Clinical Trial: FST-201 in the Treatment of Acute Otitis Externa

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 LBJ Tropical Medical Center, Department of Otolaryngology, in Pago Pago, American Samoa.

Detailed Summary: The proposed clinical trial will evaluate the efficacy of FST-201 (dexamethasone 0.1% ) 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 GCP, ICH, FDA, HIPPA and Declaration of Helsinki guidelines.
Sponsor: Shire

Current Primary Outcome: Overall clinical cure as defined by absence of the signs and symptoms of AOE including ear inflammation, edema, tenderness and otic discharge. [ Time Frame: 18 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Microbiological resolution defined as elimination of pre-treatment pathogenic organism. [ Time Frame: 18 days ]

Original Secondary Outcome: Same as current

Information By: Shire

Dates:
Date Received: August 18, 2009
Date Started: August 2009
Date Completion:
Last Updated: September 14, 2015
Last Verified: September 2012