A Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes
NCT ID: NCT00578474
Last Updated: 2012-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
911 participants
INTERVENTIONAL
2005-12-31
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Moxidex
Moxidex otic solution
Moxidex otic solution
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
Tympanostomy tubes
Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
FLOXIN
Ofloxacin otic solution
Ofloxacin otic solution
5 drops into the infected ear(s) twice daily (morning and evening) for 10 days
Tympanostomy tubes
Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
Interventions
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Moxidex otic solution
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
Ofloxacin otic solution
5 drops into the infected ear(s) twice daily (morning and evening) for 10 days
Tympanostomy tubes
Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
6 Months
12 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Contact Alcon Call Center
Role: STUDY_DIRECTOR
1-888-451-3937
Countries
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Other Identifiers
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C-05-35
Identifier Type: -
Identifier Source: org_study_id