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NCT00360464 Clinical Trial

A Trial Of Azithromycin SR For The Treatment Of Acute Bronchitis And Secondary Infection Of Chronic Respiratory Diseases

Acute Bronchitis Clinical Trial

Official title:
A Multicenter, Non-Randomized, Open Label Trial Of Azithromycin SR For The Treatment Of Acute Bronchitis And Secondary Infection Of Chronic Respiratory Diseases In Japan Adults

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00360464
Other study ID # A0661175
Secondary ID
Status Completed
Phase Phase 3
First received August 3, 2006
Last updated April 20, 2011
Start date October 2006
Est. completion date June 2007

Study information
Verified date April 2011
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 Acute Bronchitis or Secondary Infection of Chronic Respiratory Diseases receiving a dose of 2 g of azithromycin in the SR formulation.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients who were diagnosed as mild or moderate in severity by the classification of infection of the Japanese Society of Chemotherapy guidelines for the evaluation methods of new antibacterial drug (established in 1997).

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 Akiruno Tokyo
Japan Pfizer Investigational Site Chofu Tokyo
Japan Pfizer Investigational Site Chofu Tokyo
Japan Pfizer Investigational Site Hitachinaka Ibaraki
Japan Pfizer Investigational Site Kami-gun Miyagi
Japan Pfizer Investigational Site Kasama Ibaraki
Japan Pfizer Investigational Site Katano Osaka
Japan Pfizer Investigational Site Kodaira Tokyo
Japan Pfizer Investigational Site Moriya Ibaraki
Japan Pfizer Investigational Site Nakano Tokyo
Japan Pfizer Investigational Site Setagaya Tokyo
Japan Pfizer Investigational Site Shigesato-cho, Nagasaki Nagasaki
Japan Pfizer Investigational Site Shinagawa Tokyo
Japan Pfizer Investigational Site Shindoori, Niigata-shi Niigata
Japan Pfizer Investigational Site Toride Ibaraki
Japan Pfizer Investigational Site Tsuchiura Ibaraki
Japan Pfizer Investigational Site Yokohama Kanagawa
Japan Pfizer Investigational Site Yokosuka Kangawa
Japan Pfizer Investigational Site Yonezawa Yamagata

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 15 and 29), and the tendency toward clinical improvement (at Day 4); Bacteriological efficacy (at Day 4, 8, 15 and 29); Safety Endpoints: Adverse events and safety lab data.
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