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Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in Children

NCT00781521 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2008-10-29

No results posted yet for this study

Summary

This was a pilot study to determine the safety and effectiveness of a twice daily, seven-day dosing regimen in acute, pediatric, otitis media in children with tympanostomy tubes. The currently approved regimen is twice daily for 10 days.

Conditions

  • Otitis Media

Interventions

DRUG

ofloxacin otic solution 0.3%

ofloxacin otic solution 0.3% instilled twice a day for seven days

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-30
Primary Completion
2003-04-30
Completion
2003-04-30

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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 NCT00781521 on ClinicalTrials.gov