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OpenTrials
Completed

NCT Number: NCT00781521

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

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.

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Key information

Conditions

Otitis Media Ear Diseases Otitis Otorhinolaryngologic Diseases

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ofloxacin otic solution 0.3%

Drug

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

Primary outcomes

  1. Sponsor determined clinical cure of otitis media

    Time frame: 7 days

  2. Sponsor determined microbiological cure of otitis media

    Time frame: 7 days

Secondary outcomes

  1. Investigator determined clinical cure

    Time frame: 7 days

  2. Overall per-subject microbiological outcome

    Time frame: 7 days

  3. Overall per pathogen microbiological outcome

    Time frame: 7 days

  4. sign and symptoms of otitis media

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Oct 29, 2008
Registry last updated
Oct 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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