NCT00781521

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2002

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2008

Completed
Last Updated

October 29, 2008

Status Verified

October 1, 2008

Enrollment Period

5 months

First QC Date

October 28, 2008

Last Update Submit

October 28, 2008

Conditions

Otitis Media

Outcome Measures

Primary Outcomes (2)

  • Sponsor determined clinical cure of otitis media

    7 days

  • Sponsor determined microbiological cure of otitis media

    7 days

Secondary Outcomes (4)

  • 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

Study Arms (1)

1

EXPERIMENTAL

Floxin otic solution twice a day for 7 days

Drug: ofloxacin otic solution 0.3%

Interventions

ofloxacin otic solution 0.3%DRUG

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

1

Eligibility Criteria

Age6 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male or female
  • 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

You may not qualify if:

  • Non-bacterial otic infection
  • Known or suspected hypersensitivity to ofloxacin
  • Cystic fibrosis
  • HIV infection
  • Neutropenia
  • Receiving immunosuppressive therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 28, 2008

First Posted

October 29, 2008

Study Start

November 1, 2002

Primary Completion

April 1, 2003

Study Completion

April 1, 2003

Last Updated

October 29, 2008

Record last verified: 2008-10