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| Sponsor: | Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00656747 |
Purpose
A study to assess the safety and efficacy of moxifloxacin compared to that of amoxicillin-clavulanic acid for the treatment of subjects with acute exacerbation of chronic bronchitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Bronchitis |
Drug: Avelox (Moxifloxacin, BAY12-8039) Drug: Amoxicillin clavulanic acid |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | MAESTRAL - A Prospective, Multinational, Multicenter, Randomized, Double Blind, Double Dummy, Controlled Study Comparing the Efficacy and Safety of Moxifloxacin to That of Amoxicillin Clavulanic Acid for the Treatment of Subjects With Acute Exacerbations of Chronic Bronchitis. |
| Enrollment: | 1364 |
| Study Start Date: | March 2008 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Arm 2 |
Drug: Amoxicillin clavulanic acid
Subjects will be randomised to amoxicillin-clavulanic acid 875/125 mg PO BID (7 days). Subjects will also take placebo tablets, so that each subject takes 3 tablets per day for 7 days. Prior to randomization, subjects are stratified based on co-administration of short-course systemic steroids.
|
| Experimental: Arm 1 |
Drug: Avelox (Moxifloxacin, BAY12-8039)
Subjects will be randomised to moxifloxacin 400 mg PO OD (5 days). Subjects will also take placebo tablets, so that each subject takes 3 tablets per day for 7 days. Prior to randomization, subjects are stratified based on co-administration of short-course systemic steroids.
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Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All symptoms/signs must be present and confirmed by the Investigator:
Exclusion Criteria:
Contacts and Locations
Show 220 Study Locations| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Medical Affairs Therapeutic Area Head, Bayer HealthCare AG |
| ClinicalTrials.gov Identifier: | NCT00656747 History of Changes |
| Other Study ID Numbers: | 11980, EudraCT: 2007-006096-37 |
| Study First Received: | April 4, 2008 |
| Last Updated: | January 19, 2011 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Andorra: Ethics Committee; Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Federal Agency for Medicinal Products and Health Products; Brazil: National Health Surveillance Agency; Canada: Health Canada; Chile: Comisión Nacional de Investigación Científica y Tecnológica; China: State Food and Drug Administration; Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Croatia: Ministry of Health; Czech Republic: State Institute for Drug Control; Germany: Federal Institute for Drugs and Medical Devices; Greece: Ministry of Health and Welfare; Hong Kong: Department of Health; Indonesia: National Agency of Drug and Food Control; Ireland: Irish Medicines Board; Italy: Ethics Committee; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health; Mexico: Ministry of Health; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Pakistan: Ministry of Health; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; Philippines: Bureau of Food and Drugs; Portugal: National Pharmacy and Medicines Institute; South Africa: Department of Health; South Africa: Medicines Control Council; Spain: Ministry of Health; Spain: Spanish Agency of Medicines; Switzerland: Swissmedic; Thailand: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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Chronic Obstructive Pulmonary Disease (COPD) Acute exacerbation of COPD (AECOPD) chronic bronchitis bronchitis chest infection |
smoking lung disease lung lungs |
|
Bronchitis Acute Disease Bronchitis, Chronic Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections Disease Attributes Pathologic Processes Pulmonary Disease, Chronic Obstructive Amoxicillin Clavulanic Acids Clavulanic Acid Amoxicillin-Potassium Clavulanate Combination |
Moxifloxacin Norgestimate, ethinyl estradiol drug combination Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |