At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 150 enrolled
Drug / intervention
OraVerse +1 moredrug
Likely dose
OraVerse 1.8mLfrom 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 4, Multicenter, Randomized, Double-Blinded, Controlled Study of OraVerse® for Safety and Efficacy in Pediatric Dental Patients Undergoing Mandibular and Maxillary Procedures
In Brief
A Phase 4 clinical trial evaluating OraVerse and Sham injection for Dental Anesthesia and 2 related conditions. Completed, enrolled 150 participants across 7 sites.
Detailed Summary
The purpose of this study is to determine whether OraVerse is safe and effective for the reversal of dental anesthesia in children 2 to 5 years of age weighing at least 10 kg.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Anesthesia, Anesthesia, Local, Anesthesia, Reversal
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 2011
Enrollment StartFeb 2012
Primary CompletionAug 2014
TodayJul 2026
First PostedNov 18, 2011
Enrollment StartFeb 1, 2012
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 14.6 years ago
Interventions
OraVersedrug
1.8mL dental cartridge delivered in doses of either 1/4, 1/2 or 1 cartridge depending on subject weight
Sham injectionother
No drug administered, simulation of injection used in same manner as drug