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
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 |
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.
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 |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Daiichi Sankyo Inc. |
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 |
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