A Trial Of Azithromycin SR For The Treatment Of Acute Bronchitis And Secondary Infection Of Chronic Respiratory Diseases
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00360464
First received: August 3, 2006
Last updated: April 20, 2011
Last verified: April 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Acute Bronchitis |
Drug: Azithromycin SR |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
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.
| Enrollment: | 64 |
| Study Start Date: | October 2006 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 16 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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, 182-0022 | |
| Pfizer Investigational Site | |
| Chofu, Tokyo, Japan, 182-0006 | |
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00360464 History of Changes |
| Other Study ID Numbers: | A0661175 |
| Study First Received: | August 3, 2006 |
| Last Updated: | April 20, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Bronchitis Acute Disease Respiration Disorders Respiratory Tract Diseases Bronchial Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections |
Disease Attributes Pathologic Processes Azithromycin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013