A Study To Measure The Level Of Drug In Nasal Tissue And Blood After Taking A Single 2g Dose Or 500mg Tablets For Up To

NCT ID: NCT00232154

Last Updated: 2011-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-06-30

Brief Summary

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To measure the level of drug in nasal tissue and blood after taking a single 2g dose or 500mg tablets for up to 3 days.

Detailed Description

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Conditions

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Sinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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Zithromax™ (azithromycin) 500mg tablets

Intervention Type DRUG

Endoscopic Sinus Surgery

Intervention Type PROCEDURE

Blood sampling for hematology

Intervention Type PROCEDURE

Blood sampling for plasma chemistry profile

Intervention Type PROCEDURE

Serum pregnancy test (for women of child-bearing potential)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Subjects considered by the Principal Investigator as an appropriate candidate for endoscopic sinus surgery, e.g., for the removal of the thickened and diseased mucosal tissue that blocks the ostiomeatal complex (OMC).

Exclusion Criteria

* Known or suspected hypersensitivity or intolerance to any macrolide-like compound, including erythromycin, clarithromycin, azithromycin or telithromycin.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Alabaster, Alabama, United States

Site Status

Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Hoover, Alabama, United States

Site Status

Pfizer Investigational Site

Hoover, Alabama, United States

Site Status

Pfizer Investigational Site

Fresno, California, United States

Site Status

Pfizer Investigational Site

Jacksonville, Florida, United States

Site Status

Pfizer Investigational Site

Miami, Florida, United States

Site Status

Pfizer Investigational Site

Augusta, Georgia, United States

Site Status

Pfizer Investigational Site

Elgin, Illinois, United States

Site Status

Pfizer Investigational Site

Elgin, Illinois, United States

Site Status

Pfizer Investigational Site

Maywood, Illinois, United States

Site Status

Pfizer Investigational Site

Carrollton, Kentucky, United States

Site Status

Pfizer Investigational Site

La Grange, Kentucky, United States

Site Status

Pfizer Investigational Site

Louisville, Kentucky, United States

Site Status

Pfizer Investigational Site

Durham, North Carolina, United States

Site Status

Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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A0661151

Identifier Type: -

Identifier Source: org_study_id

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