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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00254566 |
This trial is a research drug study to compare the effects of two antibiotics for the treatment of acute exacerbation of chronic bronchitis
Condition | Intervention | Phase |
---|---|---|
Chronic Bronchitis |
Other: Placebo Drug: Moxifloxacin Drug: Azithromycin SR |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3B Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial To Evaluate The Efficacy and Safety Of Azithromycin SR (Microspheres Formulation) Versus Moxifloxacin For The Treatment Of Acute Exacerbation Of Chronic Bronchitis (AECB). |
Enrollment: | 398 |
Study Start Date: | February 2006 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
2: Experimental |
Drug: Moxifloxacin
1 X 400mg capsule once daily for 5 days
Other: Placebo
single dose, oral.
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1: Active Comparator |
Other: Placebo
1 capsule once daily for 5 days
Drug: Azithromycin SR
single dose 2.0 g oral
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A0661147 |
Study First Received: | November 14, 2005 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00254566 |
Health Authority: | Singapore: Health Sciences Authority |
Azithromycin SR; Moxifloxacin; Acute exacerbation of chronic bronchitis (AECB) |
Acute Disease Bronchitis, Chronic Lung Diseases, Obstructive Respiratory Tract Infections Respiratory Tract Diseases |
Moxifloxacin Azithromycin Lung Diseases Bronchitis Pulmonary Disease, Chronic Obstructive |
Anti-Infective Agents Anti-Bacterial Agents Disease Attributes Pathologic Processes |
Bronchial Diseases Therapeutic Uses Pharmacologic Actions |