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FST-201 In The Treatment of Acute Otitis Externa

NCT00945802 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2021-05-27

No results posted yet for this study

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

  • Acute Otitis Externa

Interventions

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

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00945802 on ClinicalTrials.gov