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FST-201 in the Treatment of Acute Otitis Externa

NCT00961675 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-06-14

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 study will be conducted at one site, the Lyndon B. Johnson (LBJ) Tropical Medical Center, Department of Otolaryngology, in Pago Pago, American Samoa.

Conditions

  • Acute Otitis Externa

Interventions

DRUG

FST201 (dexamethasone 0.1% with povidone-iodine 1%)

4 gtt BID (twice a day)

DRUG

Ciprodex (Ciprofloxacin 0.3%; dexamethasone 0.1% )

4 gtt BID (twice a day)

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • American Samoa

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 NCT00961675 on ClinicalTrials.gov