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Status:

TERMINATED

FST-201 In The Treatment of Acute Otitis Externa

Lead Sponsor:

Shire

Conditions:

Acute Otitis Externa

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 s...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

July 31 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 31 2010

Estimated Enrollment :

5 Patients enrolled

Trial Details

Trial ID

NCT00945802

Start Date

July 31 2009

End Date

July 31 2010

Last Update

May 27 2021

Active Locations (6)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (6 locations)

1

ENT Associates of South Florida

Boynton Beach, Florida, United States, 33426

2

Sarasota, Florida, United States, 34239

3

Austin Ear, Nose, and Throat Clinic

Austin, Texas, United States, 78705

4

San Antonio Ear, Nose, and Throat Research

San Antonio, Texas, United States, 78215