Experimental Pain Study to Assess Local Anesthetic Efficacy and Safety of CTY-5339 Anesthetic Spray in Normal Volunteers
Condition: Anesthesia
Study type: Interventional
Phase: Phase 2

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

Detailed description: 
      In a blinded study, either benzocaine alone of the combination of benzocaine and tetracaine
      will be sprayed onto the cheek mucosal tissue. Onset and duration of local anesthesia will be
      evaluated over a one hour period using pin prick and QST heat stimulation. Subjects will
      receive both treatments in a cross-over design with each session separated by 5-7 days. A
      total of 76 subjects (normal volunteers) will be evaluated.
    

Intervention name(s): One spray CTY-5339-A; One spray CTY-5339-CB; Two sprays CTY-5339-A; One spray CTY-5339-CB in combination with one spray CTY-5339-P (vehicle control: placebo)
Intervention type(s): Combination Product; Drug; Combination Product; Drug
Intervention description(s): 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.; Metered spray bottle with ≈400 uL total spray volume. Contains the active ingredients: 14.0% Benzocaine (USP = 56 mg total) and 2.0% Tetracaine Hydrochloride (USP = 8 mg total). Administered in two anesthetic sprays.; A single spray of CTY-5339-CB in a metered spray bottle with ≈200 uL total spray volume, containing the active ingredient: 14.0% Benzocaine (USP = 28 mg). This was administered in combination with a single spray of CTY-5339-P (acting as vehicle control placebo with no active ingredient) in a metered spray bottle with ≈200 uL total spray volume. This combination was used to maintain double-blind conditions. The vehicle control was sprayed outside the circumscribed area to avoid dilution of active drug.
Other intervention name(s): CTY-5339-A; CTY-5339 Anesthetic Spray; benzocaine; tetracaine; tetracaine HCl; 14.0% benzocaine; 2.0% tetracaine HCl; 2.0% tetracaine; 14.0% benzocaine and 2.0% tetracaine HCl; 14.0% benzocaine and 2.0% tetracaine; benzocaine and tetracaine HCl; benzocaine and tetracaine; CTY-5339-CB; benzocaine; 14.0% benzocaine; CTY-5339-A; CTY-5339 Anesthetic Spray; benzocaine; tetracaine; tetracaine HCl; 14.0% benzocaine; 2.0% tetracaine HCl; 2.0% tetracaine; 14.0% benzocaine and 2.0% tetracaine HCl; 14.0% benzocaine and 2.0% tetracaine; benzocaine and tetracaine HCl; benzocaine and tetracaine; CTY-5339-CB and Placebo; CTY-5339-CB and Vehicle Control; CTY-5339-CB and Control; benzocaine; benzocaine and Placebo; benzocaine and Vehicle Control; benzocaine and Control; 14.0% benzocaine; 14.0% benzocaine and Placebo; 14.0% benzocaine and Vehicle Control; 14.0% benzocaine and Control
Intervention MeSH terms: Anesthetics; Tetracaine; Benzocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention