At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 150 enrolled
Drug / intervention
Tetracaine HCl 3% and Oxymetazoline HCl 0.05% +1 moredrug
Likely dose
Not stated in 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.
A Phase 3, Multi-Center, Randomized, Double-Blind, Parallel-Groups Clinical Trial Comparing the Efficacy and Safety of Intranasally Administered Kovacaine Mist to Placebo for Anesthetizing Maxillary Teeth in Adults
In Brief
A Phase 3 clinical trial evaluating Tetracaine HCl 3% and Oxymetazoline HCl 0.05% and Placebo for Anesthesia. Completed, enrolled 150 participants across 3 sites.
Detailed Summary
The purpose of this study is to compare the efficacy of Kovacaine Mist, and Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnesthesia
CountriesUnited States
CollaboratorsTriligent International, Rho, Inc.
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 2012
Enrollment StartFeb 2013
Primary CompletionMay 2013
TodayJul 2026
First PostedDec 10, 2012
Enrollment StartFeb 1, 2013
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 13.6 years ago
Interventions
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%drug
The study drug is regional anesthetic delivered intranasally on the same side as the operative tooth
Placebodrug
The placebo spray was identical in appearance to and was administered in the same volume and manner as the active ingredient.