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FST-201 In The Treatment of Acute Fungal Otitis Externa

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 : May 27, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda ( Shire )

Study Description
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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 Application in support of FST-201 for the indication of acute fungal otitis externa.

Condition or disease Intervention/treatment Phase
Acute Fungal Otitis Externa Drug: FST-201 (dexamethasone 0.1%) Otic Suspension Drug: Vehicle Phase 3

Study Design
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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
Actual Study Start Date : July 31, 2009
Actual Primary Completion Date : July 31, 2010
Actual Study Completion Date : July 31, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Molds

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Microbiological resolution defined as absence of pre-treatment pathogenic fungal species. [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Shire
Investigators
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Study Director: Study Director Takeda
More Information
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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: May 27, 2021
Last Verified: May 2021
Additional relevant MeSH terms:
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Otomycosis
Otitis
Otitis Externa
Ear Diseases
Otorhinolaryngologic Diseases
Mycoses
Bacterial Infections and Mycoses
Infections
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