FST-201 In The Treatment of Acute Fungal Otitis Externa

Shire

Status and phase: Terminated; Phase 3

Conditions: Acute Fungal Otitis Externa

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00945646

FST201-AFOE-02

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy of FST-201 compared to vehicle in the treatment of acute fungal otitis externa. This trial is designed to enable filing of a New Drug Application in support of FST-201 for the indication of acute fungal otitis externa.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a clinical diagnosis of AFOE of in one or both ears, based on 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) and/or 1 for pruritis (absent = 0, present = 1)
• Have appearance consistent with fungal debris, i.e. white or black appearance consistent with Aspergillus spp. or Candida spp.
• Be at least 18 years of age at Visit 1 (Day 1, Screening/Baseline) of either sex and any race
• Provide written informed consent
• Be willing and able to follow all instructions and attend all study visits
• If female and of child bearing potential, agree to and submit a urine sample for pregnancy testing at Visit 1 and upon their exit from the study. Post menopausal is defined as having no menses for 12 consecutive months.

Exclusion criteria

• Have known sensitivity to any component of the study medications
• Have a current infection requiring systemic antimicrobial treatment
• Take any systemic (within 30 days) or otic corticosteroids (within 1 day) prior to Visit 1
• Have used topical or systemic anti-inflammatory agents on the same day as Visit 1 and for the duration of the study
• Have used topical or systemic pain medications on the same day as Visit 1 and for the duration of the study
• Have used any topical otic treatment within 1 days prior to Visit 1

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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6 participants in 2 patient groups, including a placebo group

FST-201 (dexamethasone 0.1%) Otic Suspension

Experimental group

Treatment:

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

vehicle

Placebo Comparator group

Treatment:

Drug: Vehicle