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
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00232154
Collaborator
(none)
72
18
7
4
0.6
Study Details
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 |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
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
:
Nov 1, 2005
Actual Primary Completion Date
:
Jun 1, 2006
Actual Study Completion Date
:
Jun 1, 2006
Outcome Measures
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. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Alabaster | Alabama | United States | 35007 |
| 2 | Pfizer Investigational Site | Birmingham | Alabama | United States | 35209 |
| 3 | Pfizer Investigational Site | Birmingham | Alabama | United States | 35233 |
| 4 | Pfizer Investigational Site | Birmingham | Alabama | United States | 35242 |
| 5 | Pfizer Investigational Site | Hoover | Alabama | United States | 35216 |
| 6 | Pfizer Investigational Site | Hoover | Alabama | United States | 35244 |
| 7 | Pfizer Investigational Site | Fresno | California | United States | 93720 |
| 8 | Pfizer Investigational Site | Jacksonville | Florida | United States | 32216 |
| 9 | Pfizer Investigational Site | Miami | Florida | United States | 33136-1002 |
| 10 | Pfizer Investigational Site | Augusta | Georgia | United States | 30912 |
| 11 | Pfizer Investigational Site | Elgin | Illinois | United States | 60120 |
| 12 | Pfizer Investigational Site | Elgin | Illinois | United States | 60123 |
| 13 | Pfizer Investigational Site | Maywood | Illinois | United States | 60153 |
| 14 | Pfizer Investigational Site | Carrollton | Kentucky | United States | 41008 |
| 15 | Pfizer Investigational Site | La Grange | Kentucky | United States | 40031 |
| 16 | Pfizer Investigational Site | Louisville | Kentucky | United States | 40207 |
| 17 | Pfizer Investigational Site | Durham | North Carolina | United States | 27710 |
| 18 | Pfizer Investigational Site | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00232154
Other Study ID Numbers:
- A0661151
First Posted:
Oct 4, 2005
Last Update Posted:
Apr 21, 2011
Last Verified:
Apr 1, 2011