CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
3% tetracaine HCL with 0.05% oxymetazoline HCL +1 moredrug
Likely dose
3% tetracaine HCL with 0.05% oxymetazoline HCL 18 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/NCT01302483
NCT01302483Phase 2Completed
CompareCT.gov

A Phase II, Single-Center, Randomized, Double-Blind, Active-Treatment-Controlled, Parallel-Group Study of the Efficacy of Kovacaine Nasal Spray for Anesthetizing Maxillary Teeth in Healthy Dental Patients

St. Renatus, LLC·interventional·Posted Feb 24, 2011·Updated Jun 17, 2015

In Brief

A Phase 2 clinical trial evaluating 3% tetracaine HCL with 0.05% oxymetazoline HCL and Lidocaine Injection for Dental Anesthesia Efficacy. Completed, enrolled 45 participants across 1 site.

Detailed Summary

The purpose of this study was to determine the safety and efficacy of Kovacaine Mist (3% tetracaine HCl with 0.05% oxymetazoline HCl) for anesthesia of the maxillary teeth for dental procedures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Anesthesia Efficacy
CountriesUnited States
CollaboratorsGround Zero Pharmaceuticals, Rho, Inc.

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 24, 2011
Enrollment StartDec 1, 2008
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 15.4 years ago

Interventions

3% tetracaine HCL with 0.05% oxymetazoline HCLdrug

1 sham injection along with 3 sprays of Kovacaine Nasal Spray in each nostril; a 4-minute interval between every set of sprays. The total dose of 3% tetracaine HCL with 0.05% oxymetazoline HCL was 18 mg/0.3 mg.

Lidocaine Injectiondrug

Each subject received both an injection along with 3 sprays of isotonic saline sham in each nostril; a 4-minute interval between every set of sprays.