Clinical trial NCT00945802: FST-201 In The Treatment of Acute Otitis Externa
Official title: A Multi-Center, Randomized, Double-Masked Clinical Study Evaluating the Efficacy Of FST-201 (Dexamethasone 0.1%) Otic Suspension (Foresight Biotherapeutics, Inc.) Vs. Ciprodex (Ciprofloxacin 0.3%, Dexamethasone 0.1%) Otic Suspension (Alcon Laboratories, Inc.) in Subjects With Acute Otitis Externa
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute Otitis Externa
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2009-07-24
Enrollment: 5
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 Ciprodex in the treatment of acute otitis externa. This trial is designed to enable filing of a New Drug Application in support of FST-201 for the indication of acute otitis externa.


Eligibility criteria: Inclusion Criteria:

* Have a clinical diagnosis of AOE in one or both ears, defined as 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).
* Be at least 18 years of age at Visit 1 (Day 1, Screening/Baseline) of either sex and any race.
* Provide written informed consent or parental assent.
* Be willing and able to follow all instructions and attend all study visits

Exclusion Criteria:

All subjects must not:

* Have known sensitivity to any component of the study medications
* Have a current infection requiring systemic antimicrobial treatment
* Have used topical or systemic pain meds on the same day as Screening/Baseline Visit 1 and for the duration of the study.
* Take any systemic (within 30 days) or otic corticosteroids (within 1 days) prior to Screening/Baseline Visit 1
* Current use of topical or systemic non-steroidal or other anti-inflammatory drugs.
* Use any topical otic treatment with alcohol, vinegar, hydrogen peroxide or other astringent medication during the course of the study or on the same day as Screening/Baseline Visit 1
* Have taken any antibiotics within 3 days prior to Visit 1
* Have signs and symptoms of AOE for \> 4 weeks at Screening/Baseline Visit 1
* Have a non-intact or perforated tympanic membrane in the enrolled ear
* Have a clinical diagnosis of chronic suppurative otitis media, acute otitis media or acute otorrhea in patients with tympanostomy tubes
* Have a clinical diagnosis of malignant otitis externa
* Have overt fungal AOE
* Have a viral infection of the pinna or tympanic membrane (i.e herpes zoster)
* Have congenital abnormalities of the external auditory canal in the enrolled ear(s)
* Have obstructive bony exostoses in the enrolled ear(s)
* Have mastoid or other suppurative, non-infectious ear disorders (e.g, cholesteatoma)
* Have malignant tumors of the external auditory canal
* Have a history of otologic surgery. Surgery performed more than 1 year prior to Screening/Baseline Visit 1and limited to the tympanic membrane is allowed
* Have seborrheic dermatitis of the external auditory canal
* Have a current or prior history of immunosuppressive disorders
* Have acute or chronic renal insufficiency, hepatitis or diabetes mellitus
* Be pregnant, nursing or planning a pregnancy.

Primary outcomes:
measure: Overall clinical cure as defined by absence of the signs and symptoms of AOE including ear inflammation, edema, tenderness and otic discharge.
timeFrame: 1 year
Secondary outcomes:
measure: Microbiological resolution defined as elimination of pre-treatment pathogenic bacteria.
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: