Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media
Completed · Phase 2 · Has a placebo group
Conditions studied: Acute Otitis Media
In brief
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.
Key facts
- Study ID
- NCT02037893
- Run by
- Currax Pharmaceuticals
- People needed
- 112
- Starts
- 2013-11-01
- Expected to finish
- 2014-09-01
- Last updated by the study team
- 2024-08-07
Who can join
Age: 0 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Desert Clinical Research — Mesa, Arizona, United States
- Visions Clinical Research — Tucson, Arizona, United States
- Childrens Investigational Research Program — Bentonville, Arkansas, United States
- Visions Clinical Research — Boynton Beach, Florida, United States
- Kentucky Pediatric and Adult Research — Bardstown, Kentucky, United States
- Carolina Ear, Nose and Throat Clinic — Orangeburg, South Carolina, United States
- Foothill Family Clinic — Salt Lake City, Utah, United States
- FirstMed East — Salt Lake City, Utah, United States
- Foothill Family Clinic South — Salt Lake City, Utah, United States
- Jordan River Family Medicine — South Jordan, Utah, United States
Full record on ClinicalTrials.gov
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