The Efficacy of SinoFresh Nasal and Sinus Care Nasal Spra... | NCT00790972

Studies
The Efficacy of SinoFresh Nasal and Sinus Care Nasal Spray in Eliminating MRSA From the Nasal Cavity

NCT00790972

Sponsor

University of Chicago

Status

Withdrawn

Last Update Posted

May 20, 2016Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

MRSA Infection

Interventions

Sinofresh
Placebo

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

May 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Company went out of business.

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Jun 2010Estimated

Completion Date

Jun 2013Estimated

First Submitted Date

Nov 13, 2008

First Submission Date that Met QC Criteria

Nov 13, 2008

First Posted Date

Nov 14, 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

May 19, 2016

Last Update Posted Date

May 20, 2016Estimated

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 is a study to assess the ability of SinoFresh Nasal & Sinus Care, an FDA approved over-the-counter nasal spray, to eliminate the bacteria in your nose.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	Placebo Comparator	Identical-appearing placebo	Drug: Placebo
1	Active Comparator	two sprays in each nostril three times daily for one week	Drug: Sinofresh

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sinofresh	Drug	two sprays in each nostril three times daily for one week	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
This is a study to assess the ability of SinoFresh Nasal & Sinus Care, an FDA approved over-the-counter nasal spray, to eliminate the bacteria in your nose.		7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years or older
The volunteer is able to adhere to the study requirements and study visits.
Agrees to abstain from use of other nasal sprays for length of study.
Diagnosis of an MRSA carrier by PCR testing

Exclusion Criteria:

History of chronic nose bleeds.
History of intranasal steroids in the last 2 months
Nasal obstruction severe enough to prohibit effective delivery of a nasal spray
Epistaxis
Significant excoriation in the opinion of the Investigator.
Known hypersensitivity to any ingredients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Irsk Anderson, MD	University of Chicago	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Chicago		Chicago	Illinois	60637	United States