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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00781521
Other study ID # 8280A-PRT021
Secondary ID
Status Completed
Phase Phase 3
First received October 28, 2008
Last updated October 28, 2008
Start date November 2002
Est. completion date April 2003

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
ofloxacin otic solution 0.3%
ofloxacin otic solution 0.3% instilled twice a day for seven days

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Daiichi Sankyo Inc.

Outcome

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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