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

• Sponsor: Daiichi Sankyo, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00781521
• Collaborator: (none)
• Enrollment: 96
• Arm: 1
• Duration (Months): 5

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Nov 1, 2002
• Actual Primary Completion Date: Apr 1, 2003
• Actual Study Completion Date: Apr 1, 2003

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Sponsor determined clinical cure of otitis media [7 days]

2. Sponsor determined microbiological cure of otitis media [7 days]

Secondary Outcome Measures

1. Investigator determined clinical cure [7 days]

2. Overall per-subject microbiological outcome [7 days]

3. Overall per pathogen microbiological outcome [7 days]

4. sign and symptoms of otitis media [7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 12 Years
• 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Daiichi Sankyo, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00781521
• Other Study ID Numbers: 8280A-PRT021
• First Posted: Oct 29, 2008
• Last Update Posted: Oct 29, 2008
• Last Verified: Oct 1, 2008

• Additional relevant MeSH terms: Otitis; Otitis Media; Ofloxacin

Study Results

No Results Posted as of Oct 29, 2008