Phase 2
N=112
Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media
Acute Otitis Media
Bottom Line
View on ClinicalTrials.gov: NCT02037893 ↗Enrolled (actual)
112
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) — -4.3; -5.0; -4.6; -4.9 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Antipyrine and Benzocaine otic solution (Drug); Antipyrine Otic Solution (Drug); Benzocaine Otic Solution (Drug); Placebo Otic solution (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Currax Pharmaceuticals
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) |
-4.3; -5.0; -4.6; -4.9 | — |
| SECONDARY Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R)15 Min Post First Dose |
-3.6; -3.6; -3.4; -3.8 | — |
| SECONDARY Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 30 Min Post First Dose |
-3.9; -4.3; -4.4; -4.8 | — |
| SECONDARY Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 3 Hour Post First Dose |
-3.4; -3.9; -3.8; -3.5 | — |
| SECONDARY Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 6 Hours Post First Dose |
-3.4; -4.0; -3.9; -3.8 | — |
| SECONDARY Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 12 Hours Post First Dose |
-3.9; -4.3; -4.1; -4.0 | — |
| SECONDARY Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 24 Hours Post First Dose |
-5.5; -4.4; -4.2; -4.6 | — |
| SECONDARY Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 36 Hours Post First Dose |
-5.5; -4.6; -4.4; -5.5 | — |
| SECONDARY Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 48 Hours Post First Dose |
-5.4; -5.3; -4.7; -5.9 | — |
| SECONDARY Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 60 Hours Post First Dose |
-5.4; -5.4; -5.4; -6.2 | — |
| SECONDARY Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 72 Hours Post First Dose |
-5.9; -5.9; -5.4; -6.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Clinical Diagnosis of Acute Otitis Media
- Moderate to severe pain
- Normally active and in good health as determined by the PI
- Parent or legal guardian consent
- Caregiver available to complete diaries during study
Exclusion Criteria
- History of or current Perforated tympanic membrane
- Tympanostomy tubes
- Acute or chronic otitis externa
- seborrheic dermatitis
- Received any otic topical or systemic antibiotic within 14 days of enrollment
- Receiving medication on a chronic basis for pain
- Known hypersensitivity to investigational product.
- clinical significant mental illness as determined by the PI
- Exposed to another investigational agent within 30 days before study entry. Any condition the PI believed will interfere with the ability to comply with all study procedures
- History of glucose 6-phosphate dehydrogenase deficiency
- History or currently anemic
- Congenital methemoglobinemia
- Recent history of acute gastroenteritis within 14 days of enrollment
Data sourced from ClinicalTrials.gov (NCT02037893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.