A Trial Of Azithromycin SR For The Treatment Of Acute Bronchitis And Secondary Infection Of Chronic Respiratory Diseases
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| ClinicalTrials.gov Identifier: NCT00360464 |
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Recruitment Status :
Completed
First Posted : August 4, 2006
Last Update Posted : April 21, 2011
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Sponsor:
Pfizer
Information provided by:
Pfizer
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Bronchitis | Drug: Azithromycin SR | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 64 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | October 2006 |
| Actual Primary Completion Date : | June 2007 |
| Actual Study Completion Date : | June 2007 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Acute Bronchitis
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 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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| Ages Eligible for Study: | 16 Years to 80 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00360464
Locations
| Japan | |
| Pfizer Investigational Site | |
| Hitachinaka, Ibaraki, Japan, 312-0057 | |
| Pfizer Investigational Site | |
| Kasama, Ibaraki, Japan, 309-1793 | |
| Pfizer Investigational Site | |
| Moriya, Ibaraki, Japan, 302-0118 | |
| Pfizer Investigational Site | |
| Toride, Ibaraki, Japan, 302-0005 | |
| Pfizer Investigational Site | |
| Tsuchiura, Ibaraki, Japan, 300-0053 | |
| Pfizer Investigational Site | |
| Yokohama, Kanagawa, Japan, 232-0021 | |
| Pfizer Investigational Site | |
| Yokosuka, Kangawa, Japan, 239-0821 | |
| Pfizer Investigational Site | |
| Kami-gun, Miyagi, Japan, 981-4321 | |
| Pfizer Investigational Site | |
| Shigesato-cho, Nagasaki, Nagasaki, Japan, 852-8511 | |
| Pfizer Investigational Site | |
| Shindoori, Niigata-shi, Niigata, Japan, 950-2087 | |
| Pfizer Investigational Site | |
| Katano, Osaka, Japan, 576-0016 | |
| Pfizer Investigational Site | |
| Akiruno, Tokyo, Japan, 190-0163 | |
| Pfizer Investigational Site | |
| Chofu, Tokyo, Japan, 182-0006 | |
| Pfizer Investigational Site | |
| Chofu, Tokyo, Japan, 182-0022 | |
| Pfizer Investigational Site | |
| Kodaira, Tokyo, Japan, 187-0042 | |
| Pfizer Investigational Site | |
| Nakano, Tokyo, Japan, 164-0012 | |
| Pfizer Investigational Site | |
| Setagaya, Tokyo, Japan, 158-0095 | |
| Pfizer Investigational Site | |
| Shinagawa, Tokyo, Japan, 140-0011 | |
| Pfizer Investigational Site | |
| Yonezawa, Yamagata, Japan, 992-0045 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00360464 |
| Other Study ID Numbers: |
A0661175 |
| First Posted: | August 4, 2006 Key Record Dates |
| Last Update Posted: | April 21, 2011 |
| Last Verified: | April 2011 |
Additional relevant MeSH terms:
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Bronchitis Coinfection Respiration Disorders Respiratory Tract Diseases Acute Disease Infections Respiratory Tract Infections Bronchial Diseases |
Lung Diseases, Obstructive Lung Diseases Disease Attributes Pathologic Processes Azithromycin Anti-Bacterial Agents Anti-Infective Agents |