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| Sponsor: | Abbott |
|---|---|
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00645086 |
Purpose
To compare the efficacy of a 5-day course of clarithromycin extended-release tablets (2 x 500 mg QD) with that of a 7-day course of clarithromycin immediate-release tablets (1 x 500 mg BID) in the treatment of acute bacterial exacerbation of chronic bronchitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB). |
Drug: clarithromycin extended-release tablets Drug: clarithromycin immediate-release tablets |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
| Official Title: | A Phase III Comparative Efficacy Study of 5 Days of M02-472 Clarithromycin Extended-Release Tablets to 7 Days of Clarithromycin Immediate-Release Tablets for the Treatment of Subjects With Acute Bacterial Exacerbation of Chronic Bronchitis. |
| Enrollment: | 465 |
| Study Start Date: | December 2002 |
| Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| A: Active Comparator |
Drug: clarithromycin extended-release tablets
5-day course of clarithromycin extended-release tablets (2 x 500 mg QD)
|
| B: Active Comparator |
Drug: clarithromycin immediate-release tablets
7-day course of clarithromycin immediate-release tablets (1 x 500 mg BID)
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Birmingham, Alabama, United States, 35242 | |
| Ozark, Alabama, United States, 36360 | |
| Hoover, Alabama, United States, 35216 | |
| Montgomery, Alabama, United States, 36106 | |
| Birmingham, Alabama, United States, 35235 | |
| Columbiana, Alabama, United States, 35051 | |
| Mobile, Alabama, United States, 36608 | |
| United States, Arizona | |
| Sun City West, Arizona, United States, 85375 | |
| Tucson, Arizona, United States, 85712 | |
| Glendale, Arizona, United States, 85306 | |
| Phoenix, Arizona, United States, 85006 | |
| Tucson, Arizona, United States, 85746 | |
| United States, Arkansas | |
| Camden, Arkansas, United States, 71701 | |
| United States, California | |
| Fresno, California, United States, 93703 | |
| Clovis, California, United States, 93611 | |
| Upland, California, United States, 91786 | |
| San Diego, California, United States, 92117 | |
| Lakewood, California, United States, 90712 | |
| San Jose, California, United States, 95128 | |
| Rancho Cucamonga, California, United States, 91730 | |
| Temecula, California, United States, 92591 | |
| Sylmar, California, United States, 91342 | |
| Roseville, California, United States, 95661 | |
| San Diego, California, United States, 92123 | |
| Torrance, California, United States, 90505 | |
| Pasadena, California, United States, 91105 | |
| Corona, California, United States, 92879 | |
| Fountain View, California, United States, 92708 | |
| San Diego, California, United States, 92103 | |
| Huntington Beach, California, United States, 92647 | |
| United States, Colorado | |
| Colorado Springs, Colorado, United States, 80909 | |
| Wheat Ridge, Colorado, United States, 80033 | |
| Loveland, Colorado, United States, 80538 | |
| United States, Connecticut | |
| Waterbury, Connecticut, United States, 06708 | |
| United States, Florida | |
| New Port Richey, Florida, United States, 34652 | |
| Orlando, Florida, United States, 32806 | |
| Miami, Florida, United States, 33186 | |
| Gainesville, Florida, United States, 32605 | |
| Brandon, Florida, United States, 33511 | |
| Tampa, Florida, United States, 33614 | |
| Panama City, Florida, United States, 32405 | |
| Largo, Florida, United States, 33770 | |
| Fort Lauderdale, Florida, United States, 33316 | |
| Miami, Florida, United States, 33157 | |
| Tallahassee, Florida, United States, 36078 | |
| Deland, Florida, United States, 32720 | |
| Merritt Island, Florida, United States, 32953 | |
| United States, Georgia | |
| Fort Gordon, Georgia, United States, 30905 | |
| Atlanta, Georgia, United States, 30342 | |
| Marietta, Georgia, United States, 30060 | |
| Blue Ridge, Georgia, United States, 30513 | |
| Rome, Georgia, United States, 30165-1698 | |
| United States, Idaho | |
| Coeur d'Alene, Idaho, United States, 83814 | |
| United States, Illinois | |
| Hines, Illinois, United States, 60141 | |
| Chicago, Illinois, United States, 60612 | |
| Orland Park, Illinois, United States, 60462 | |
| United States, Indiana | |
| Evansville, Indiana, United States, 47712 | |
| Indianapolis, Indiana, United States, 46254 | |
| Elkhart, Indiana, United States, 46514 | |
| United States, Kansas | |
| Wichita, Kansas, United States, 67207 | |
| United States, Kentucky | |
| Murray, Kentucky, United States, 42071 | |
| Lexington, Kentucky, United States, 40508 | |
| United States, Louisiana | |
| Baton Rouge, Louisiana, United States, 70816 | |
| New Orleans, Louisiana, United States, 70128 | |
| Metairie, Louisiana, United States, 70006 | |
| Sunset, Louisiana, United States, 70584 | |
| United States, Maine | |
| Auburn, Maine, United States, 04210 | |
| United States, Maryland | |
| Chester, Maryland, United States, 21619 | |
| United States, Michigan | |
| Dewitt, Michigan, United States, 48820 | |
| Livonia, Michigan, United States, 48152 | |
| St. Joseph, Michigan, United States, 49085 | |
| Saginaw, Michigan, United States, 48602 | |
| United States, Missouri | |
| Springfield, Missouri, United States, 65802 | |
| Jefferson City, Missouri, United States, 65109 | |
| St. Louis, Missouri, United States, 63110-1093 | |
| Chesterfield, Missouri, United States, 63017 | |
| United States, Montana | |
| Missoula, Montana, United States, 59804 | |
| United States, Nebraska | |
| Omaha, Nebraska, United States, 68134 | |
| United States, New Jersey | |
| West Caldwell, New Jersey, United States, 07007 | |
| Blackwood, New Jersey, United States, 08012 | |
| Toms River, New Jersey, United States, 08755 | |
| Mount Laurel, New Jersey, United States, 08054 | |
| United States, New York | |
| Camillus, New York, United States, 13031 | |
| Astoria, New York, United States, 11102 | |
| Bronxville, New York, United States, 10708 | |
| Buffalo, New York, United States, 14215 | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Winston-Salem, North Carolina, United States, 27103 | |
| Greensboro, North Carolina, United States, 27401 | |
| United States, Ohio | |
| Chardon, Ohio, United States, 44024 | |
| Toledo, Ohio, United States, 43617 | |
| Mogadore, Ohio, United States, 44260 | |
| Toledo, Ohio, United States, 43614 | |
| Zanesville, Ohio, United States, 43701 | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Oregon | |
| Lake Oswego, Oregon, United States, 97035 | |
| Eugene, Oregon, United States, 97404 | |
| Portland, Oregon, United States, 97219 | |
| Medford, Oregon, United States, 97504 | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19142 | |
| Fleetwood, Pennsylvania, United States, 19522 | |
| Philadelphia, Pennsylvania, United States, 19148 | |
| Bensalem, Pennsylvania, United States, 19020 | |
| Philadelphia, Pennsylvania, United States, 19138 | |
| Ridley Park, Pennsylvania, United States, 19078 | |
| United States, Rhode Island | |
| East Providence, Rhode Island, United States, 02914 | |
| Cranston, Rhode Island, United States, 02920 | |
| United States, South Carolina | |
| Simpsonville, South Carolina, United States, 29681 | |
| Spartanburg, South Carolina, United States, 29302 | |
| Greer, South Carolina, United States, 29651 | |
| Bamberg, South Carolina, United States, 29003 | |
| United States, Tennessee | |
| New Tazewell, Tennessee, United States, 37825 | |
| Johnson City, Tennessee, United States, 37601 | |
| Ducktown, Tennessee, United States, 37326 | |
| Clarksville, Tennessee, United States, 37043 | |
| Selmer, Tennessee, United States, 38375 | |
| Chattanooga, Tennessee, United States, 37404 | |
| Savannah, Tennessee, United States, 38372 | |
| United States, Texas | |
| San Antonio, Texas, United States, 78233 | |
| Austin, Texas, United States, 78728 | |
| San Angelo, Texas, United States, 76904 | |
| Beaumont, Texas, United States, 77701 | |
| El Paso, Texas, United States, 79925 | |
| Fort Worth, Texas, United States, 76135 | |
| Colleyville, Texas, United States, 76034 | |
| United States, Utah | |
| Salt Lake City, Utah, United States, 84102 | |
| United States, Virginia | |
| Richmond, Virginia, United States, 23226 | |
| Newport News, Virginia, United States, 23606 | |
| Mechanicsville, Virginia, United States, 23111 | |
| Christianburg, Virginia, United States, 24073 | |
| United States, Washington | |
| Spokane, Washington, United States, 99204 | |
| Spokane, Washington, United States, 99216 | |
| Spokane, Washington, United States, 99207 | |
| United States, Wisconsin | |
| New Berlin, Wisconsin, United States, 53151 | |
| Milwaukee, Wisconsin, United States, 53125 | |
| Canada, British Columbia | |
| Coquitlam, British Columbia, Canada, V3K 3P4 | |
| Canada, Manitoba | |
| Winnipeg, Manitoba, Canada, R3R 0C5 | |
| Canada, Ontario | |
| Scarborough, Ontario, Canada, M1B 4Z8 | |
| Mississauga, Ontario, Canada, L5M 2V8 | |
| Toronto, Ontario, Canada, M9W 4L6 | |
| Kitchener, Ontario, Canada, N2C 2N9 | |
| Markham, Ontario, Canada, L6B 1A1 | |
| Canada, Quebec | |
| Ste-Foy, Quebec, Canada, G1V 4G5 | |
| Sherbrooke, Quebec, Canada, J1J 2B8 | |
| Canada, Saskatchewan | |
| Saskatoon, Saskatchewan, Canada, S7H 5M3 | |
| Puerto Rico | |
| San Juan, Puerto Rico, 00921-3201 | |
More Information
| Responsible Party: | Abbott ( Angela M Nilius, Ph.D. ) |
| Study ID Numbers: | M02-472 |
| Study First Received: | March 24, 2008 |
| Last Updated: | March 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00645086 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Acute Disease Anti-Infective Agents Disease Attributes Molecular Mechanisms of Pharmacological Action Bronchial Diseases Enzyme Inhibitors Pharmacologic Actions Anti-Bacterial Agents Bronchitis, Chronic Clarithromycin |
Protein Synthesis Inhibitors Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Diseases Respiratory Tract Infections Therapeutic Uses Lung Diseases Bronchitis Pulmonary Disease, Chronic Obstructive |