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Trial record 38 of 434 for:    OTITIS

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

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. Identifier: NCT00781521
Recruitment Status : Completed
First Posted : October 29, 2008
Last Update Posted : October 29, 2008
Information provided by:
Daiichi Sankyo, Inc.

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.

Condition or disease Intervention/treatment Phase
Otitis Media Drug: ofloxacin otic solution 0.3% Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
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
Study Start Date : November 2002
Actual Primary Completion Date : April 2003
Actual Study Completion Date : April 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

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

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

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Responsible Party: Director Regulatory Affairs, Daiichi Sankyo Identifier: NCT00781521     History of Changes
Other Study ID Numbers: 8280A-PRT021
First Posted: October 29, 2008    Key Record Dates
Last Update Posted: October 29, 2008
Last Verified: October 2008
Additional relevant MeSH terms:
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Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Pharmaceutical Solutions
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