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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2003

Interventions

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

Arms, Groups and Cohorts

  • Experimental: 1
    • Floxin otic solution twice a day for 7 days

Clinical Trial Outcome Measures

Primary Measures

  • Sponsor determined clinical cure of otitis media
    • Time Frame: 7 days
  • Sponsor determined microbiological cure of otitis media
    • Time Frame: 7 days

Secondary Measures

  • Investigator determined clinical cure
    • Time Frame: 7 days
  • Overall per-subject microbiological outcome
    • Time Frame: 7 days
  • Overall per pathogen microbiological outcome
    • Time Frame: 7 days
  • sign and symptoms of otitis media
    • Time Frame: 7 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Daiichi Sankyo
  • Provider of Information About this Clinical Study
    • Director Regulatory Affairs, Daiichi Sankyo

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