CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 75 enrolled
Drug / intervention
One spray CTY-5339-A +2 morecombination
Likely dose
One spray CTY-5339-A 28 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03233737
NCT03233737Phase 2Completed

A Double-blind, Cross-over, Incomplete Factorial Study to Assess the Local Anesthetic Efficacy and Safety of CTY-5339 Anesthetic Spray (CTY-5339A) When Applied to the Gingival Mucosal Tissue in Normal Volunteers

Cetylite Industries·interventional·Posted Jul 31, 2017·Updated Aug 21, 2019

In Brief

A Phase 2 clinical trial evaluating One spray CTY-5339-A, One spray CTY-5339-CB, and 1 other intervention for No Disease State or Condition. Completed, enrolled 75 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJul 31, 2017
Enrollment StartJun 15, 2017
Primary CompletionFeb 20, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.9 years ago

Interventions

One spray CTY-5339-Acombination

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.

One spray CTY-5339-CBdevice

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.

One spray CTY-5339-Pdevice

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