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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: | 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 |
|---|---|
| A: Active Comparator |
Drug: Clarithromycin
Clarithromycin Extended-Release 500 mg tablet (2 tablets QD)
|
| B: Active Comparator |
Drug: Amoxicillin
Amoxicillin-clavulanate 875/125 mg tablet (1 tablet BID)
|
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
Hide Study Locations| United States, Alabama | |
| Birmingham, Alabama, United States, 35235 | |
| United States, Arizona | |
| Phoenix, Arizona, United States, 85014 | |
| United States, California | |
| La Jolla, California, United States, 92037 | |
| San Luis Obispo, California, United States, 93405 | |
| Clovis, California, United States, 93611 | |
| United States, Idaho | |
| Coeur d'Alene, Idaho, United States, 83814 | |
| United States, North Carolina | |
| Charlotte, North Carolina, United States, 28210 | |
| United States, Ohio | |
| Columbus, Ohio, United States, 43235 | |
| United States, Oregon | |
| Eugene, Oregon, United States, 97404 | |
| United States, Tennessee | |
| Johnson City, Tennessee, United States, 37601 | |
| United States, Texas | |
| San Antonio, Texas, United States, 78209 | |
| United States, Washington | |
| Spokane, Washington, United States, 99216 | |
| Canada, Ontario | |
| Toronto, Ontario, Canada, M9W 4L6 | |
| Kitchener, Ontario, Canada, N2C 2N9 | |
| Canada, Quebec | |
| Sherbrooke, Quebec, Canada, J1J 2B8 | |
| Canada, Saskatchewan | |
| Saskatoon, Saskatchewan, Canada, S7H 0W6 | |
| Greece | |
| Thessaloniki, Greece, 56430 | |
| Athens, Greece, 115 27 | |
| Athens, Greece, 11522 | |
| Patra, Greece, 26500 | |
| Piraeus, Greece, 18454 | |
| Thessaloniki, Greece, 54636 | |
| Hungary | |
| Veszprem, Hungary, H-8200 | |
| Salgotarjan, Hungary, H-3100 | |
| Szombathely, Hungary, H-9700 | |
| Budapest, Hungary, H-1096 | |
| Budapest, Hungary, H-1062 | |
| Budapest, Hungary, H-1097 | |
| Budapest, Hungary, H-1106 | |
| Italy | |
| Palermo, Italy, 90127 | |
| Catania, Italy, 95124 | |
| Genova, Italy, 16132 | |
| Pavia, Italy, 27100 | |
| Padova, Italy, 35128 | |
| Lithuania | |
| Vilnius, Lithuania, LT-2021 | |
| Vilnius, Lithuania, LT-2014 | |
| Kaunas, Lithuania, LT-3007 | |
| Vilnius, Lithuania, LT-2025 | |
| Poland | |
| Bydgoszcz, Poland, 85-090 | |
| Bialystok, Poland, 15-276 | |
| Lublin, Poland, 20-954 | |
| Gliwice, Poland, 44-100 | |
| Jelenia Gora, Poland, 58-506 | |
| Wroclaw, Poland, 51-124 | |
| Wroclaw, Poland, 50-368 | |
| Bielsko-Biala, Poland, 43-300 | |
| Romania | |
| Bucharest, Romania, 762631 | |
| Bucharest, Romania, 773511 | |
| Spain | |
| Barcelona, Spain, 08036 | |
| Madrid, Spain, 28805 | |
| Valladolid, Spain, 47002 | |
| Badajoz, Spain, 06010 | |
| Palma de Mallorca, Spain, 07014 | |
More Information
| 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 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 |