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

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00781521
First received: October 28, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Otitis Media
 Drug: ofloxacin otic solution 0.3%
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Ear Infections
U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Sponsor determined clinical cure of otitis media [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Sponsor determined microbiological cure of otitis media [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Investigator determined clinical cure [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Overall per-subject microbiological outcome [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Overall per pathogen microbiological outcome [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • sign and symptoms of otitis media [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 96
Study Start Date: November 2002
Study Completion Date: April 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Floxin otic solution twice a day for 7 days
 Drug: ofloxacin otic solution 0.3%
ofloxacin otic solution 0.3% instilled twice a day for seven days

  Eligibility

Ages Eligible for Study:   6 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Director Regulatory Affairs, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00781521     History of Changes
Other Study ID Numbers: 8280A-PRT021
Study First Received: October 28, 2008
Last Updated: October 28, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on May 16, 2013