|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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 |
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: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (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.
|
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| Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com |
Show 210 Study Locations| Study Director: | Bayer Study Director | Bayer |
More Information
| 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: | September 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00656747 History of Changes |
| 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; Czech Republic: State Institute for Drug Control; 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 |
|
Acute Exacerbation of Chronic Bronchitis (AECB), Chronic Bronchitis (CB), Chronic Obstructive Pulmonary Disease (COPD) |
|
Acute Disease Anti-Infective Agents Disease Attributes Amoxicillin Molecular Mechanisms of Pharmacological Action Bronchial Diseases Clavulanic Acids Enzyme Inhibitors Amoxicillin-Potassium Clavulanate Combination Pharmacologic Actions Anti-Bacterial Agents |
Bronchitis, Chronic Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Diseases Respiratory Tract Infections Moxifloxacin Therapeutic Uses Clavulanic Acid Lung Diseases Bronchitis Pulmonary Disease, Chronic Obstructive |