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

NCT ID: NCT00781521

Last Updated: 2008-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2003-04-30

Brief Summary

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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

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Conditions

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Otitis Media

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Floxin otic solution twice a day for 7 days

Group Type EXPERIMENTAL

ofloxacin otic solution 0.3%

Intervention Type DRUG

ofloxacin otic solution 0.3% instilled twice a day for seven days

Interventions

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ofloxacin otic solution 0.3%

ofloxacin otic solution 0.3% instilled twice a day for seven days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Responsible Party

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Daiichi Sankyo

Other Identifiers

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8280A-PRT021

Identifier Type: -

Identifier Source: org_study_id