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FST-201 In The Treatment of Acute Otitis Externa

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Foresight Biotherapeutics
ClinicalTrials.gov Identifier:
NCT00945802
First received: July 23, 2009
Last updated: September 5, 2012
Last verified: September 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 78215
San Antonio Ear, Nose, and Throat Research
San Antonio, Texas, United States, 78229
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
Otitis Externa
Ear Diseases
Otorhinolaryngologic Diseases
BB 1101
Ciprofloxacin
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014