Safety and Efficacy of Moxidex Otic | NCT01071902

Studies
Safety and Efficacy of Moxidex Otic

NCT01071902

Sponsor

Alcon Research

Status

Terminated

Last Update Posted

Dec 3, 2012Estimated

Enrollment

400Actual

Phase

Phase 3

Conditions

Acute Otitis Media

Interventions

Moxidex otic solution
Moxifloxacin otic solution
Vehicle
Tympanostomy tubes

Countries

United States

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

Nov 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Management decision

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Feb 18, 2010

First Submission Date that Met QC Criteria

Feb 18, 2010

First Posted Date

Feb 19, 2010Estimated

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

Nov 28, 2012

Certification/Extension First Submitted that Passed QC Review

Nov 28, 2012

Certification/Extension First Posted Date

Nov 30, 2012Estimated

Last Update Submitted Date

Nov 29, 2012

Last Update Posted Date

Dec 3, 2012Estimated

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

The purpose of this study is to determine if Moxidex otic solution is safe and effective in treating middle ear infections in patients with ear tubes.

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

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Moxidex	Experimental	Moxidex otic solution	Drug: Moxidex otic solution Device: Tympanostomy tubes
Moxifloxacin	Active Comparator	Moxifloxacin otic solution	Drug: Moxifloxacin otic solution Device: Tympanostomy tubes
Vehicle	Placebo Comparator	Vehicle	Other: Vehicle Device: Tympanostomy tubes

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Moxidex otic solution	Drug	4 drops into the infected ear(s) twice daily (morning and evening) for 7 days	Moxidex

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Cure at End of Treatment		Day 8

Secondary Outcomes

Measure	Description	Time Frame
Time to Cessation of Otorrhea		From First Dose
Microbiological Success at End of Treatment		Day 8

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

6 months to 12 years of age
Ear tubes in one or both ears
Ear drainage visible by parent/guardian
Ear drainage less than 21 days
Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

Patients not otorrhea-free for 7 or less following tympanostomy tube surgery
Ear tube with antimicrobial activity; ear tube longer than 2.5mm
Non-tube otorrhea
No otic surgery other than tube placement in the last year
No menarchial females; no diabetic patients
No patients with any disease or condition that would negatively affect the conduct of the study
No patients taking any other systemic antimicrobial therapy during the study
Patient must meet certain medication washouts to be eligible
Analgesic use (other than acetaminophen) is not allowed
Patients may not be predisposed to neurosensory hearing loss
Other protocol-defined exclusion criteria may apply

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Contact Alcon Call Center	1-888-451-3937	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Contact Alcon Call Center for Trial Locations		Fort Worth	Texas	76134	United States

Condition Browse Module

MeSH Terms

ID	Term
D010033	Otitis Media
D010031	Otitis

Ancestor Terms

ID	Term
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided