FST-201 in the Treatment of Acute Otitis Externa

• Status: Completed
• Trial end date: 2010-06-30
• Target enrollment: 0
• Participant gender: Male

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 study will be conducted at one site, the Lyndon B. Johnson (LBJ) Tropical Medical Center, Department of Otolaryngology, in Pago Pago, American Samoa.

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

Details

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

Criteria

Inclusion Criteria:

Study participants must:

• 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

Exclusion Criteria:

Study participants 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 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

• Be pregnant, nursing or planning a pregnancy