 8.75 mg lozenge using the
      Double-Stopwatch Method (DSW).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary diagnosis: pharyngitis confirmed by a Tonsillo-Pharyngitis Assessment ≥ 5

          -  Complaint of sore throat with an onset ≤ 4 days prior to randomization

          -  Have at least one symptom of upper respiratory tract infection (URTI) on the URTI
             Questionnaire (e.g., sore throat, runny nose, cough, fever)

          -  Have moderate or severe sore throat pain on the Throat Pain Scale

          -  Have a baseline Sore Throat Scale (STS) ≥ 6

          -  If the patient is a female of childbearing potential, she has been using effective
             contraception since the last date of menses and is not breast-feeding or lactating.
             She is also willing to take adequate contraceptive precautions through 24 hours after
             the completion of the study.

          -  If the patient is a female of childbearing potential, the patient must have a negative
             urine pregnancy test (UPT) result (indicating "not pregnant") obtained on the day of
             scheduled randomization, prior to the designated time of randomization

          -  The patient is willing to remain at the study centre for 3 hours after receiving the
             dose of study medication

          -  During the 3-hour evaluation of the study medication lozenge at the site, the patient
             is willing to take "nothing by mouth" (e.g., no smoking, food, candy, lozenges,
             chewing gum, liquids).

        Exclusion Criteria:

          -  Known allergy and/or hypersensitivity to aspirin or other nonsteroidal
             anti-inflammatory drugs (NSAIDs), or any other inactive ingredients such as honey,
             lemon flavor, menthol, or sucrose.

          -  History of an upper gastrointestinal ulcer within the past 60 days, current clinically
             significant upper gastrointestinal complaints, or current regular use (≥ 3 times in
             the previous week) of any medication for upper gastrointestinal symptoms, including
             antacids, H2 blockers, proton pump inhibitors or sucralfate

          -  History of any hepatic disease or renal dysfunction

          -  Other severe acute or chronic medical condition that may increase the risk associated
             with study participation or may interfere with the interpretation of study results
             and, in the judgment of the Investigator, would make the patient inappropriate for
             entry into this study.

          -  History of chronic analgesic use (≥ 3 times per week over the prior 4 weeks)

          -  Use of an antibiotic for an acute disease within the previous 24 hours before
             randomization. (Chronic antibiotic use, such as for acne, is acceptable.) Use of any
             quinolone antibiotic such as ciprofloxacin or nalidixic acid within the past week or
             concurrently is specifically prohibited.

          -  Use of mifepristone in the 12 days prior to the screening visit

          -  Use of inhaled therapy (e.g., inhaled steroids or β-agonists, such as Ventolin) on an
             acute basis for disease exacerbation in the week prior to the screening visit

          -  Use of any immediate release analgesic within 4 hours preceding administration of the
             study medication.

          -  Use of any sustained release analgesic within 12 hours preceding administration of the
             study medication.

          -  Use of any "cold medication" (i.e. decongestants, antihistamines, expectorants,
             antitussives) within 4 hours preceding administration of the dose of study medication.

          -  Use of any throat lozenge, throat spray, cough drop, or menthol-containing product
             within 2 hours preceding administration of the study medication

          -  Consumption of any caffeine-containing beverage (e.g., coffee, tea, hot chocolate,
             caffeinated soft drinks) within 5 minutes preceding administration of the study
             medication.

          -  Any evidence of mouth-breathing (which could worsen sore throat pain).

          -  Coughing that causes throat discomfort or any active physical disease (such as
             bronchopneumonia) which could compromise respiratory function and worsen a sore throat

          -  Unable in the opinion of the Investigator to comply fully with the study requirements