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NCT00393835 Clinical Trial

A Trial Of Azithromycin SR For The Treatment Of Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis

Upper Respiratory Tract Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00393835
Other study ID # A0661176
Secondary ID
Status Completed
Phase Phase 3
First received October 26, 2006
Last updated May 15, 2008
Start date November 2006
Est. completion date May 2007

Study information
Verified date May 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 99
Est. completion date May 2007
Est. primary completion date May 2007
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 80 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Azithromycin SR

Locations
Country Name City State
Japan Pfizer Investigational Site Gobo Wakayama
Japan Pfizer Investigational Site Hashimoto Wakayama
Japan Pfizer Investigational Site Shinjo-cho, Tanabe Wakayama
Japan Pfizer Investigational Site Wakayama
Japan Pfizer Investigational Site Wakayama

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary endpoint is Investigator's Clinical efficacy at Day 8.
Secondary 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
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