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FST-201 in the Treatment of Acute Otitis Externa

Primary Purpose

Acute Otitis Externa

Status

Completed

Phase

Phase 3

Locations

American Samoa

Study Type

Interventional

Intervention

FST201 (dexamethasone 0.1% with povidone-iodine 1%)

Ciprodex (Ciprofloxacin 0.3%; dexamethasone 0.1% )

About this trial

This is an interventional treatment trial for Acute Otitis Externa focused on measuring otitis, acute, externa, ear

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Study participants must:

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

Exclusion Criteria:

Study participants 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 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
Be pregnant, nursing or planning a pregnancy

Sites / Locations

LBJ Tropical Medical Center, Department of Otolaryngology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

FST201

Ciprodex

Arm Description

Outcomes

Primary Outcome Measures

Overall clinical cure as defined by absence of the signs and symptoms of Acute Otitis Externa (AOE) including ear inflammation, edema, tenderness and otic discharge.

Secondary Outcome Measures

Microbiological resolution defined as elimination of pre-treatment pathogenic organism.

Full Information

NCT ID

NCT00961675

First Posted

August 18, 2009

Last Updated

June 9, 2021

Sponsor

Shire

1. Study Identification

Unique Protocol Identification Number

NCT00961675

Brief Title

FST-201 in the Treatment of Acute Otitis Externa

Official Title

A Phase III Clinical Study Evaluating the Efficacy Of FST-201 Otic Suspension (Foresight Biotherapeutics, Inc.) Vs. Ciprodex Otic Suspension (Alcon Laboratories, Inc.) in Subjects With Acute Otitis Externa

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

August 31, 2009 (Actual)

Primary Completion Date

June 30, 2010 (Actual)

Study Completion Date

June 30, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shire

4. Oversight

Data Monitoring Committee

5. Study Description

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 study will be conducted at one site, the Lyndon B. Johnson (LBJ) Tropical Medical Center, Department of Otolaryngology, in Pago Pago, American Samoa.

Detailed Description

The proposed clinical trial will evaluate the efficacy of FST-201 (dexamethasone 0.1% with povidone-iodine 1% ) Otic Suspension vs. the FDA-approved drug Ciprodex (ciprofloxacin 0.3%, dexamethasone 0.1%) Otic Suspension (Alcon Laboratories, Inc.) in the treatment of acute otitis externa. Acute otitis externa is a common inflammatory condition of the external auditory canal often associated with infection, allergy and dermatitis. The active ingredient in our novel dexamethasone suspension is identical in concentration and route of administration to the steroid component of the approved drug Ciprodex, which is currently the most widely-prescribed dexamethasone-containing agent in the treatment of acute otitis externa. We will enroll 60 patients (30 each in two separate treatment groups) in this trial. All patients electing to participate in this study will receive either FST-201 or Ciprodex. FST-201 and Ciprodex will be masked and provided free of charge to all study participants. Patients will be followed for at least 15 days or until their ear inflammation is either resolved or determined to need additional interventions. The study will be conducted with attention to all relevant Good Clinical Practice (GCP), International Conference on Harmonization (ICH), FDA, Health Insurance Portability and Accountability Act (HIPPA) and Declaration of Helsinki guidelines.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Otitis Externa

Keywords

otitis, acute, externa, ear

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FST201

Arm Type

Active Comparator

Arm Title

Ciprodex

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

FST201 (dexamethasone 0.1% with povidone-iodine 1%)

Intervention Description

4 gtt BID (twice a day)

Intervention Type

Drug

Intervention Name(s)

Ciprodex (Ciprofloxacin 0.3%; dexamethasone 0.1% )

Other Intervention Name(s)

CIPRODEX® (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension

Intervention Description

4 gtt BID (twice a day)

Primary Outcome Measure Information:

Title

Overall clinical cure as defined by absence of the signs and symptoms of Acute Otitis Externa (AOE) including ear inflammation, edema, tenderness and otic discharge.

Time Frame

18 days

Secondary Outcome Measure Information:

Title

Microbiological resolution defined as elimination of pre-treatment pathogenic organism.

Time Frame

18 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Study participants must: 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 Exclusion Criteria: Study participants 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 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 Be pregnant, nursing or planning a pregnancy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Director

Organizational Affiliation

Takeda

Official's Role

Study Director

Facility Information:

Facility Name

LBJ Tropical Medical Center, Department of Otolaryngology

City

Pago Pago

ZIP/Postal Code

96799

Country

American Samoa

12. IPD Sharing Statement

Learn more about this trial

FST-201 in the Treatment of Acute Otitis Externa

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