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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 |
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 |
Hide Study Locations| Andorra | |
| Recruiting | |
| Escaldes - Engordany, Andorra | |
| Argentina, Buenos Aires | |
| Recruiting | |
| Vicente López, Buenos Aires, Argentina, B1602DOH | |
| Recruiting | |
| Quilmes, Buenos Aires, Argentina | |
| Argentina, Buenos aires | |
| Recruiting | |
| Florencio Varela, Buenos aires, Argentina | |
| Argentina, Capital Federal | |
| Recruiting | |
| Buenos Aires, Capital Federal, Argentina, C1425AWC | |
| Terminated | |
| Buenos Aires, Capital Federal, Argentina | |
| Recruiting | |
| Buenos Aires, Capital Federal, Argentina, 1426 | |
| Recruiting | |
| Buenos Aires, Capital Federal, Argentina | |
| Argentina, Tucumán | |
| Recruiting | |
| San Miguel de Tucumán, Tucumán, Argentina, 4000 | |
| Recruiting | |
| San Miguel de Tucumán, Tucumán, Argentina | |
| Australia, New South Wales | |
| Not yet recruiting | |
| Sydney, New South Wales, Australia, 2139 | |
| Australia, Queensland | |
| Recruiting | |
| Brisbane, Queensland, Australia, 4101 | |
| Australia, South Australia | |
| Recruiting | |
| Adelaide, South Australia, Australia, 5011 | |
| Recruiting | |
| Adelaide, South Australia, Australia, 5041 | |
| Australia, Western Australia | |
| Recruiting | |
| Perth, Western Australia, Australia, 6009 | |
| Belgium | |
| Not yet recruiting | |
| YVOIR, Belgium, 5530 | |
| Recruiting | |
| AALST, Belgium, 9300 | |
| Not yet recruiting | |
| ANTWERPEN, Belgium, 2018 | |
| Recruiting | |
| NAMUR, Belgium, 5000 | |
| Not yet recruiting | |
| BRUXELLES - BRUSSEL, Belgium, 1020 | |
| Brazil, mg | |
| Recruiting | |
| Juiz de Fora, mg, Brazil, 36036-110 | |
| Brazil, RS | |
| Recruiting | |
| Porto Alegre, RS, Brazil, 90610-000 | |
| Brazil, SP | |
| Not yet recruiting | |
| Sao Paulo, SP, Brazil, 05403-900 | |
| Recruiting | |
| Sao Paulo, SP, Brazil, 04023-900 | |
| Canada, Alberta | |
| Recruiting | |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Recruiting | |
| Calgary, Alberta, Canada, T2N 4N1 | |
| Recruiting | |
| Edmonton, Alberta, Canada, T6L 5X8 | |
| Canada, British Columbia | |
| Recruiting | |
| Kelowna, British Columbia, Canada, V1Y 9L8 | |
| Recruiting | |
| Vancouver, British Columbia, Canada, V5Z 4E1 | |
| Canada, Manitoba | |
| Recruiting | |
| Winnipeg, Manitoba, Canada, R3C 0N2 | |
| Terminated | |
| Winnipeg, Manitoba, Canada, R3A 1R9 | |
| Canada, New Brunswick | |
| Terminated | |
| St. John, New Brunswick, Canada, E2M 3W5 | |
| Not yet recruiting | |
| St. John, New Brunswick, Canada, E2K 2T8 | |
| Canada, Nova Scotia | |
| Recruiting | |
| Antigonish, Nova Scotia, Canada, B2G 2C2 | |
| Recruiting | |
| Sydney Mines, Nova Scotia, Canada, B1V 2Y5 | |
| Canada, Ontario | |
| Not yet recruiting | |
| London, Ontario, Canada, N6A 4V2 | |
| Not yet recruiting | |
| Hamilton, Ontario, Canada, L8N 4A6 | |
| Not yet recruiting | |
| Toronto, Ontario, Canada, M6H 3M2 | |
| Not yet recruiting | |
| London, Ontario, Canada, N6A 5R9 | |
| Not yet recruiting | |
| Burlington, Ontario, Canada, L7R 2H3 | |
| Canada, Quebec | |
| Recruiting | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Not yet recruiting | |
| Sherbrooke, Quebec, Canada, JIH 4J6 | |
| Terminated | |
| Longueuil, Quebec, Canada, J4N 1E1 | |
| Chile | |
| Recruiting | |
| Viña del Mar, Chile | |
| Recruiting | |
| Santiago, Chile | |
| Recruiting | |
| Valparaiso, Chile, 236-3058 | |
| Not yet recruiting | |
| Santiago, Chile | |
| Chile, V Region | |
| Not yet recruiting | |
| Viña del Mar, V Region, Chile | |
| China | |
| Recruiting | |
| Shanghai, China, 200233 | |
| Recruiting | |
| Shanghai, China, 200003 | |
| Recruiting | |
| Shanghai, China, 200040 | |
| Recruiting | |
| Tianjin, China, 300052 | |
| Recruiting | |
| beijing, China, 100020 | |
| Recruiting | |
| Beijing, China, 100050 | |
| China, Guangdong | |
| Recruiting | |
| Guangzhou, Guangdong, China, 510120 | |
| China, Liaoning | |
| Recruiting | |
| Shenyang, Liaoning, China, 11000 | |
| Recruiting | |
| Shenyang, Liaoning, China, 110003 | |
| China, Sichuan | |
| Recruiting | |
| Chengdu, Sichuan, China, 610041 | |
| Colombia | |
| Recruiting | |
| Bogotá, Colombia | |
| Not yet recruiting | |
| Bogotá, Colombia | |
| Not yet recruiting | |
| Medellín, Colombia | |
| Recruiting | |
| Cali, Colombia | |
| Not yet recruiting | |
| Bucaramanga, Colombia | |
| Recruiting | |
| Medellín, Colombia | |
| Colombia, Valle del Cauca | |
| Not yet recruiting | |
| Cali, Valle del Cauca, Colombia | |
| Croatia | |
| Not yet recruiting | |
| Zagreb, Croatia, 10000 | |
| Not yet recruiting | |
| Rijeka, Croatia, 510 00 | |
| Not yet recruiting | |
| Petrinja, Croatia, 44 250 | |
| Not yet recruiting | |
| Osijek, Croatia, 310 00 | |
| Czech Republic | |
| Not yet recruiting | |
| Praha - Malesice, Czech Republic, 108 00 | |
| Not yet recruiting | |
| Kyjov, Czech Republic, 697 01 | |
| Not yet recruiting | |
| Lovosice, Czech Republic, 410 02 | |
| Not yet recruiting | |
| Neratovice, Czech Republic, 227 11 | |
| Not yet recruiting | |
| Praha - Troja, Czech Republic, 182 00 | |
| Not yet recruiting | |
| Pardubice - Trnova, Czech Republic, 530 09 | |
| France | |
| Terminated | |
| PERPIGNAN, France, 66025 | |
| Terminated | |
| NICE, France, 06000 | |
| Terminated | |
| MARSEILLE, France, 13009 | |
| Terminated | |
| MONT-DE-MARSAN, France, 40000 | |
| Germany | |
| Recruiting | |
| Berlin, Germany, 10717 | |
| Terminated | |
| Berlin, Germany, 12043 | |
| Recruiting | |
| Berlin, Germany, 12203 | |
| Recruiting | |
| Berlin, Germany, 10969 | |
| Recruiting | |
| Hamburg, Germany, 20354 | |
| Not yet recruiting | |
| Berlin, Germany, 13597 | |
| Recruiting | |
| Berlin, Germany, 14059 | |
| Germany, Baden-Württemberg | |
| Recruiting | |
| Bad Dürrheim, Baden-Württemberg, Germany, 78073 | |
| Germany, Bayern | |
| Terminated | |
| Augsburg, Bayern, Germany, 86150 | |
| Germany, Brandenburg | |
| Not yet recruiting | |
| Rüdersdorf, Brandenburg, Germany, 15562 | |
| Recruiting | |
| Cottbus, Brandenburg, Germany, 03050 | |
| Recruiting | |
| Zossen, Brandenburg, Germany, 15806 | |
| Germany, Hessen | |
| Recruiting | |
| Fulda, Hessen, Germany, 36039 | |
| Terminated | |
| Frankfurt, Hessen, Germany, 60318 | |
| Germany, Mecklenburg-Vorpommern | |
| Terminated | |
| Neubrandenburg, Mecklenburg-Vorpommern, Germany, 17033 | |
| Germany, Nordrhein-Westfalen | |
| Recruiting | |
| Lüdenscheid, Nordrhein-Westfalen, Germany, 58515 | |
| Germany, Rheinland-Pfalz | |
| Not yet recruiting | |
| Neuwied, Rheinland-Pfalz, Germany, 56564 | |
| Germany, Sachsen | |
| Recruiting | |
| Leipzig, Sachsen, Germany, 04357 | |
| Not yet recruiting | |
| Dresden, Sachsen, Germany, 01307 | |
| Terminated | |
| Leipzig, Sachsen, Germany, 04275 | |
| Not yet recruiting | |
| Leipzig, Sachsen, Germany, 04207 | |
| Not yet recruiting | |
| Delitzsch, Sachsen, Germany, 04509 | |
| Germany, Schleswig-Holstein | |
| Recruiting | |
| Bad Segeberg, Schleswig-Holstein, Germany, 23795 | |
| Recruiting | |
| Lübeck, Schleswig-Holstein, Germany, 23552 | |
| Greece | |
| Recruiting | |
| Athens, Greece, 11527 | |
| Greece, Attica | |
| Recruiting | |
| Athens, Attica, Greece, 106 76 | |
| Greece, Ioannina | |
| Recruiting | |
| Dourouti-Ioannina, Ioannina, Greece, 45500 | |
| Greece, Larissa | |
| Recruiting | |
| Mezourlo, Larissa, Greece, 41110 | |
| Greece, Patras | |
| Recruiting | |
| Rio, Patras, Greece, 265 04 | |
| Hong Kong | |
| Recruiting | |
| New Territories, Hong Kong | |
| Recruiting | |
| Kowloon, Hong Kong | |
| Indonesia | |
| Recruiting | |
| Jakarta, Indonesia | |
| Recruiting | |
| Bandung, Indonesia | |
| Recruiting | |
| Surabaya, Indonesia | |
| Ireland, Co Kerry | |
| Not yet recruiting | |
| Killarney, Co Kerry, Ireland | |
| Ireland, Co Longford | |
| Not yet recruiting | |
| Longford, Co Longford, Ireland | |
| Ireland, Co Wexford | |
| Terminated | |
| Gorey, Co Wexford, Ireland | |
| Recruiting | |
| Enniscorthy, Co Wexford, Ireland | |
| Not yet recruiting | |
| Gorey, Co Wexford, Ireland | |
| Ireland, Dublin | |
| Not yet recruiting | |
| Rathmines, Dublin, Ireland | |
| Ireland, Wicklow | |
| Not yet recruiting | |
| Bray, Wicklow, Ireland | |
| Italy | |
| Recruiting | |
| Chieti, Italy, 66100 | |
| Not yet recruiting | |
| Milano, Italy, 20157 | |
| Recruiting | |
| Ancona, Italy, 60100 | |
| Terminated | |
| Perugia, Italy, 06156 | |
| Not yet recruiting | |
| Catania, Italy, 95123 | |
| Italy, Salerno | |
| Recruiting | |
| Nocera Inferiore, Salerno, Italy, 84014 | |
| Italy, Varese | |
| Recruiting | |
| Busto Arsizio, Varese, Italy, 21052 | |
| Italy, Verona | |
| Not yet recruiting | |
| Bussolengo, Verona, Italy, 37012 | |
| Latvia | |
| Not yet recruiting | |
| Riga, Latvia, 1011 | |
| Terminated | |
| Riga, Latvia, 1009 | |
| Not yet recruiting | |
| Valmiera, Latvia, 4201 | |
| Recruiting | |
| Ventspils, Latvia | |
| Lithuania | |
| Not yet recruiting | |
| Vilnius, Lithuania, LT-07156 | |
| Recruiting | |
| Vilnius, Lithuania, LT-06122 | |
| Recruiting | |
| Kaunas, Lithuania, LT-50425 | |
| Recruiting | |
| Kaunas, Lithuania | |
| Recruiting | |
| Klaipeda, Lithuania, LT-94231 | |
| Not yet recruiting | |
| Siauliai, Lithuania, 76231 | |
| Mexico | |
| Not yet recruiting | |
| Chihuahua, Mexico, 31350 | |
| Not yet recruiting | |
| Zacatecas, Mexico, 98608 | |
| Mexico, Edo. de Mexico | |
| Not yet recruiting | |
| Huixquilucan, Edo. de Mexico, Mexico, CP 52763 | |
| Mexico, Jalisco | |
| Recruiting | |
| Guadalajara, Jalisco, Mexico, 44280 | |
| Mexico, Nuevo León | |
| Not yet recruiting | |
| Monterrey, Nuevo León, Mexico, 66480 | |
| Not yet recruiting | |
| Monterrey, Nuevo León, Mexico, 64718 | |
| Mexico, Yucatán | |
| Not yet recruiting | |
| Mérida, Yucatán, Mexico, 97001 | |
| Recruiting | |
| Mérida, Yucatán, Mexico, 97001 | |
| Netherlands | |
| Recruiting | |
| HEERLEN, Netherlands, 6419 PC | |
| Not yet recruiting | |
| HOOFDDORP, Netherlands, 2134 TM | |
| Not yet recruiting | |
| MEPPEL, Netherlands, 7943 KA | |
| Not yet recruiting | |
| UTRECHT, Netherlands, 3582 KE | |
| Netherlands, Noord Brabant | |
| Recruiting | |
| EINDHOVEN, Noord Brabant, Netherlands, 5623 EJ | |
| Pakistan | |
| Recruiting | |
| Karachi, Pakistan, 75500 | |
| Terminated | |
| Islamabad, Pakistan | |
| Pakistan, Sindh | |
| Terminated | |
| Karachi, Sindh, Pakistan, 74800 | |
| Peru | |
| Recruiting | |
| Lima, Peru, 33 | |
| Not yet recruiting | |
| Callao, Peru, CALLAO 2 | |
| Recruiting | |
| Lima, Peru | |
| Recruiting | |
| Lima, Peru, LIMA 27 | |
| Not yet recruiting | |
| Lima, Peru, 31 | |
| Not yet recruiting | |
| Lima, Peru, LIMA 18 | |
| Philippines | |
| Recruiting | |
| Manila, Philippines, 1000 | |
| Recruiting | |
| Quezon City, Philippines | |
| Portugal | |
| Terminated | |
| Lisboa, Portugal, 1649-035 | |
| Not yet recruiting | |
| Vila Nova de Gaia, Portugal, 4434-506 | |
| Not yet recruiting | |
| Lisboa, Portugal, 1169-024 | |
| Terminated | |
| Coimbra, Portugal, 3000-075 | |
| Not yet recruiting | |
| Santarém, Portugal, 2005-177 | |
| Not yet recruiting | |
| Torres Vedras, Portugal, 2560-324 | |
| Portugal, Coimbra | |
| Not yet recruiting | |
| S. Martinho do Bispo, Coimbra, Portugal, 3041-856 | |
| South Africa, Free State | |
| Recruiting | |
| Bloemfontein, Free State, South Africa, 9324 | |
| South Africa, Gauteng | |
| Recruiting | |
| Benoni, Gauteng, South Africa, 1500 | |
| Recruiting | |
| Kempton Park, Gauteng, South Africa, 1610 | |
| Recruiting | |
| Centurion, Gauteng, South Africa, 0140 | |
| Recruiting | |
| Pretoria, Gauteng, South Africa | |
| South Africa, KwaZulu Natal | |
| Recruiting | |
| Durban, KwaZulu Natal, South Africa, 4091 | |
| Not yet recruiting | |
| Durban, KwaZulu Natal, South Africa, 4037 | |
| South Africa, Limpopo | |
| Not yet recruiting | |
| Thabazimbi, Limpopo, South Africa, 0380 | |
| South Africa, Mpumalanga | |
| Recruiting | |
| Witbank, Mpumalanga, South Africa, 1035 | |
| South Africa, Port Elizabert | |
| Not yet recruiting | |
| Korsten, Port Elizabert, South Africa, 6014 | |
| South Africa, Pretoria | |
| Recruiting | |
| Eloffsdal, Pretoria, South Africa, 0084 | |
| Not yet recruiting | |
| Sunnyside, Pretoria, South Africa, 0002 | |
| South Africa, Western Cape | |
| Recruiting | |
| Paarl, Western Cape, South Africa, 7647 | |
| Recruiting | |
| Cape Town, Western Cape, South Africa, 7505 | |
| Recruiting | |
| Somerset West, Western Cape, South Africa, 7130 | |
| Spain | |
| Not yet recruiting | |
| Barcelona, Spain, 08034 | |
| Not yet recruiting | |
| Barcelona, Spain, 08036 | |
| Terminated | |
| Guadalajara, Spain, 19002 | |
| Not yet recruiting | |
| Madrid, Spain, 28040 | |
| Recruiting | |
| Palma de Mallorca, Spain, 07014 | |
| Spain, Barcelona | |
| Recruiting | |
| Badalona, Barcelona, Spain, 08916 | |
| Not yet recruiting | |
| Sant Boi de Llobregat, Barcelona, Spain, 08830 | |
| Spain, Valencia | |
| Recruiting | |
| Requena, Valencia, Spain, 46340 | |
| Switzerland | |
| Not yet recruiting | |
| Wettingen, Switzerland, 5430 | |
| Not yet recruiting | |
| Thun, Switzerland, 3600 | |
| Recruiting | |
| Basel, Switzerland, 4031 | |
| Not yet recruiting | |
| Zürich, Switzerland, 8048 | |
| Not yet recruiting | |
| Zürich, Switzerland, 8091 | |
| Switzerland, Aargau | |
| Not yet recruiting | |
| Aarau, Aargau, Switzerland, 5000 | |
| Switzerland, Basel-Land | |
| Terminated | |
| Oberwil, Basel-Land, Switzerland, 4104 | |
| Switzerland, Basel-Landschaft | |
| Terminated | |
| Laufen, Basel-Landschaft, Switzerland, 4242 | |
| Switzerland, Basel-Stadt | |
| Terminated | |
| Binningen, Basel-Stadt, Switzerland, 4102 | |
| Thailand | |
| Recruiting | |
| Bangkok, Thailand, 10330 | |
| Recruiting | |
| Chiangmai, Thailand, 50200 | |
| Recruiting | |
| Nonthaburi, Thailand, 11000 | |
| United Kingdom, Strathclyde | |
| Recruiting | |
| Glasgow, Strathclyde, United Kingdom, G69 7AD | |
| Terminated | |
| Glasgow, Strathclyde, United Kingdom, G3 8YJ | |
| Terminated | |
| Glasgow, Strathclyde, United Kingdom | |
| Recruiting | |
| Glasgow, Strathclyde, United Kingdom, G46 8NY | |
| Not yet recruiting | |
| Glasgow, Strathclyde, United Kingdom, G45 9AW | |
| United Kingdom, Warwickshire | |
| Terminated | |
| Coventry, Warwickshire, United Kingdom, CV7 8LA | |
| 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 |