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 - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00232154

Purpose

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.

Condition	Intervention	Phase
Sinusitis	Drug: Zithromax (azithromycin) 500mg tablets Procedure: Endoscopic Sinus Surgery Procedure: Blood sampling for hematology Procedure: Blood sampling for plasma chemistry profile Procedure: Serum pregnancy test (for women of child-bearing potential)	Phase II

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
Official Title:	An Open-Label Study Of Azithromycin Pharmacokinetics In Sinus Mucosal Tissue And Plasma In Subjects With Chronic Rhinosinusitis Following A Single 2g Dose Of Azithromycin Extended Release For Oral Suspension Or Azithromycin 500mg Tablet Formulation Once Daily For A Maximum Of Three Days

Resource links provided by NLM:

MedlinePlus related topics: Sinusitis

Drug Information available for: Azithromycin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

To characterize the pharmacokinetics of azithromycin in sinus mucosal tissue and plasma in adult subjects after treatment with a single 2 g oral dose of azithromycin extended release for oral suspension or oral azithromycin 500 mg tablet

Secondary Outcome Measures:

To assess the safety of azithromycin extended release for oral suspension and azithromycin 500mg tablets.

Estimated Enrollment:	96
Study Start Date:	November 2005
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232154

Locations

United States, Alabama
Pfizer Investigational Site
Alabaster, Alabama, United States, 35007
Pfizer Investigational Site
Birmingham, Alabama, United States, 35209
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
Pfizer Investigational Site
Birmingham, Alabama, United States, 35242
Pfizer Investigational Site
Hoover, Alabama, United States, 35216
Pfizer Investigational Site
Hoover, Alabama, United States, 35244
United States, California
Pfizer Investigational Site
Fresno, California, United States, 93720
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33136-1002
Pfizer Investigational Site
Jacksonville, Florida, United States, 32216
United States, Georgia
Pfizer Investigational Site
Augusta, Georgia, United States, 30912
United States, Illinois
Pfizer Investigational Site
Maywood, Illinois, United States, 60153
Pfizer Investigational Site
Elgin, Illinois, United States, 60120
Pfizer Investigational Site
Elgin, Illinois, United States, 60123
United States, Kentucky
Pfizer Investigational Site
Carrollton, Kentucky, United States, 41008
Pfizer Investigational Site
La Grange, Kentucky, United States, 40031
Pfizer Investigational Site
Louisville, Kentucky, United States, 40207
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	A0661151
Study First Received:	September 30, 2005
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00232154 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Paranasal Sinus Diseases

Therapeutic Uses
Azithromycin
Sinusitis
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on February 08, 2010