Status:
TERMINATED
FST-201 In The Treatment of Acute Fungal Otitis Externa
Lead Sponsor:
Shire
Conditions:
Acute Fungal Otitis Externa
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 Applicatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 31 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2010
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00945646
Start Date
July 31 2009
End Date
July 31 2010
Last Update
May 27 2021
Active Locations (6)
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1
ENT Associates of South Florida
Boynton Beach, Florida, United States, 33426
2
Sarasota, Florida, United States, 34239
3
Austin Ear, Nose, and Throat Clinic
Austin, Texas, United States, 78705
4
San Antonio Ear, Nose, and Throat Research
San Antonio, Texas, United States, 78215