Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis
NCT ID: NCT00644553
Last Updated: 2008-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
437 participants
INTERVENTIONAL
2003-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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A
Clarithromycin
Clarithromycin Extended-Release 500 mg tablet (2 tablets QD)
B
Amoxicillin
Amoxicillin-clavulanate 875/125 mg tablet (1 tablet BID)
Interventions
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Clarithromycin
Clarithromycin Extended-Release 500 mg tablet (2 tablets QD)
Amoxicillin
Amoxicillin-clavulanate 875/125 mg tablet (1 tablet BID)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject must have a diagnosis of ABS. The diagnosis must be based on the following:
* A sinus radiograph (Water's view) or CT scan with evidence of maxillary opacification or
* Air/fluid levels purulent discharge from the nose
* At least two of the following additional signs and symptoms lasting longer than seven days prior to and no longer than 28 days before Evaluation 1.
* A pre-treatment sample from a sinus puncture or
* Middle meatus endoscopy must be obtained for bacterial aerobic culture
* Susceptibility testing (applicable only for selected investigative sites).
* Subject must be a suitable candidate for oral antibiotic therapy and able to swallow tablets intact.
Exclusion Criteria
* History of amoxicillin-clavulanate associated cholestatic jaundicehepatic dysfunction.
* Females who are pregnant or lactating.
* Subject has either of the following:
* Chronic sinusitis (signs and symptoms lasting longer than 28 days immediately prior to Evaluation 1)
* Significant anatomical abnormalities of the sinuses any other infection or
* Condition which necessitates use of a concomitant systemic antibiotic.
* Evidence of uncontrolled clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological, psychiatric or endocrine disease, malignancy, or other abnormality (other than the disease being studied).
* Any underlying condition/disease, that would be likely to interfere with the completion of the course of study drug therapy or follow-up.
* Known significant renal or hepatic impairment (or disease).
* Subject who has taken: a systemic antibiotic within 2 weeks before study drug administration or a long-acting injectable antibiotic (e.g., penicillin G benzathine) within 4 weeks before study drug administration.
* Immunocompromised subjects (e.g., neutropenic subjects).
* Subjects with known HIV infection.
* Treatment with any other investigational drug within 4 weeks prior to study drug administration.
12 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Locations
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Birmingham, Alabama, United States
Phoenix, Arizona, United States
Clovis, California, United States
La Jolla, California, United States
San Luis Obispo, California, United States
Coeur d'Alene, Idaho, United States
Charlotte, North Carolina, United States
Columbus, Ohio, United States
Eugene, Oregon, United States
Johnson City, Tennessee, United States
San Antonio, Texas, United States
Spokane, Washington, United States
Kitchener, Ontario, Canada
Toronto, Ontario, Canada
Sherbrooke, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Athens, , Greece
Athens, , Greece
Pátrai, , Greece
Piraeus, , Greece
Thessaloniki, , Greece
Thessaloniki, , Greece
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Salgótarján, , Hungary
Szombathely, , Hungary
Veszprém, , Hungary
Catania, , Italy
Genova, , Italy
Padua, , Italy
Palermo, , Italy
Pavia, , Italy
Kaunas, , Lithuania
Vilnius, , Lithuania
Vilnius, , Lithuania
Vilnius, , Lithuania
Bialystok, , Poland
Bielsko-Biala, , Poland
Bydgoszcz, , Poland
Gliwice, , Poland
Jelenia Góra, , Poland
Lublin, , Poland
Wroclaw, , Poland
Wroclaw, , Poland
Bucharest, , Romania
Bucharest, , Romania
Badajoz, , Spain
Barcelona, , Spain
Madrid, , Spain
Palma de Mallorca, , Spain
Valladolid, , Spain
Countries
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Other Identifiers
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M02-524
Identifier Type: -
Identifier Source: org_study_id