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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:
ClinicalTrials.gov Identifier:
NCT00781521
First Posted: October 29, 2008
Last Update Posted: October 29, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Daiichi Sankyo, Inc.
  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: None (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:


Further study details as provided by Daiichi Sankyo, Inc.:

Primary Outcome Measures:
  • Sponsor determined clinical cure of otitis media [ Time Frame: 7 days ]
  • Sponsor determined microbiological cure of otitis media [ Time Frame: 7 days ]

Secondary Outcome 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
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

Responsible Party: Director Regulatory Affairs, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00781521     History of Changes
Other Study ID Numbers: 8280A-PRT021
First Submitted: October 28, 2008
First Posted: October 29, 2008
Last Update Posted: October 29, 2008
Last Verified: October 2008

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Pharmaceutical Solutions
Ofloxacin
Levofloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors