At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 110 enrolled
Drug / intervention
Tetracaine HCl 3% and Oxymetazoline HCl 0.05% +2 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 III, Multi-Center, Randomized, Double-Blind, Parallel-Groups Clinical Trial Comparing the Efficacy and Safety of Intranasally Administered Kovacaine Mist to Tetracaine Alone and to Placebo for Anesthetizing Maxillary Teeth in Adults
In Brief
A Phase 3 clinical trial evaluating Tetracaine HCl 3% and Oxymetazoline HCl 0.05%, Tetracaine HCl 3%, and 1 other intervention for Anesthesia. Completed, enrolled 110 participants across 3 sites.
Detailed Summary
The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, 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
Enrollment StartOct 2012
First PostedOct 2012
Primary CompletionFeb 2013
TodayJul 2026
First PostedOct 19, 2012
Enrollment StartOct 1, 2012
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 13.7 years ago
Interventions
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%drug
3 unilateral intranasal sprays per dose
Tetracaine HCl 3%drug
3 unilateral intranasal sprays per dose
Placebodrug
3 unilateral intranasal sprays per dose