A Phase III Study of an Otic Formulation in Acute Otitis Externa
NCT ID: NCT00750633
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
990 participants
INTERVENTIONAL
2008-06-30
2009-01-31
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
TRIPLE
Study Groups
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Moxidex
Moxidex otic solution
Moxidex otic solution
4 drops in 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 with effusion in children
Moxifloxacin
Moxifloxacin otic solution
Moxifloxacin otic solution
4 drops in 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 with effusion in children
Dexamethasone
Dexamethasone phosphate otic solution
Dexamethasone phosphate otic solution
4 drops in 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 with effusion in children
Interventions
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Moxidex otic solution
4 drops in the infected ear(s) twice daily (morning and evening) for 7 days
Moxifloxacin otic solution
4 drops in the infected ear(s) twice daily (morning and evening) for 7 days
Dexamethasone phosphate otic solution
4 drops in 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 with effusion in children
Eligibility Criteria
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Inclusion Criteria
* A minimum combined score of ≥4 in at least 1 affected ear at the Day 1 exam for tenderness, erythema, and edema
Exclusion Criteria
* Presence of a tympanostomy tube or perforated tympanic membrane in the treated ear(s). Patients with a history of tympanic membrane perforation should not be enrolled unless the absence of a current perforation can be confirmed at Visit 1 prior to enrollment
* Clinically diagnosed chronic suppurative otitis media, acute otitis media, acute otorrhea in patients with tympanostomy tubes, or malignant otitis externa
* Known or suspected ear infection of fungal or mycobacterial origin
* Prior otologic surgery within 6 months of study entry
* Seborrheic dermatitis or other skin conditions of the external auditory canal
* Current or prior history of an immunosuppressive disorder (e.g., HIV positive) or current immunosuppressive therapy (e.g., cancer chemotherapy) or known acute or chronic renal disorders or active hepatitis
* Diabetic patients (controlled or uncontrolled) based upon assessment by Investigator
* Any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study \[e.g., cleft palate (including repairs), Downs Syndrome, and cranial facial reconstruction\]
* Any current known or suspected infection (other than AOE) requiring systemic antimicrobial therapy
* Use of prohibited medications or inadequate washout of any medication listed in protocol
* Concomitant use of topical or oral analgesics (i.e., NSAIDs and aspirin products) which may have anti inflammatory effects. Patients on low dose aspirin therapy (81 mg per day) at the time of enrollment may be enrolled and continue the low dose aspirin during the study. Use of acetaminophen ("Tylenol") is permitted during the trial
6 Months
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-07-13
Identifier Type: -
Identifier Source: org_study_id