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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   Information provided by Abbott
First Received: March 24, 2008   Last Updated: March 26, 2008   History of Changes

March 24, 2008
March 26, 2008
December 2002
April 2004   (final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT00645086 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
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
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.

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.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB).
  • Drug: clarithromycin extended-release tablets
  • Drug: clarithromycin immediate-release tablets
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
465
 
April 2004   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Puerto Rico
 
NCT00645086
Angela M Nilius, Ph.D., Abbott
M02-472
Abbott
 
 
Abbott
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP