ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
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

This study has been completed.
Study NCT00645086.   Last updated on March 26, 2008.   Information provided by Abbott

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  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
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.
Brief Summary

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.

Detailed Description
Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Primary Outcome Measure  Clinical Response [ Time Frame: 23 days ] [ Designated as safety issue: No ]
Bacteriologic Response [ Time Frame: 23 days ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Adverse events assessment [ Time Frame: 42 days with follow-up to a satisfactory conclusion ] [ Designated as safety issue: Yes ]
Physical exam; Vital signs; Use of other medications and supplements [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
Laboratory evaluations [ Time Frame: 23 days ] [ Designated as safety issue: Yes ]
Condition  Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB).
Intervention  Drug: clarithromycin extended-release tablets
Drug: clarithromycin immediate-release tablets
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  465
Start Date  December 2002
Completion Date
Eligibility Criteria 

Inclusion Criteria:

  • Ambulatory subject who does not require intravenous antibiotic therapy.
  • 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:

  • Medical history of hypersensitivity, allergic or adverse reactions to clarithromycin, erythromycin, or any of the macrolide antibiotics.
  • 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.
Gender Both
Ages 40 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States,   Canada,   Puerto Rico
Administrative Information Fields
NCT ID  NCT00645086
Organization ID M02-472
Secondary IDs ††
Study Sponsor  Abbott
Collaborators ††
Investigators 
Information Provided By Abbott
Verification Date March 2008
First Received Date  March 24, 2008
Last Updated Date March 26, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers