FST-201 In The Treatment of Acute Otitis Externa - Full Text View

Purpose

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.

Condition	Intervention	Phase
Acute Otitis Externa	Drug: FST-201 (dexamethasone 0.1%) Otic Suspension Drug: ciprofloxacin 0.3%, dexamethasone 0.1%	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone sodium phosphate Ciprofloxacin Ciprofloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Foresight Biotherapeutics:

Primary Outcome Measures:

Overall clinical cure as defined by absence of the signs and symptoms of AOE including ear inflammation, edema, tenderness and otic discharge. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Microbiological resolution defined as elimination of pre-treatment pathogenic bacteria. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment:	5
Study Start Date:	July 2009
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: FST-201 (dexamethasone 0.1%) Otic Suspension	Drug: FST-201 (dexamethasone 0.1%) Otic Suspension Instill four drops two times a day
Active Comparator: ciprofloxacin 0.3%, dexamethasone 0.1%	Drug: ciprofloxacin 0.3%, dexamethasone 0.1% Instill four drops two times a day Other Name: Ciprodex

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00945802

Locations

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
Ear Institute of Texas
San Antonio, Texas, United States, 78258
San Antonio Ear, Nose, and Throat Research
San Antonio, Texas, United States, 78229
San Antonio Ear, Nose, and Throat Research
San Antonio, Texas, United States, 78215

Sponsors and Collaborators

Foresight Biotherapeutics

More Information

No publications provided

Responsible Party:	Foresight Biotherapeutics
ClinicalTrials.gov Identifier:	NCT00945802 History of Changes
Other Study ID Numbers:	FST201-AOE-02
Study First Received:	July 23, 2009
Last Updated:	September 5, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Otitis Externa
Otitis
Ear Diseases
Otorhinolaryngologic Diseases
Ciprofloxacin
BB 1101
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents

Therapeutic Uses
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013