Back to resultsFST-201 In The Treatment of Acute Fungal Otitis Externa
Primary Purpose
Acute Fungal Otitis Externa
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
FST-201 (dexamethasone 0.1%) Otic Suspension
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Acute Fungal Otitis Externa
Eligibility 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
Sites / Locations
- ENT Associates of South Florida
- Austin Ear, Nose, and Throat Clinic
- San Antonio Ear, Nose, and Throat Research
- San Antonio Ear, Nose, and Throat Research
- Ear Institute of Texas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
FST-201 (dexamethasone 0.1%) Otic Suspension
vehicle
Arm Description
Outcomes
Primary Outcome Measures
Overall clinical cure as defined by absence of the signs and symptoms of AFOE including ear inflammation, edema, tenderness, pruritis and otic discharge.
Secondary Outcome Measures
Microbiological resolution defined as absence of pre-treatment pathogenic fungal species.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00945646
Brief Title
FST-201 In The Treatment of Acute Fungal Otitis Externa
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 Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Study Start Date
July 31, 2009 (Actual)
Primary Completion Date
July 31, 2010 (Actual)
Study Completion Date
July 31, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Fungal Otitis Externa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FST-201 (dexamethasone 0.1%) Otic Suspension
Arm Type
Experimental
Arm Title
vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
FST-201 (dexamethasone 0.1%) Otic Suspension
Intervention Description
Instill four drops times two times a day.
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Instill four times two times a day
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Microbiological resolution defined as absence of pre-treatment pathogenic fungal species.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
ENT Associates of South Florida
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Austin Ear, Nose, and Throat Clinic
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
San Antonio Ear, Nose, and Throat Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
San Antonio Ear, Nose, and Throat Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Ear Institute of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
12. IPD Sharing Statement
Learn more about this trial
FST-201 In The Treatment of Acute Fungal Otitis Externa
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