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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00232154
First received: September 30, 2005
Last updated: April 20, 2011
Last verified: April 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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.

Enrollment: 72
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
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:
No publications provided

ClinicalTrials.gov Identifier: NCT00232154     History of Changes
Other Study ID Numbers: A0661151
Study First Received: September 30, 2005
Last Updated: April 20, 2011
Health Authority: United States: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014