search
Back to results

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

Primary Purpose

Otitis Media

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ofloxacin otic solution 0.3%
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Otitis Media

Eligibility Criteria

6 Months - 12 Years (Child)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    Floxin otic solution twice a day for 7 days

    Outcomes

    Primary Outcome Measures

    Sponsor determined clinical cure of otitis media
    Sponsor determined microbiological cure of otitis media

    Secondary Outcome Measures

    Investigator determined clinical cure
    Overall per-subject microbiological outcome
    Overall per pathogen microbiological outcome
    sign and symptoms of otitis media

    Full Information

    First Posted
    October 28, 2008
    Last Updated
    October 28, 2008
    Sponsor
    Daiichi Sankyo, Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00781521
    Brief Title
    Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in Children
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2002 (undefined)
    Primary Completion Date
    April 2003 (Actual)
    Study Completion Date
    April 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Daiichi Sankyo, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Otitis Media

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    96 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Floxin otic solution twice a day for 7 days
    Intervention Type
    Drug
    Intervention Name(s)
    ofloxacin otic solution 0.3%
    Intervention Description
    ofloxacin otic solution 0.3% instilled twice a day for seven days
    Primary Outcome Measure Information:
    Title
    Sponsor determined clinical cure of otitis media
    Time Frame
    7 days
    Title
    Sponsor determined microbiological cure of otitis media
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    Investigator determined clinical cure
    Time Frame
    7 days
    Title
    Overall per-subject microbiological outcome
    Time Frame
    7 days
    Title
    Overall per pathogen microbiological outcome
    Time Frame
    7 days
    Title
    sign and symptoms of otitis media
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs