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TerminatedNCT00945646Updated May 27, 2021

FST-201 In The Treatment of Acute Fungal Otitis Externa

A Phase 3 interventional study of FST-201 (dexamethasone 0.1%) Otic Suspension and Vehicle in Acute Fungal Otitis Externa, sponsored by Shire. Terminated at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-27.

Sponsored by Shire · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Acute Fungal Otitis Externa
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    FST-201 (dexamethasone 0.1%) Otic Suspension

    Drug: FST-201 (dexamethasone 0.1%) Otic Suspension

  • Placebo comparator
    vehicle

    Drug: Vehicle

Interventions

  • DrugFST-201 (dexamethasone 0.1%) Otic Suspension

    Instill four drops times two times a day.

  • DrugVehicle

    Instill four times two times a day

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Microbiological resolution defined as absence of pre-treatment pathogenic fungal species.

    Time frame: 1 year

06

Study locations

6 sites
  • ENT Associates of South Florida
    Boynton Beach, Florida 33426, United States
  • Sarasota, Florida 34239, United States
  • Austin Ear, Nose, and Throat Clinic
    Austin, Texas 78705, United States
  • San Antonio Ear, Nose, and Throat Research
    San Antonio, Texas 78215, United States
  • San Antonio Ear, Nose, and Throat Research
    San Antonio, Texas 78229, United States
  • Ear Institute of Texas
    San Antonio, Texas 78258, United States
07

Registry details

Key details

Study ID
NCT00945646
Lead sponsor
Shire
Responsible party
Sponsor
First posted
Jul 24, 2009
Start date
Jul 31, 2009
Primary completion
Jul 31, 2010
Completion
Jul 31, 2010
Last update
May 27, 2021

Study contacts

Study Director
study director · Takeda

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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