FST-201 In The Treatment of Acute Fungal 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 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.

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

Details

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

Criteria

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