Benzocaine Gel Toothache Dose-Response Study
Condition: Toothache
MeSH terms: Toothache
Intervention: Placebo gel; benzocaine; benzocaine
Intervention description: single dose (less than 1g) of a matching placebo gel; single dose (less than 1g) of 10% benzocaine gel formulation; single dose (less than 1g) of 20% benzocaine gel formulation
Intervention MeSH terms: Benzocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 577.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy and safety of benzocaine gel products for the relief of toothache
      and to assess the subject's compliance with proposed label directions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females at least 12 years of age.

          -  Presence of spontaneous toothache pain in only one permanent tooth. Toothache pain is
             due only to an open tooth cavity and only as a result of dental caries, loss of a
             restoration or tooth fracture.

          -  To qualify for the study, the subject must have a rating of at least moderate pain on
             the Dental Pain Scale (DPS) and a score of at least 50 mm on the Visual Analog Scale.
             To be included in the moderate pain stratum, the subjects must have a rating of
             moderate pain in the DPS and to be included in the severe pain stratum the subjects
             must have a rating of severe pain in the DPS.

          -  Females who are neither pregnant, as verified by a urine-based pregnancy test, nor
             breast-feeding.

          -  Female subjects of childbearing potential and those who are post-menopausal for less
             than 2 years must be using a medically approved method of contraception (i.e., oral,
             transdermal or implanted contraceptive devices, intrauterine device, diaphragm,
             condom, abstinence, or surgical sterility).

          -  Subjects must be reliable, cooperative and of adequate intelligence to read and
             understand the rating scales and other study instructions.

          -  Subjects must be able to read, comprehend, and sign the consent form. Minors will
             provide assent to study participation if age appropriate. Parent/legal guardian must
             be able to read, comprehend, and sign the informed consent form.

        Exclusion Criteria:

          -  Presence of spontaneous toothache pain in a primary tooth. Presence of spontaneous
             toothache pain in more than one tooth. Presence of an open tooth cavity in a tooth
             adjacent to the painful tooth with the open tooth cavity.

          -  Presence of concomitant oral pain due to any other condition such as: soft-tissue
             lesions (e.g., aphthous or traumatic ulcer, herpes labialis, acute necrotizing
             ulcerative gingivitis); or multiple hard-tissue (e.g., carious) lesions; pain due to
             other surgical procedures, injuries or dental surface sensitivity.

          -  Presence of a periodontal abscess as diagnosed from an X-ray or clinical examination
             of the painful tooth.

          -  Presence of glucose-6-phosphate dehydrogenase (G6PD) deficiency.

          -  History of acute or chronic hemolytic anemia.

          -  History of sensitivity or allergy to benzocaine or other local anesthetic agents.

          -  Use of any short-acting oral or topical analgesic/ anesthetic product within 2 hours
             of enrollment or any long-acting Rx or OTC analgesic product within 4 hours of
             enrollment.

          -  Use of an investigational drug or participation in an investigational study within the
             past 30 days.

          -  Previous participation in this study.

          -  Member or a relative of the study site staff or sponsor directly involved in the
             study.