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

• Status: Completed
• Trial end date: 2003-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Levofloxacin; Ofloxacin; Pharmaceutical Solutions

Criteria

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