- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00360464
A Trial Of Azithromycin SR For The Treatment Of Acute Bronchitis And Secondary Infection Of Chronic Respiratory Diseases
April 20, 2011 updated by: Pfizer
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ibaraki
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Hitachinaka, Ibaraki, Japan, 312-0057
- Pfizer Investigational Site
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Kasama, Ibaraki, Japan, 309-1793
- Pfizer Investigational Site
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Moriya, Ibaraki, Japan, 302-0118
- Pfizer Investigational Site
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Toride, Ibaraki, Japan, 302-0005
- Pfizer Investigational Site
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Tsuchiura, Ibaraki, Japan, 300-0053
- Pfizer Investigational Site
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Kanagawa
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Yokohama, Kanagawa, Japan, 232-0021
- Pfizer Investigational Site
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Kangawa
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Yokosuka, Kangawa, Japan, 239-0821
- Pfizer Investigational Site
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Miyagi
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Kami-gun, Miyagi, Japan, 981-4321
- Pfizer Investigational Site
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Nagasaki
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Shigesato-cho, Nagasaki, Nagasaki, Japan, 852-8511
- Pfizer Investigational Site
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Niigata
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Shindoori, Niigata-shi, Niigata, Japan, 950-2087
- Pfizer Investigational Site
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Osaka
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Katano, Osaka, Japan, 576-0016
- Pfizer Investigational Site
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Tokyo
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Akiruno, Tokyo, Japan, 190-0163
- Pfizer Investigational Site
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Chofu, Tokyo, Japan, 182-0006
- Pfizer Investigational Site
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Chofu, Tokyo, Japan, 182-0022
- Pfizer Investigational Site
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Kodaira, Tokyo, Japan, 187-0042
- Pfizer Investigational Site
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Nakano, Tokyo, Japan, 164-0012
- Pfizer Investigational Site
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Setagaya, Tokyo, Japan, 158-0095
- Pfizer Investigational Site
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Shinagawa, Tokyo, Japan, 140-0011
- Pfizer Investigational Site
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Yamagata
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Yonezawa, Yamagata, Japan, 992-0045
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 80 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The primary endpoint is investigator's clinical efficacy at Day 8.
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Secondary Outcome Measures
Outcome Measure |
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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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (ACTUAL)
June 1, 2007
Study Completion (ACTUAL)
June 1, 2007
Study Registration Dates
First Submitted
August 3, 2006
First Submitted That Met QC Criteria
August 3, 2006
First Posted (ESTIMATE)
August 4, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
April 21, 2011
Last Update Submitted That Met QC Criteria
April 20, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A0661175
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
Jiangxi Qingfeng Pharmaceutical Co. Ltd.UnknownAcute Exacerbation of Chronic BronchitisChina
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PharmaKingCompletedAcute Exacerbation of Chronic BronchitisKorea, Republic of
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AbbottCompletedAcute Bacterial Exacerbation of Chronic Bronchitis (ABECB).United States, Canada, Puerto Rico
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Northumbria Healthcare NHS Foundation TrustNewcastle-upon-Tyne Hospitals NHS Trust; National Institute for Health Research... and other collaboratorsCompletedPulmonary Disease, Chronic Obstructive | Emphysema | Chronic Bronchitis | Pulmonary Disease, Obstructive | Chronic Bronchitis With Airways Obstruction | Chronic Bronchitis With Acute ExacerbationUnited Kingdom
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Parc de Salut MarCompletedObstructive Chronic Bronchitis With Acute ExacerbationSpain
Clinical Trials on Azithromycin SR
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PfizerCompletedBacterial Infections
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PfizerCompletedTonsillitis | PharyngitisBelgium, India, Germany, United States, France, United Kingdom, Netherlands, Finland, Italy, Norway
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PfizerCompletedPneumonia, Community-AcquiredJapan
-
PfizerCompletedUpper Respiratory Tract InfectionJapan
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PfizerCompletedTonsillitisCanada, United States, Costa Rica, Guatemala, India
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PfizerCompletedChronic BronchitisTaiwan, China, Philippines, Singapore, Thailand, Malaysia
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PfizerCompletedPneumoniaUnited States, Canada, Russian Federation, India, Argentina, Estonia, Lithuania