FST-201 In The Treatment of Acute Fungal Otitis Externa

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Foresight Biotherapeutics
ClinicalTrials.gov Identifier:
NCT00945646
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 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.


Condition Intervention Phase
Acute Fungal Otitis Externa
Drug: FST-201 (dexamethasone 0.1%) Otic Suspension
Drug: Vehicle
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, Vehicle-Controlled Clinical Study Evaluating the Efficacy Of FST-201 (Dexamethasone 0.1%) Otic Suspension in Subjects With Acute Fungal 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 AFOE including ear inflammation, edema, tenderness, pruritis and otic discharge. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Microbiological resolution defined as absence of pre-treatment pathogenic fungal species. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 6
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 times two times a day.
Placebo Comparator: vehicle Drug: Vehicle
Instill four times two times a day

  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 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
  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: NCT00945646

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: NCT00945646     History of Changes
Other Study ID Numbers: FST201-AFOE-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
Otomycosis
Ear Diseases
Otorhinolaryngologic Diseases
Mycoses
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 11, 2014