Safety and Efficacy of Floxin Otic Solution in the Treatm... | NCT00781521

Studies
Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in Children

NCT00781521

Sponsor

Daiichi Sankyo

Status

Completed

Last Update Posted

Oct 29, 2008Estimated

Enrollment

96Actual

Phase

Phase 3

Conditions

Otitis Media

Interventions

ofloxacin otic solution 0.3%

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2002

Primary Completion Date

Apr 2003Actual

Completion Date

Apr 2003Actual

First Submitted Date

Oct 28, 2008

First Submission Date that Met QC Criteria

Oct 28, 2008

First Posted Date

Oct 29, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2008

Last Update Posted Date

Oct 29, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Floxin otic solution twice a day for 7 days	Drug: ofloxacin otic solution 0.3%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ofloxacin otic solution 0.3%	Drug	ofloxacin otic solution 0.3% instilled twice a day for seven days	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sponsor determined clinical cure of otitis media		7 days
Sponsor determined microbiological cure of otitis media		7 days

Secondary Outcomes

Measure	Description	Time Frame
Investigator determined clinical cure		7 days
Overall per-subject microbiological outcome		7 days
Overall per pathogen microbiological outcome

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010033	Otitis Media

Ancestor Terms

ID	Term
D010031	Otitis
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided