At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 112 enrolled
Drug / intervention
Antipyrine and Benzocaine otic solution +3 moredrug
Likely dose
Antipyrine and Benzocaine otic solution 54 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.
A Four-arm, Randomized, Double-blind, Active and Placebo Controlled Study to Determine the Safety and Efficacy of a Combination Antipyrine and Benzocaine Otic Solution Compared With Antipyrine Otic Solution Alone, Benzocaine Otic Solution Alone and to Placebo Otic Solution to Relieve Pain Symptoms in Children With Acute Otitis Media.
In Brief
A Phase 2 clinical trial evaluating Antipyrine and Benzocaine otic solution, Antipyrine Otic Solution, and 2 other interventions for Acute Otitis Media. Completed, enrolled 112 participants across 10 sites.
Detailed Summary
The primary objective is to compare the effect of treatment with a combination of ear solutions on the reduction of pain symptoms at 1 hour after dosing in children with acute otitis media.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Otitis Media
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartNov 2013
First PostedJan 2014
Primary CompletionSep 2014
TodayJul 2026
First PostedJan 16, 2014
Enrollment StartNov 1, 2013
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 12.5 years ago
Interventions
Antipyrine and Benzocaine otic solutiondrug
antipyrine 54 mg and benzocaine 14 mg
Antipyrine Otic Solutiondrug
Antipyrine 54 mg and glycerine dehydrated to 1.0 mL
Benzocaine Otic Solutiondrug
benzocaine 14 mg and glycerine dehydrated to 1.0 mL
Placebo Otic solutiondrug
Placebo otic solution will be glycerin that is dehydrated