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

NCT ID: NCT00360464

Last Updated: 2011-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Bronchitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Azithromycin SR

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Hitachi-Naka, Ibaraki, Japan

Site Status

Pfizer Investigational Site

Kasama, Ibaraki, Japan

Site Status

Pfizer Investigational Site

Moriya, Ibaraki, Japan

Site Status

Pfizer Investigational Site

Toride, Ibaraki, Japan

Site Status

Pfizer Investigational Site

Tsuchiura, Ibaraki, Japan

Site Status

Pfizer Investigational Site

Yokohama, Kanagawa, Japan

Site Status

Pfizer Investigational Site

Yokosuka, Kangawa, Japan

Site Status

Pfizer Investigational Site

Kami-gun, Miyagi, Japan

Site Status

Pfizer Investigational Site

Shigesato-cho, Nagasaki, Nagasaki, Japan

Site Status

Pfizer Investigational Site

Shindoori, Niigata-shi, Niigata, Japan

Site Status

Pfizer Investigational Site

Katano, Osaka, Japan

Site Status

Pfizer Investigational Site

Akiruno, Tokyo, Japan

Site Status

Pfizer Investigational Site

Chōfu, Tokyo, Japan

Site Status

Pfizer Investigational Site

Chōfu, Tokyo, Japan

Site Status

Pfizer Investigational Site

Kodaira, Tokyo, Japan

Site Status

Pfizer Investigational Site

Nakano City, Tokyo, Japan

Site Status

Pfizer Investigational Site

Setagaya City, Tokyo, Japan

Site Status

Pfizer Investigational Site

Shinagawa, Tokyo, Japan

Site Status

Pfizer Investigational Site

Yonezawa, Yamagata, Japan

Site Status

Countries

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Japan

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661175&StudyName=A%20Trial%20Of%20Azithromycin%20SR%20For%20The%20Treatment%20Of%20Acute%20Bronchitis%20And%20Secondary%20Infection%20Of%20Chronic%20Respiratory%20Diseases

To obtain contact information for a study center near you, click here.

Other Identifiers

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A0661175

Identifier Type: -

Identifier Source: org_study_id

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