Clinical trial NCT00945646: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute Fungal Otitis Externa
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2009-07-24
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overall clinical cure as defined by absence of the signs and symptoms of AFOE including ear inflammation, edema, tenderness, pruritis and otic discharge.
timeFrame: 1 year
Secondary outcomes:
measure: Microbiological resolution defined as absence of pre-treatment pathogenic fungal species.
timeFrame: 1 year
Other outcomes:
Locations:
city: Boynton Beach
country: United States
facility: ENT Associates of South Florida
state: Florida
city: Sarasota
country: United States
state: Florida
city: Austin
country: United States
facility: Austin Ear, Nose, and Throat Clinic
state: Texas
city: San Antonio
country: United States
facility: San Antonio Ear, Nose, and Throat Research
state: Texas
city: San Antonio
country: United States
facility: San Antonio Ear, Nose, and Throat Research
state: Texas
city: San Antonio
country: United States
facility: Ear Institute of Texas
state: Texas
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: