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

A Pilot, Multicenter, Open Label, Non Comparative Study of the Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media Twice Daily for Seven Days in Children With Tympanostomy Tubes

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.

Study Overview

• Status: Completed
• Conditions: Otitis Media
• Intervention / Treatment: Drug: ofloxacin otic solution 0.3%

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; Floxin otic solution twice a day for 7 days	Drug: ofloxacin otic solution 0.3%; ofloxacin otic solution 0.3% instilled twice a day for seven days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sponsor determined clinical cure of otitis media	7 days
Sponsor determined microbiological cure of otitis media	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Daiichi Sankyo, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2002
• Primary Completion (ACTUAL): April 1, 2003
• Study Completion (ACTUAL): April 1, 2003

Study Registration Dates

• First Submitted: October 28, 2008
• First Submitted That Met QC Criteria: October 28, 2008
• First Posted (ESTIMATE): October 29, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 29, 2008
• Last Update Submitted That Met QC Criteria: October 28, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Ofloxacin
• Other Study ID Numbers: 8280A-PRT021