FST-201 In The Treatment of Acute Otitis Externa

Acute Otitis Externa Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00945802
• Other study ID #: FST201-AOE-02
• Status: Terminated
• Phase: Phase 3
• Start date: July 31, 2009
• Est. completion date: July 31, 2010

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: July 31, 2010
• Est. primary completion date: July 31, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Otitis Externa
• Otitis
• Otitis Externa

Intervention

Drug:
• FST-201 (dexamethasone 0.1%) Otic Suspension
Instill four drops two times a day
• ciprofloxacin 0.3%, dexamethasone 0.1%
Instill four drops two times a day

Locations

Country	Name	City	State
United States	Austin Ear, Nose, and Throat Clinic	Austin	Texas
United States	ENT Associates of South Florida	Boynton Beach	Florida
United States	Ear Institute of Texas	San Antonio	Texas
United States	San Antonio Ear, Nose, and Throat Research	San Antonio	Texas
United States	San Antonio Ear, Nose, and Throat Research	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall clinical cure as defined by absence of the signs and symptoms of AOE including ear inflammation, edema, tenderness and otic discharge.		1 year
Secondary	Microbiological resolution defined as elimination of pre-treatment pathogenic bacteria.		1 year