FST-201 In The Treatment of Acute Otitis Externa

Shire

Status and phase

Terminated

Phase 3

Conditions

Acute Otitis Externa

Treatments

Drug: FST-201 (dexamethasone 0.1%) Otic Suspension

Drug: ciprofloxacin 0.3%, dexamethasone 0.1%

Study type

Interventional

Funder types

Industry

Identifiers

NCT00945802

FST201-AOE-02

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.