Trials / Completed
CompletedNCT00781521
Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in Children
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 96 (actual)
- Sponsor
- Daiichi Sankyo · Industry
- Sex
- All
- Age
- 6 Months – 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ofloxacin otic solution 0.3% | ofloxacin otic solution 0.3% instilled twice a day for seven days |
Timeline
- Start date
- 2002-11-01
- Primary completion
- 2003-04-01
- Completion
- 2003-04-01
- First posted
- 2008-10-29
- Last updated
- 2008-10-29
Source: ClinicalTrials.gov record NCT00781521. Inclusion in this directory is not an endorsement.