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

Otitis Media Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00781521
• Other study ID #: 8280A-PRT021
• Status: Completed
• Phase: Phase 3
• First received: October 28, 2008
• Last updated: October 28, 2008
• Start date: November 2002
• Est. completion date: April 2003

Study information

• Verified date: October 2008
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: April 2003
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 12 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Otitis
• Otitis Media

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sponsor determined clinical cure of otitis media		7 days	No
Primary	Sponsor determined microbiological cure of otitis media		7 days	No
Secondary	Investigator determined clinical cure		7 days	No
Secondary	Overall per-subject microbiological outcome		7 days	No
Secondary	Overall per pathogen microbiological outcome		7 days	No
Secondary	sign and symptoms of otitis media		7 days	No