FST-201 In The Treatment of Acute Fungal Otitis Externa
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00945646 |
Recruitment Status :
Terminated
First Posted : July 24, 2009
Last Update Posted : September 30, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Fungal Otitis Externa | Drug: FST-201 (dexamethasone 0.1%) Otic Suspension Drug: Vehicle | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | July 2009 |
Actual Primary Completion Date : | July 2010 |
Actual Study Completion Date : | July 2010 |
Arm | Intervention/treatment |
---|---|
Experimental: FST-201 (dexamethasone 0.1%) Otic Suspension |
Drug: FST-201 (dexamethasone 0.1%) Otic Suspension
Instill four drops times two times a day. |
Placebo Comparator: vehicle |
Drug: Vehicle
Instill four times two times a day |
- Overall clinical cure as defined by absence of the signs and symptoms of AFOE including ear inflammation, edema, tenderness, pruritis and otic discharge. [ Time Frame: 1 year ]
- Microbiological resolution defined as absence of pre-treatment pathogenic fungal species. [ Time Frame: 1 year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945646
United States, Florida | |
ENT Associates of South Florida | |
Boynton Beach, Florida, United States, 33426 | |
Sarasota,, Florida, United States, 34239 | |
United States, Texas | |
Austin Ear, Nose, and Throat Clinic | |
Austin, Texas, United States, 78705 | |
San Antonio Ear, Nose, and Throat Research | |
San Antonio, Texas, United States, 78215 | |
San Antonio Ear, Nose, and Throat Research | |
San Antonio, Texas, United States, 78229 | |
Ear Institute of Texas | |
San Antonio, Texas, United States, 78258 |
Responsible Party: | Shire |
ClinicalTrials.gov Identifier: | NCT00945646 |
Other Study ID Numbers: |
FST201-AFOE-02 |
First Posted: | July 24, 2009 Key Record Dates |
Last Update Posted: | September 30, 2015 |
Last Verified: | September 2012 |
Otomycosis Otitis Otitis Externa Ear Diseases Otorhinolaryngologic Diseases Mycoses Dexamethasone Anti-Inflammatory Agents Antiemetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |