Comparative Study of 5 Days of M02-472 Clarithromycin Extended-Release Tablets to 7 Days of Clarithromycin Immediate-Release Tablets for the Treatment of Exacerbation of Chronic Bronchitis
NCT ID: NCT00645086
Last Updated: 2008-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
465 participants
INTERVENTIONAL
2002-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
clarithromycin extended-release tablets
5-day course of clarithromycin extended-release tablets (2 x 500 mg QD)
B
clarithromycin immediate-release tablets
7-day course of clarithromycin immediate-release tablets (1 x 500 mg BID)
Interventions
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clarithromycin extended-release tablets
5-day course of clarithromycin extended-release tablets (2 x 500 mg QD)
clarithromycin immediate-release tablets
7-day course of clarithromycin immediate-release tablets (1 x 500 mg BID)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject who has a medical history of chronic bronchitis.
* A history of regular medication use (\>=3 consecutive months within the past 2 years) to treat pulmonary disease.
* Subject must have evidence of pulmonary function test abnormalities.
* The onset of signs and symptoms of the current exacerbation must occur within 14 days before Evaluation 1.
Exclusion Criteria
* A female who is pregnant or is lactating.
* Subject who has suspected or known (positive chest radiograph) pneumonia.
* Subject who has evidence of significant bronchiectasis (by CT) or atelectasis, active tuberculosis or other mycobacterial infection, bullous emphysema, pulmonary embolism, lung abscess, tumor (primary or metastatic) involving the lung, pleural effusion, or cystic fibrosis that could confound the assessment of signs and symptoms of ABECB.
* Subject who requires parenteral antibiotic therapy.
* Subject who requires hospitalization for treatment of current episode of ABECB.
* Subject who has any other infection or condition, which necessitates use of a concomitant systemic antibiotic.
* Subject who has any underlying condition/disease, which would be likely to interfere with the completion of the course or absorption of study drug therapy or follow-up.
* Subject who has a severe or complicated lower respiratory tract infection or a severely compromised respiratory status (i.e., oxygen dependent, requiring hospitalization).
* Known significant renal or hepatic impairment.
40 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Locations
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Birmingham, Alabama, United States
Birmingham, Alabama, United States
Columbiana, Alabama, United States
Hoover, Alabama, United States
Mobile, Alabama, United States
Montgomery, Alabama, United States
Ozark, Alabama, United States
Glendale, Arizona, United States
Phoenix, Arizona, United States
Sun City West, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Camden, Arkansas, United States
Clovis, California, United States
Corona, California, United States
Fountain View, California, United States
Fresno, California, United States
Huntington Beach, California, United States
Lakewood, California, United States
Pasadena, California, United States
Rancho Cucamonga, California, United States
Roseville, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
San Jose, California, United States
Sylmar, California, United States
Temecula, California, United States
Torrance, California, United States
Upland, California, United States
Colorado Springs, Colorado, United States
Loveland, Colorado, United States
Wheat Ridge, Colorado, United States
Waterbury, Connecticut, United States
Brandon, Florida, United States
DeLand, Florida, United States
Fort Lauderdale, Florida, United States
Gainesville, Florida, United States
Largo, Florida, United States
Merritt Island, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Orlando, Florida, United States
Panama City, Florida, United States
Tallahassee, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Blue Ridge, Georgia, United States
Fort Gordon, Georgia, United States
Marietta, Georgia, United States
Rome, Georgia, United States
Coeur d'Alene, Idaho, United States
Chicago, Illinois, United States
Hines, Illinois, United States
Orland Park, Illinois, United States
Elkhart, Indiana, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Wichita, Kansas, United States
Lexington, Kentucky, United States
Murray, Kentucky, United States
Baton Rouge, Louisiana, United States
Metairie, Louisiana, United States
New Orleans, Louisiana, United States
Sunset, Louisiana, United States
Auburn, Maine, United States
Chester, Maryland, United States
DeWitt, Michigan, United States
Livonia, Michigan, United States
Saginaw, Michigan, United States
Saint Joseph, Michigan, United States
Chesterfield, Missouri, United States
Jefferson City, Missouri, United States
Springfield, Missouri, United States
St Louis, Missouri, United States
Missoula, Montana, United States
Omaha, Nebraska, United States
Blackwood, New Jersey, United States
Mount Laurel, New Jersey, United States
Toms River, New Jersey, United States
West Caldwell, New Jersey, United States
Astoria, New York, United States
Bronxville, New York, United States
Buffalo, New York, United States
Camillus, New York, United States
New York, New York, United States
Greensboro, North Carolina, United States
Winston-Salem, North Carolina, United States
Chardon, Ohio, United States
Mogadore, Ohio, United States
Toledo, Ohio, United States
Toledo, Ohio, United States
Zanesville, Ohio, United States
Oklahoma City, Oklahoma, United States
Eugene, Oregon, United States
Lake Oswego, Oregon, United States
Medford, Oregon, United States
Portland, Oregon, United States
Bensalem, Pennsylvania, United States
Fleetwood, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Ridley Park, Pennsylvania, United States
Cranston, Rhode Island, United States
East Providence, Rhode Island, United States
Bamberg, South Carolina, United States
Greer, South Carolina, United States
Simpsonville, South Carolina, United States
Spartanburg, South Carolina, United States
Chattanooga, Tennessee, United States
Clarksville, Tennessee, United States
Ducktown, Tennessee, United States
Johnson City, Tennessee, United States
New Tazewell, Tennessee, United States
Savannah, Tennessee, United States
Selmer, Tennessee, United States
Austin, Texas, United States
Beaumont, Texas, United States
Colleyville, Texas, United States
El Paso, Texas, United States
Fort Worth, Texas, United States
San Angelo, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Christianburg, Virginia, United States
Mechanicsville, Virginia, United States
Newport News, Virginia, United States
Richmond, Virginia, United States
Spokane, Washington, United States
Spokane, Washington, United States
Spokane, Washington, United States
Milwaukee, Wisconsin, United States
New Berlin, Wisconsin, United States
Coquitlam, British Columbia, Canada
Winnipeg, Manitoba, Canada
Kitchener, Ontario, Canada
Markham, Ontario, Canada
Mississauga, Ontario, Canada
Scarborough Village, Ontario, Canada
Toronto, Ontario, Canada
Sherbrooke, Quebec, Canada
Ste-Foy, Quebec, Canada
Saskatoon, Saskatchewan, Canada
San Juan, , Puerto Rico
Countries
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Other Identifiers
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M02-472
Identifier Type: -
Identifier Source: org_study_id