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NCT00232154 Clinical Trial

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

Sinusitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00232154
Other study ID # A0661151
Secondary ID
Status Completed
Phase Phase 2
First received September 30, 2005
Last updated April 20, 2011
Start date November 2005
Est. completion date June 2006

Study information
Verified date April 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date June 2006
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• Zithromax™ (azithromycin) 500mg tablets

Procedure:
• Endoscopic Sinus Surgery

• Blood sampling for hematology

• Blood sampling for plasma chemistry profile

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

Locations
Country Name City State
United States Pfizer Investigational Site Alabaster Alabama
United States Pfizer Investigational Site Augusta Georgia
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Carrollton Kentucky
United States Pfizer Investigational Site Durham North Carolina
United States Pfizer Investigational Site Elgin Illinois
United States Pfizer Investigational Site Elgin Illinois
United States Pfizer Investigational Site Fresno California
United States Pfizer Investigational Site Hoover Alabama
United States Pfizer Investigational Site Hoover Alabama
United States Pfizer Investigational Site Jacksonville Florida
United States Pfizer Investigational Site La Grange Kentucky
United States Pfizer Investigational Site Louisville Kentucky
United States Pfizer Investigational Site Maywood Illinois
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 To assess the safety of azithromycin extended release for oral suspension and azithromycin 500mg tablets.
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