![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsored by: |
Bayer |
---|---|
Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00656747 |
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 |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 1786 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm 2: Active Comparator |
Drug: Amoxicillin
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.
|
Arm 1: Experimental |
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.
|
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:
Contact: Bayer Clinical Trial Contact | clinical-trials-contact@bayerhealtcare.com |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer HealthCare AG ( Medical Affairs Therapeutic Area Head ) |
Study ID Numbers: | 11980, EudraCT: 2007-006096-37 |
Study First Received: | April 4, 2008 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00656747 |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; 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; France: Afssaps - French Health Products Safety Agency; 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; United States: Institutional Review Board |
Acute Exacerbation of Chronic Bronchitis (AECB), Chronic Bronchitis (CB), Chronic Obstructive Pulmonary Disease (COPD) |
Acute Disease Amoxicillin Clavulanic Acids Amoxicillin-Potassium Clavulanate Combination Bronchitis, Chronic Lung Diseases, Obstructive Respiratory Tract Diseases |
Respiratory Tract Infections Moxifloxacin Lung Diseases 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 |