Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes (NCT00579189) | Clinical Trial Compass
CompletedPhase 3
Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes
776 participantsStarted 2006-01
Plain-language summary
The purpose of this study is to determine if a topical otic formulation is safe and effective in treating middle ear infections in patients with ear tubes.
Who can participate
Age range6 Months – 12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 6 months to 12 years old
* Ear tubes in one or both ears
* Ear drainage visible by the parent / guardian
* Ear drainage less than 21 days
* Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube
* Patient may not have non-tube otorrhea
* Patient may not have had otic surgery other than tube placement in the last year
* Patient may not be a menarchal female
* Diabetic patients are not eligible
* Patient may not have any disease or condition that would negatively affect the conduct of the study
* Patient may not require any other systemic antimicrobial therapy during the study.
* Patient must meet certain medication washouts to be eligible
* Analgesic use (other than acetaminophen) is not allowed
* Patient may not be pre-disposed to neurosensory hearing loss
* Other protocol-defined inclusion criteria may apply
Exclusion Criteria:
* Age
* Other protocol-defined exclusion criteria may apply
What they're measuring
1
Time to cessation of otorrhea as recorded by the parent or guardian via a patient diary