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

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Otitis Media

Treatments: Drug: ofloxacin otic solution 0.3%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00781521

8280A-PRT021

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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96 participants in 1 patient group

1

Experimental group

Description:

Floxin otic solution twice a day for 7 days

Treatment:

Drug: ofloxacin otic solution 0.3%