A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea (NCT00578773) | Clinical Trial Compass
CompletedPhase 2
A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea
303 participantsStarted 2007-11
Plain-language summary
The purpose of this study is to determine if an otic formulation is safe and effective in treating peri-operative tube otorrhea.
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
* Diagnosed with recurrent acute otitis media or chronic otitis media with effusion
* Must be first set of ear tubes.
* Patient may not have had any other previous otologic-related surgery.
* Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube
* Patient may not have existing perforation of the eardrum.
* Patient must not require another surgical procedure other than myringotomy and tube insertion.
* 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