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| Sponsor: | Abbott |
|---|---|
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00645086 |
Purpose
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)
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 146 Study Locations
More Information
| 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 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Acute Disease Anti-Infective Agents Disease Attributes Molecular Mechanisms of Pharmacological Action Bronchial Diseases Enzyme Inhibitors Pharmacologic Actions Anti-Bacterial Agents Bronchitis, Chronic Clarithromycin |
Protein Synthesis Inhibitors Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Diseases Respiratory Tract Infections Therapeutic Uses Lung Diseases Bronchitis Pulmonary Disease, Chronic Obstructive |