Otitis Media
Conditions
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.
Interventions
DRUGofloxacin otic solution 0.3%
ofloxacin otic solution 0.3% instilled twice a day for seven days
Sponsors
Daiichi Sankyo
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 12 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sponsor determined microbiological cure of otitis media | 7 days |
| Sponsor determined clinical cure of otitis media | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Investigator determined clinical cure | 7 days |
| Overall per-subject microbiological outcome | 7 days |
| Overall per pathogen microbiological outcome | 7 days |
| sign and symptoms of otitis media | 7 days |
Outcome results
None listed