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

Phase 3

Completed

• Conditions: Otitis Media
• Interventions: Drug: ofloxacin otic solution 0.3%

• Registration Number: NCT00781521
• Lead Sponsor: Daiichi Sankyo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Primary Completion: 2003-04
• Study Completion: 2003-04
• Status Verified: 2008-10
• Study First Submitted: 2008-10-28
• Study First Submitted QC: 2008-10-28
• Last Update Submitted: 2008-10-28
• Study First Posted: 2008-10-29
• Last Update Posted: 2008-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Male or female
• 6 months of age to <12 years of age
• weight = or >4.5 kg
• Patent tympanostomy tube(s) in the affected ear(s)
• Purulent or mucopurulent otorrhea of recent onset of presumed bacterial origin

Exclusion Criteria

• Non-bacterial otic infection
• Known or suspected hypersensitivity to ofloxacin
• Cystic fibrosis
• HIV infection
• Neutropenia
• Receiving immunosuppressive therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	ofloxacin otic solution 0.3%	Floxin otic solution twice a day for 7 days

Primary Outcome Measures

Name	Time	Method
Sponsor determined clinical cure of otitis media	7 days
Sponsor determined microbiological cure of otitis media	7 days

Secondary Outcome Measures

Name	Time	Method
Investigator determined clinical cure	7 days
Overall per-subject microbiological outcome	7 days
Overall per pathogen microbiological outcome	7 days
sign and symptoms of otitis media	7 days