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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00232154
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : April 21, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment 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 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Study Start Date : November 2005
Primary Completion Date : June 2006
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. To assess the safety of azithromycin extended release for oral suspension and azithromycin 500mg tablets.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Jacksonville, Florida, United States, 32216
Pfizer Investigational Site
Miami, Florida, United States, 33136-1002
United States, Georgia
Pfizer Investigational Site
Augusta, Georgia, United States, 30912
United States, Illinois
Pfizer Investigational Site
Elgin, Illinois, United States, 60120
Pfizer Investigational Site
Elgin, Illinois, United States, 60123
Pfizer Investigational Site
Maywood, Illinois, United States, 60153
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:
ClinicalTrials.gov Identifier: NCT00232154     History of Changes
Other Study ID Numbers: A0661151
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: April 21, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents