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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00645086 |
To compare the efficacy of a 5-day course of clarithromycin extended-release tablets (2 x 500 mg QD) with that of a 7-day course of clarithromycin immediate-release tablets (1 x 500 mg BID) in the treatment of acute bacterial exacerbation of chronic bronchitis.
Condition | Intervention | Phase |
---|---|---|
Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB). |
Drug: clarithromycin extended-release tablets Drug: clarithromycin immediate-release tablets |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
Official Title: | A Phase III Comparative Efficacy Study of 5 Days of M02-472 Clarithromycin Extended-Release Tablets to 7 Days of Clarithromycin Immediate-Release Tablets for the Treatment of Subjects With Acute Bacterial Exacerbation of Chronic Bronchitis. |
Enrollment: | 465 |
Study Start Date: | December 2002 |
Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator |
Drug: clarithromycin extended-release tablets
5-day course of clarithromycin extended-release tablets (2 x 500 mg QD)
|
B: Active Comparator |
Drug: clarithromycin immediate-release tablets
7-day course of clarithromycin immediate-release tablets (1 x 500 mg BID)
|
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Abbott ( Angela M Nilius, Ph.D. ) |
Study ID Numbers: | M02-472 |
Study First Received: | March 24, 2008 |
Last Updated: | March 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00645086 |
Health Authority: | United States: Food and Drug Administration |
Clarithromycin Bronchitis, Chronic Lung Diseases, Obstructive Respiratory Tract Infections |
Respiratory Tract Diseases Lung Diseases Bronchitis Pulmonary Disease, Chronic Obstructive |
Anti-Infective Agents Anti-Bacterial Agents Protein Synthesis Inhibitors Molecular Mechanisms of Pharmacological Action |
Bronchial Diseases Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions |