Pain Study to Assess Local Anesthetic Efficacy and Safety of CTY-5339 on Gingival Mucosal Tissue in Normal Volunteers
Condition: No Disease State or Condition
Intervention: One spray CTY-5339-A; One spray CTY-5339-CB; One spray CTY-5339-P
Intervention description: Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredients: 14.0% Benzocaine (USP = 28 mg) and 2.0% Tetracaine Hydrochloride (USP = 4 mg). Administered in a single anesthetic spray.; Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredient: 14.0% Benzocaine (USP = 28 mg). Administered in a single anesthetic spray.; Placebo. Metered spray bottle with ≈200 uL total spray volume. Contains no active ingredient (vehicle control).
Intervention MeSH terms: Anesthetics; Tetracaine; Benzocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: local anesthesia; pain tolerance; experimental pain

Summary:

      The purpose of this study is to determine if the topical application to gingival tissue of
      the combination of benzocaine and tetracaine has a longer duration of local anesthetic
      activity than benzocaine alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects between 18-75 years of age with a Body Mass Index (BMI) ≤32;

          -  Subjects are category I or II on the American Society of Anesthesiologists physical
             status classification system (ASA category I or II) and are in normal physical health
             as judged by physical and laboratory examinations;

          -  Subjects have normal appearance of the oral mucosal tissues;

          -  At screening and at Baseline during Stage 1 and Sessions 1 and 2, of Stage 2 subjects
             with Pin-Prick-Test (PPT) scores of at least "3" (on a 10 point numerical rating scale
             [NRS]) on the 2 readings, 1 of which must be a score of at least "4";

          -  Subjects have mean quantitative sensory test of heat (QST-Heat) pain sensation
             temperature assessments on the gingival mucosa of 46.5 °C or less based on the average
             of the 2 readings at screening and at the Baseline Study Sessions for Stages 1 and 2;

          -  Subjects must agree to refrain from ingesting any systemic or topical analgesic
             medication for 3 days or 5 half-lives of the drug prior to and during the study period
             and alcohol for 1 day prior to and during the study period;

          -  Subjects must agree to refrain from using mouth rinses, cough drops or throat lozenges
             on the day of each test session;

          -  Female subjects must be physically incapable of childbearing potential (postmenopausal
             for more than 1 year or surgically sterile) or practicing an acceptable method of
             contraception (hormonal, barrier with spermicide, intrauterine device, vasectomized or
             same sex partner, or abstinence). Subjects using hormonal birth control must have been
             on a stable dose of treatment for at least 30 days and received at least 1 cycle of
             treatment prior to randomization. At Screening and at Baseline of both sessions, all
             females of childbearing potential must have a negative urine pregnancy test and not be
             breastfeeding;

          -  Negative urine drug screen for drugs of abuse at Screening and at Baseline for each
             Study Session. A positive drug screen result may be permitted if the subject has been
             on a stable dose of an allowed medication for >30 days;

          -  Subjects must be capable of reading, comprehending, and signing the informed consent
             form.

        Exclusion Criteria:

          -  Subjects with a history of any significant hepatic, renal, endocrine, cardiac,
             neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic
             disorders, including glaucoma, diabetes, emphysema, and chronic bronchitis;

          -  Subjects with a history of any type of cancer other than skin related cancers;

          -  Subjects with conditions that affect the absorption, metabolism, or passage of drugs
             out of the body, (e.g., sprue, celiac disease, Crohn's disease, colitis, or liver,
             kidney, or thyroid conditions);

          -  Subjects with any history of alcohol or substance abuse (including a positive drug
             screen test);

          -  Subjects that currently have or have a history of uncontrolled hypertension;

          -  Subjects with a known hypersensitivity to any local anesthetic drug;

          -  Subjects with a hematocrit level significantly below the normal range on the screening
             laboratory examination (as judged by the PI);

          -  Subjects with any clinically significant abnormal lab result (as judged by the PI);

          -  Subjects with any condition or history felt by the Investigator to place the subject
             at increased risk;

          -  Subjects who have smoked or chewed tobacco-containing substances within 6 months prior
             to the start of the study;

          -  Subjects judged by the Investigator to be unable or unwilling to comply with the
             requirements of the protocol;

          -  Subjects who have used an investigational drug within 30 days prior to entering the
             study;

          -  Subjects who have donated blood within 3 months prior to the start of the study;

          -  Subjects who have previously participated in the trial;

          -  Subjects who are members of the study site staff directly involved with the study or a
             relative of the Sponsor or other personnel involved with the study.