| 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
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| |
| |
| |
| 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.
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| 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 |
|
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| Abbott |
| March 2008 |