FST-201 in the Treatment of Acute Otitis Externa
Information source: Foresight Biotherapeutics
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Otitis Externa
Intervention: FST201 (dexamethasone 0.1% with povidone-iodine 1%) (Drug); Ciprodex (Ciprofloxacin 0.3%; dexamethasone 0.1% ) (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Foresight Biotherapeutics Official(s) and/or principal investigator(s):
Richard Wagner, MD, Principal Investigator, Affiliation: Global ENT Outreach
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 LBJ
Tropical Medical Center, Department of Otolaryngology in Pago Pago, American Samoa.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Overall clinical cure as defined by absence of the signs and symptoms of AOE including ear inflammation, edema, tenderness and otic discharge.
Secondary outcome: Microbiological resolution defined as elimination of pre-treatment pathogenic organism.
Detailed description:
The proposed clinical trial will evaluate the efficacy of FST-201 (dexamethasone 0. 1% with
1. 0% povidone-iodine preservative) 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 GCP, ICH, FDA, HIPPA and Declaration of
Helsinki guidelines.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Male.
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
Locations and Contacts
LBJ Tropical Medical Center, Department of Otolaryngology, Pago Pago 96799, American Samoa; Recruiting
Richard Wagner, MD, Phone: 3606781383, Email: rwagner@geoutreach.org
Richard Wagner, MD, Principal Investigator
Additional Information
Starting date: August 2009
Ending date: January 2010
Last updated: August 18, 2009
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