Pain Study to Assess Local Anesthetic Efficacy and Safety of CTY-5339 on Gingival Mucosal Tissue in Normal Volunteers

PHASE2CompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

June 15, 2017

Primary Completion Date

February 20, 2018

Study Completion Date

February 20, 2018

Conditions
No Disease State or Condition
Interventions
COMBINATION_PRODUCT

One spray CTY-5339-A

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.

DEVICE

One spray CTY-5339-CB

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.

DEVICE

One spray CTY-5339-P

Placebo. Metered spray bottle with ≈200 uL total spray volume. Contains no active ingredient (vehicle control).

Trial Locations (1)

19104

University of Pennsylvania, School of Dental Medicine, Philadelphia

Sponsors
All Listed Sponsors
lead

Cetylite Industries

INDUSTRY