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Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media
Phase 2
Waitlist Available
Led By Steven Goldberg, MD
Research Sponsored by Currax Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 72 hour post first dose
Awards & highlights
All Individual Drugs Already Approved
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.
Eligible Conditions
- Ear Infection
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to 72 hour post first dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 72 hour post first dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R)
Secondary study objectives
Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 12 Hours Post First Dose
Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 24 Hours Post First Dose
Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 3 Hour Post First Dose
+7 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Antipyrine and Benzocaine Otic solutionExperimental Treatment2 Interventions
antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping
Group II: Antipyrine Otic SolutionActive Control2 Interventions
Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping
Group III: Benzocaine Otic SolutionActive Control2 Interventions
benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping
Group IV: PlaceboPlacebo Group1 Intervention
Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Benzocaine
FDA approved
Placebo Otic solution
2013
Completed Phase 2
~120
Find a Location
Who is running the clinical trial?
Currax PharmaceuticalsLead Sponsor
6 Previous Clinical Trials
76,841 Total Patients Enrolled
Steven Goldberg, MDPrincipal InvestigatorVisions Clinical Research
James Peterson, MDPrincipal InvestigatorFoothill Family Clinic
John Ansely, MDPrincipal InvestigatorCarolina Ear, Nose and Throat Clinic
Amy Agua, MDPrincipal InvestigatorVisions Clinical Research Boyton Beach
Bryan Harvey, MDPrincipal InvestigatorChildrens Investigational Research Program
Gerald Shockey, MDPrincipal InvestigatorDesert Clinical Research
Shane Christensen, MDPrincipal InvestigatorFoothill Family Clinic South
1 Previous Clinical Trials
344 Total Patients Enrolled
Stephanie Plunkett, MDPrincipal InvestigatorFirst Med East
Katie Julien, MDPrincipal InvestigatorJordan River Family Medcine