FST-201 In The Treatment of Acute Otitis Externa

NCT00945802 | Terminated Phase 3

• 1 other identifier: FST201-AOE-02
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 6

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 support of FST-201 for the indication of acute otitis externa.

Conditions

Acute Otitis Externa

Outcome Measures

Primary Outcomes (1)

• Overall clinical cure as defined by absence of the signs and symptoms of AOE including ear inflammation, edema, tenderness and otic discharge.

  1 year

Secondary Outcomes (1)

• Microbiological resolution defined as elimination of pre-treatment pathogenic bacteria.

  1 year

Study Arms (2)

FST-201 (dexamethasone 0.1%) Otic Suspension

EXPERIMENTAL

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

ciprofloxacin 0.3%, dexamethasone 0.1%

ACTIVE COMPARATOR

Drug: ciprofloxacin 0.3%, dexamethasone 0.1%

Interventions

FST-201 (dexamethasone 0.1%) Otic Suspension DRUG

Instill four drops two times a day

FST-201 (dexamethasone 0.1%) Otic Suspension

ciprofloxacin 0.3%, dexamethasone 0.1% DRUG

Instill four drops two times a day

Also known as: Ciprodex

ciprofloxacin 0.3%, dexamethasone 0.1%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shire: lead

Study Sites (6)

ENT Associates of South Florida

Boynton Beach, Florida, 33426, United States

Location

Unknown Facility

Sarasota, Florida, 34239, United States

Location

Austin Ear, Nose, and Throat Clinic

Austin, Texas, 78705, United States

Location

San Antonio Ear, Nose, and Throat Research

San Antonio, Texas, 78215, United States

Location

San Antonio Ear, Nose, and Throat Research

San Antonio, Texas, 78229, United States

Location

Ear Institute of Texas

San Antonio, Texas, 78258, United States

Location

MeSH Terms

Interventions

Dexamethasone; Ciprofloxacin

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2009
• First Posted: July 24, 2009
• Study Start: July 31, 2009
• Primary Completion: July 31, 2010
• Study Completion: July 31, 2010
• Last Updated: May 27, 2021

Record last verified: 2021-05

Locations

US (6)