Back to resultsA Trial Of Azithromycin SR For The Treatment Of Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis
Primary Purpose
Upper Respiratory Tract Infection
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Azithromycin SR
Sponsored by
About this trial
This is an interventional treatment trial for Upper Respiratory Tract Infection
Eligibility Criteria
Inclusion Criteria:
- Patients who were diagnosed Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis
Exclusion Criteria:
- Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
The primary endpoint is Investigator's Clinical efficacy at Day 8.
Secondary Outcome Measures
Endpoints of efficacy are as follows: Investigator's clinical efficacy (at Day 4, Day 15 and 29) Bacteriological efficacy (at Day 4, 8, 15 and 29) Safety Endpoints: Adverse events and safety Laboratory data
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00393835
Brief Title
A Trial Of Azithromycin SR For The Treatment Of Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis
Official Title
A Multicenter, Non-Randomized, Open Label Trial Of Azithromycin Sustained Release (SR) For The Treatment Of Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis In Japan Adults
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
To evaluate the clinical efficacy and safety in patients with Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis receiving a dose of 2 g of azithromycin in the SR formulation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Azithromycin SR
Primary Outcome Measure Information:
Title
The primary endpoint is Investigator's Clinical efficacy at Day 8.
Secondary Outcome Measure Information:
Title
Endpoints of efficacy are as follows: Investigator's clinical efficacy (at Day 4, Day 15 and 29) Bacteriological efficacy (at Day 4, 8, 15 and 29) Safety Endpoints: Adverse events and safety Laboratory data
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who were diagnosed Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis
Exclusion Criteria:
Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Gobo
State/Province
Wakayama
ZIP/Postal Code
644-8655
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hashimoto
State/Province
Wakayama
ZIP/Postal Code
648-0053
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shinjo-cho, Tanabe
State/Province
Wakayama
ZIP/Postal Code
646-8588
Country
Japan
Facility Name
Pfizer Investigational Site
City
Wakayama
ZIP/Postal Code
640-8435
Country
Japan
Facility Name
Pfizer Investigational Site
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661176&StudyName=A%20Trial%20Of%20Azithromycin%20SR%20For%20The%20Treatment%20Of%20Laryngopharyngitis%20or%20Tonsillitis%20or%20Acute%20Bacterial%20Rhinosinusitis
Description
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Learn more about this trial
A Trial Of Azithromycin SR For The Treatment Of Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis
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