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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00644553 |
To compare the safety/tolerability and efficacy of a 14-day course of clarithromycin extended-release tablets (2 x 500 mg QD) with that of a 14-day course of amoxicillin-clavulanate tablets (875/125 mg BID) for the treatment of ambulatory subjects with Acute Bacterial Sinusitis (ABS).
Condition | Intervention | Phase |
---|---|---|
Acute Bacterial Sinusitis (ABS) |
Drug: Clarithromycin Drug: Amoxicillin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Parallel Assignment |
Official Title: | A Phase IIIB/IV Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets vs. Amoxicillin-Clavulanate for the Treatment of Subjects With Acute Bacterial Sinusitis |
Enrollment: | 437 |
Study Start Date: | May 2003 |
Primary Completion Date: | March 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator |
Drug: Clarithromycin
Clarithromycin Extended-Release 500 mg tablet (2 tablets QD)
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B: Active Comparator |
Drug: Amoxicillin
Amoxicillin-clavulanate 875/125 mg tablet (1 tablet BID)
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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subject must have a diagnosis of ABS. The diagnosis must be based on the following:
Exclusion Criteria:
Subject has either of the following:
Responsible Party: | Abbott ( Angela M Nilius, PhD ) |
Study ID Numbers: | M02-524 |
Study First Received: | March 22, 2008 |
Last Updated: | March 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00644553 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anti-Infective Agents Anti-Bacterial Agents Clarithromycin Amoxicillin Otorhinolaryngologic Diseases Respiratory Tract Infections |
Respiratory Tract Diseases Clavulanic Acid Clavulanic Acids Sinusitis Amoxicillin-Potassium Clavulanate Combination |
Anti-Infective Agents Amoxicillin Otorhinolaryngologic Diseases Molecular Mechanisms of Pharmacological Action Paranasal Sinus Diseases Clavulanic Acids Enzyme Inhibitors Sinusitis Amoxicillin-Potassium Clavulanate Combination |
Pharmacologic Actions Nose Diseases Protein Synthesis Inhibitors Clarithromycin Anti-Bacterial Agents Respiratory Tract Diseases Respiratory Tract Infections Therapeutic Uses Clavulanic Acid |