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:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00232154
First received: September 30, 2005
Last updated: April 20, 2011
Last verified: April 2011
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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 May 23, 2013