FST-201 In The Treatment of Acute Otitis Externa

• Status: Terminated
• Trial end date: 2010-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: BB 1101; Ciprofloxacin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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.