NCT00961675

FST-201 in the Treatment of Acute Otitis Externa

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Shire · Industry
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Otitis Externa

Interventions

Type	Name	Description
DRUG	FST201 (dexamethasone 0.1% with povidone-iodine 1%)	4 gtt BID (twice a day)
DRUG	Ciprodex (Ciprofloxacin 0.3%; dexamethasone 0.1% )	4 gtt BID (twice a day)

Timeline

• Start date: 2009-08-31
• Primary completion: 2010-06-30
• Completion: 2010-06-30
• First posted: 2009-08-19
• Last updated: 2021-06-14

Locations

1 site across 1 country: American Samoa