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Clinical Trials/NCT00781521
NCT00781521
Completed
Phase 3

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

Daiichi Sankyo0 sites96 target enrollmentNovember 2002
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ConditionsOtitis Media
Interventionsofloxacin otic solution 0.3%
Drugsofloxacin otic solution 0.3%

Overview

Phase
Phase 3
Intervention
ofloxacin otic solution 0.3%
Conditions
Otitis Media
Sponsor
Daiichi Sankyo
Enrollment
96
Primary Endpoint
Sponsor determined clinical cure of otitis media
Status
Completed
Last Updated
17 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2002
End Date
April 2003
Last Updated
17 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

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

Arms & Interventions

1

Floxin otic solution twice a day for 7 days

Intervention: ofloxacin otic solution 0.3%

Outcomes

Primary Outcomes

Sponsor determined clinical cure of otitis media

Time Frame: 7 days

Sponsor determined microbiological cure of otitis media

Time Frame: 7 days

Secondary Outcomes

  • 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)

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