Overview

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