DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 media

Sponsor determined microbiological cure of otitis media

Secondary outcome:

Investigator determined clinical cure

Overall 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017