FST-201 In The Treatment of Acute Fungal Otitis Externa
Stopped early · Phase 3
Conditions studied: Acute Fungal Otitis Externa
In brief
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.
Key facts
- Study ID
- NCT00945646
- Run by
- Shire
- People needed
- 6
- Starts
- 2009-07-31
- Expected to finish
- 2010-07-31
- Last updated by the study team
- 2021-05-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- ENT Associates of South Florida — Boynton Beach, Florida, United States
- Study site — Sarasota, Florida, United States
- Austin Ear, Nose, and Throat Clinic — Austin, Texas, United States
- San Antonio Ear, Nose, and Throat Research — San Antonio, Texas, United States
- San Antonio Ear, Nose, and Throat Research — San Antonio, Texas, United States
- Ear Institute of Texas — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.