At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 48 enrolled
Drug / intervention
400uL of Kovacaine Mist +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 2, Single-Center, Open-Label, Randomized, Parallel-Groups, Dose-Ranging Study to Assess the Efficacy and Safety of Intranasally Administered Kovacaine Mist for Anesthetizing Maxillary Teeth in Pediatric Subjects
In Brief
A Phase 2 clinical trial evaluating 400uL of Kovacaine Mist, 200uL of Kovacaine Mist, and 1 other intervention for Anesthesia. Completed, enrolled 48 participants across 1 site.
Detailed Summary
The purpose of this study is to assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnesthesia
CountriesUnited States
CollaboratorsTriligent International, Rho, Inc.
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2012
Primary CompletionOct 2012
First PostedOct 2012
TodayJul 2026
First PostedOct 5, 2012
Enrollment StartOct 1, 2012
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 13.7 years ago
Interventions
400uL of Kovacaine Mistdrug
2 unilateral intranasal sprays of 200uL each.
200uL of Kovacaine Mistdrug
2 unilateral intranasal sprays of 100uL each.
120uL of Kovacaine Mistdrug
2 unilateral intranasal sprays of 60uL each.