Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in Children
Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Otitis Media
Intervention: ofloxacin otic solution 0.3% (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Daiichi Sankyo Inc.
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.
Clinical Details
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 design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Sponsor determined clinical cure of otitis mediaSponsor determined microbiological cure of otitis media
Secondary outcome: Investigator determined clinical cureOverall per-subject microbiological outcome Overall per pathogen microbiological outcome sign and symptoms of otitis media
Eligibility
Minimum age: 6 Months.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: November 2002
Last updated: October 28, 2008
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