Trials / Terminated
TerminatedNCT00945802
FST-201 In The Treatment of Acute Otitis Externa
A Multi-Center, Randomized, Double-Masked Clinical Study Evaluating the Efficacy Of FST-201 (Dexamethasone 0.1%) Otic Suspension (Foresight Biotherapeutics, Inc.) Vs. Ciprodex (Ciprofloxacin 0.3%, Dexamethasone 0.1%) Otic Suspension (Alcon Laboratories, Inc.) in Subjects With Acute Otitis Externa
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 5 (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 Ciprodex in the treatment of acute otitis externa. This trial is designed to enable filing of a New Drug Application in support of FST-201 for the indication of acute otitis externa.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FST-201 (dexamethasone 0.1%) Otic Suspension | Instill four drops two times a day |
| DRUG | ciprofloxacin 0.3%, dexamethasone 0.1% | Instill four drops 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 NCT00945802. Inclusion in this directory is not an endorsement.