Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in Children - Full Text View

Sponsored by:	Daiichi Sankyo Inc.
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00781521

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 III

MedlinePlus related topics: Ear Infections

Drug Information available for: Levofloxacin Ofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment
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

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
1: Experimental 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

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

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Otitis
Ofloxacin
Otitis Media
Ear Diseases

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Infective Agents, Urinary

Enzyme Inhibitors
Renal Agents
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009