Trials / Terminated
TerminatedNCT00945646
FST-201 In The Treatment of Acute Fungal Otitis Externa
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 Otitis Externa
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FST-201 (dexamethasone 0.1%) Otic Suspension | Instill four drops times two times a day. |
| DRUG | Vehicle | Instill four times two times a day |
Timeline
- Start date
- 2009-07-31
- Primary completion
- 2010-07-31
- Completion
- 2010-07-31
- First posted
- 2009-07-24
- Last updated
- 2021-05-27
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00945646. Inclusion in this directory is not an endorsement.