FST-201 In The Treatment of Acute Otitis Externa

Acute Otitis Externa Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00945802
Study type	Interventional
Source	Takeda
Contact
Status	Terminated
Phase	Phase 3
Start date	July 31, 2009
Completion date	July 31, 2010

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02918773` - Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto)	N/A
Not yet recruiting	`NCT04636957` - A Phase III Study of Ciprofloxacin Plus Fluocinolone in Acute Otitis Externa (AOE)	Phase 3
Completed	`NCT01447017` - A Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis	Phase 2
Completed	`NCT01535599` - Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa	Phase 3
Completed	`NCT02801370` - Phase 3 Study of OTO-201 in Acute Otitis Externa	Phase 3
Completed	`NCT00750633` - A Phase III Study of an Otic Formulation in Acute Otitis Externa	Phase 3
Completed	`NCT03196973` - Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa	Phase 3
Recruiting	`NCT01584271` - Study of Ear Comfort Ear Drops to Treat AOE Cases Compared to DexOtic & Otidin(R)	Phase 2
Completed	`NCT02216071` - Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa	Phase 3
Completed	`NCT00961675` - FST-201 in the Treatment of Acute Otitis Externa	Phase 3
Completed	`NCT01535560` - Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa	Phase 3