NCT00945802TerminatedPhase 3
A Multi-Center, Randomized, Double-Masked Clinical Study Evaluating the Efficacy Of FST-201 (Dexamethasone 0.1%) Otic Suspension (Foresight Biotherapeutics, Inc.) Vs. Ciprodex (Ciprofloxacin 0.3%, Dexamethasone 0.1%) Otic Suspension (Alcon Laboratories, Inc.) in Subjects With Acute Otitis Externa
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Shire
- Enrollment
- 5
- Locations
- 4
- Primary Endpoint
- Overall clinical cure as defined by absence of the signs and symptoms of AOE including ear inflammation, edema, tenderness and otic discharge.
Study Overview
Brief Summary
The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in the treatment of acute otitis externa. This trial is designed to enable filing of a New Drug Application in support of FST-201 for the indication of acute otitis externa.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have a clinical diagnosis of AOE in one or both ears, defined as a clinical score of at least 1 for edema (0-3 scale), 2 for overall inflammation (0-3 scale) and 1 for tenderness (absent=0, present=1).
- •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
- •All subjects must not:
- •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.
Arms & Interventions
FST-201 (dexamethasone 0.1%) Otic Suspension
Experimental
Intervention: FST-201 (dexamethasone 0.1%) Otic Suspension (Drug)
ciprofloxacin 0.3%, dexamethasone 0.1%
Active Comparator
Intervention: ciprofloxacin 0.3%, dexamethasone 0.1% (Drug)
Outcomes
Primary Outcomes
Overall clinical cure as defined by absence of the signs and symptoms of AOE including ear inflammation, edema, tenderness and otic discharge.
Time Frame: 1 year
Secondary Outcomes
- Microbiological resolution defined as elimination of pre-treatment pathogenic bacteria.(1 year)
Investigators
Study Sites (4)
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