FST-201 In The Treatment of Acute Fungal Otitis Externa

Phase 3

Terminated

• Conditions: Acute Fungal Otitis Externa
• Interventions: Drug: Vehicle; Drug: FST-201 (dexamethasone 0.1%) Otic Suspension

• Registration Number: NCT00945646
• Lead Sponsor: Shire

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-23
• Study First Submitted QC: 2009-07-23
• Study First Posted: 2009-07-24
• Study Start: 2009-07-31
• Primary Completion: 2010-07-31
• Study Completion: 2010-07-31
• Disposition First Submitted: 2012-09-05
• Disposition First Submitted QC: 2012-09-05
• Disposition First Posted: 2012-09-06
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-24
• Last Update Posted: 2021-05-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vehicle	Vehicle	-
FST-201 (dexamethasone 0.1%) Otic Suspension	FST-201 (dexamethasone 0.1%) Otic Suspension	-

Primary Outcome Measures

Name	Time	Method
Overall clinical cure as defined by absence of the signs and symptoms of AFOE including ear inflammation, edema, tenderness, pruritis and otic discharge.	1 year

Secondary Outcome Measures

Name	Time	Method
Microbiological resolution defined as absence of pre-treatment pathogenic fungal species.	1 year

Trial Locations

Locations (4)

ENT Associates of South Florida; 🇺🇸 Boynton Beach, Florida, United States

Austin Ear, Nose, and Throat Clinic; 🇺🇸 Austin, Texas, United States

San Antonio Ear, Nose, and Throat Research; 🇺🇸 San Antonio, Texas, United States

Ear Institute of Texas; 🇺🇸 San Antonio, Texas, United States