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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TERMINATED
PHASE3
5 participants
INTERVENTIONAL
2009-07-31
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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FST-201 (dexamethasone 0.1%) Otic Suspension
FST-201 (dexamethasone 0.1%) Otic Suspension
Instill four drops two times a day
ciprofloxacin 0.3%, dexamethasone 0.1%
ciprofloxacin 0.3%, dexamethasone 0.1%
Instill four drops two times a day
Interventions
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FST-201 (dexamethasone 0.1%) Otic Suspension
Instill four drops two times a day
ciprofloxacin 0.3%, dexamethasone 0.1%
Instill four drops two times a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be at least 18 years of age at Visit 1 (Day 1, Screening/Baseline) of either sex and any race.
* Provide written informed consent or parental assent.
* Be willing and able to follow all instructions and attend all study visits
Exclusion Criteria
* Have known sensitivity to any component of the study medications
* Have a current infection requiring systemic antimicrobial treatment
* Have used topical or systemic pain meds on the same day as Screening/Baseline Visit 1 and for the duration of the study.
* Take any systemic (within 30 days) or otic corticosteroids (within 1 days) prior to Screening/Baseline Visit 1
* Current use of topical or systemic non-steroidal or other anti-inflammatory drugs.
* Use any topical otic treatment with alcohol, vinegar, hydrogen peroxide or other astringent medication during the course of the study or on the same day as Screening/Baseline Visit 1
* Have taken any antibiotics within 3 days prior to Visit 1
* Have signs and symptoms of AOE for \> 4 weeks at Screening/Baseline Visit 1
* Have a non-intact or perforated tympanic membrane in the enrolled ear
* Have a clinical diagnosis of chronic suppurative otitis media, acute otitis media or acute otorrhea in patients with tympanostomy tubes
* Have a clinical diagnosis of malignant otitis externa
* Have overt fungal AOE
* Have a viral infection of the pinna or tympanic membrane (i.e herpes zoster)
* Have congenital abnormalities of the external auditory canal in the enrolled ear(s)
* Have obstructive bony exostoses in the enrolled ear(s)
* Have mastoid or other suppurative, non-infectious ear disorders (e.g, cholesteatoma)
* Have malignant tumors of the external auditory canal
* Have a history of otologic surgery. Surgery performed more than 1 year prior to Screening/Baseline Visit 1and limited to the tympanic membrane is allowed
* Have seborrheic dermatitis of the external auditory canal
* Have a current or prior history of immunosuppressive disorders
* Have acute or chronic renal insufficiency, hepatitis or diabetes mellitus
* Be pregnant, nursing or planning a pregnancy.
18 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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ENT Associates of South Florida
Boynton Beach, Florida, United States
Sarasota, Florida, United States
Austin Ear, Nose, and Throat Clinic
Austin, Texas, United States
San Antonio Ear, Nose, and Throat Research
San Antonio, Texas, United States
San Antonio Ear, Nose, and Throat Research
San Antonio, Texas, United States
Ear Institute of Texas
San Antonio, Texas, United States
Countries
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Other Identifiers
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FST201-AOE-02
Identifier Type: -
Identifier Source: org_study_id
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