Status:
COMPLETED
Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in Children
Lead Sponsor:
Daiichi Sankyo
Conditions:
Otitis Media
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
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 approve...
Eligibility Criteria
Inclusion
- 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
- Non-bacterial otic infection
- Known or suspected hypersensitivity to ofloxacin
- Cystic fibrosis
- HIV infection
- Neutropenia
- Receiving immunosuppressive therapy
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2003
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00781521
Start Date
November 1 2002
End Date
April 1 2003
Last Update
October 29 2008
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.