Clinical Trial: FST-201 In The Treatment of Acute Fungal Otitis Externa

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled Clinical Study Evaluating the Efficacy Of FST-201 (Dexamethasone 0.1%) Otic Suspension in Subjects With Acute Fungal

Brief Summary: The objective of this study is to evaluate the efficacy of FST-201 compared to vehicle in the treatment of acute fungal otitis externa. This trial is designed to enable filing of a New Drug Application in support of FST-201 for the indication of acute fungal otitis externa.

Detailed Summary:
Sponsor: Shire

Current Primary Outcome: Overall clinical cure as defined by absence of the signs and symptoms of AFOE including ear inflammation, edema, tenderness, pruritis and otic discharge. [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Microbiological resolution defined as absence of pre-treatment pathogenic fungal species. [ Time Frame: 1 year ]

Original Secondary Outcome: Same as current

Information By: Shire

Dates:
Date Received: July 23, 2009
Date Started: July 2009
Date Completion:
Last Updated: September 14, 2015
Last Verified: September 2012