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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00649831 |
This study compared the clinical efficacy and safety of azithromycin with that of amoxicillin-clavulanic acid, in patients between the ages of 35 and 75 years, presenting with an exacerbation of chronic bronchitis.
Condition | Intervention | Phase |
---|---|---|
Bronchitis, Chronic |
Drug: Amoxicillin/clavulinic acid Drug: Azithromycin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Azithromycin (Zithromax®) 5 Days Versus Amoxicillin-Clavulanic Acid (Augmentin®): Multicentre, Randomised, Open-Label Study To Compare The Clinical Efficacy And Safety Of Azithromycin With Those Of Amoxicillin-Clavulanic Acid In Patients Presenting With An Exacerbation Of Chronic Bronchitis |
Estimated Enrollment: | 250 |
Study Start Date: | October 2002 |
Study Completion Date: | June 2003 |
Arms | Assigned Interventions |
---|---|
Group 2: Active Comparator |
Drug: Amoxicillin/clavulinic acid
amoxicillin/clavulinic acid 500 mg/62.5 mg tablet; take 2 tablets by mouth twice daily (BID) for 10 days
|
Group 1: Active Comparator |
Drug: Azithromycin
Azithromycin 250 mg tablet; take 2 tablets by mouth on the first day, then 1 tablet by mouth from Days 2 to 5
|
Ages Eligible for Study: | 36 Years to 74 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
France | |
Pfizer Investigational Site | |
PARIS, France, 75020 | |
Pfizer Investigational Site | |
MAUBEUGE, France, 59600 | |
Pfizer Investigational Site | |
VILLEJUIF, France, 94800 | |
Pfizer Investigational Site | |
MANTES LA JOLIE, France, 78200 | |
Pfizer Investigational Site | |
TOURCOING, France, 59200 | |
Pfizer Investigational Site | |
WATTRELOS, France, 59150 | |
Pfizer Investigational Site | |
MONT SAINT MARTIN, France, 54350 | |
Pfizer Investigational Site | |
NANCY, France, 54000 | |
Pfizer Investigational Site | |
VINCENNES, France, 94300 | |
Pfizer Investigational Site | |
VALENTON, France, 94460 | |
Pfizer Investigational Site | |
LYON, France, 69001 | |
Pfizer Investigational Site | |
Paris, France, 75 016 | |
Pfizer Investigational Site | |
LES LILAS, France, 93 260 | |
Pfizer Investigational Site | |
SOISSONS, France, 02 200 | |
Pfizer Investigational Site | |
TULETTE, France, 26 790 | |
Pfizer Investigational Site | |
ANZIN, France, 59410 | |
Pfizer Investigational Site | |
MAROMME, France, 76150 | |
Pfizer Investigational Site | |
LE GRAND QUEVILLY, France, 76120 | |
Pfizer Investigational Site | |
ESCAUDAIN, France, 59 124 | |
Pfizer Investigational Site | |
VITRY, France, 94 400 | |
Pfizer Investigational Site | |
MARSEILLE, France, 13 008 | |
Pfizer Investigational Site | |
AVIGNON, France, 84 000 | |
Pfizer Investigational Site | |
SAINT AULAIRE, France, 19 130 | |
Pfizer Investigational Site | |
SAVIGNY, France, 91600 | |
Pfizer Investigational Site | |
VAUX S/ SEINE, France, 78740 | |
Pfizer Investigational Site | |
DIJON, France, 21000 | |
Pfizer Investigational Site | |
YERRES, France, 91330 | |
Pfizer Investigational Site | |
AVIGNON, France, 84000 | |
Pfizer Investigational Site | |
PARIS, France, 75017 | |
Pfizer Investigational Site | |
EQUEURDREVILLE HAINNEVILLE, France, 50120 | |
Pfizer Investigational Site | |
PARIS, France, 75012 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A0661045 |
Study First Received: | March 27, 2008 |
Last Updated: | October 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00649831 |
Health Authority: | Unknown: |
Acute Disease Amoxicillin Clavulanic Acids Amoxicillin-Potassium Clavulanate Combination Bronchitis, Chronic Lung Diseases, Obstructive Respiratory Tract Diseases |
Respiratory Tract Infections Lung Diseases Azithromycin Clavulanic Acid Bronchitis Pulmonary Disease, Chronic Obstructive |
Anti-Infective Agents Anti-Bacterial Agents Disease Attributes Pathologic Processes Molecular Mechanisms of Pharmacological Action |
Bronchial Diseases Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions |