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| Sponsor: | Abbott |
|---|---|
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00644553 |
Purpose
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: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| 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 |
|---|---|
| Active Comparator: A |
Drug: Clarithromycin
Clarithromycin Extended-Release 500 mg tablet (2 tablets QD)
Other Names:
|
| Active Comparator: B |
Drug: Amoxicillin
Amoxicillin-clavulanate 875/125 mg tablet (1 tablet BID)
Other Name: amoxicillin-clavulanate
|
Eligibility| 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:
Contacts and Locations
Show 53 Study Locations
More Information
| Responsible Party: | Angela M Nilius, PhD, Abbott |
| ClinicalTrials.gov Identifier: | NCT00644553 History of Changes |
| Other Study ID Numbers: | M02-524 |
| Study First Received: | March 22, 2008 |
| Last Updated: | March 26, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
Sinusitis Paranasal Sinus Diseases Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Amoxicillin Amoxicillin-Potassium Clavulanate Combination Clarithromycin |
Clavulanic Acids Clavulanic Acid Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protein Synthesis Inhibitors |