Acute Fungal Otitis Externa Clinical Trial
Official title:
A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled Clinical Study Evaluating the Efficacy Of FST-201 (Dexamethasone 0.1%) Otic Suspension in Subjects With Acute Fungal Otitis Externa
| Verified date | May 2021 |
| Source | Takeda |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 6 |
| Est. completion date | July 31, 2010 |
| Est. primary completion date | July 31, 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Austin Ear, Nose, and Throat Clinic | Austin | Texas |
| United States | ENT Associates of South Florida | Boynton Beach | Florida |
| United States | Ear Institute of Texas | San Antonio | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Shire |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall clinical cure as defined by absence of the signs and symptoms of AFOE including ear inflammation, edema, tenderness, pruritis and otic discharge. | 1 year | ||
| Secondary | Microbiological resolution defined as absence of pre-treatment pathogenic fungal species. | 1 year |