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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00288223 |
Study objectives:
Condition | Intervention | Phase |
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Bronchitis, Chronic |
Drug: Telithromycin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Multicenter Non Comparative Phase IV Study on the Safety and Efficacy of Telithromycin 800 mg Per Day for 5 Days in the Treatment of Acute Exacerbation of Chronic Bronchitis in Adults |
Enrollment: | 54 |
Study Start Date: | September 2005 |
Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
telithromycin
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Drug: Telithromycin
one daily intake of 800 mg (i.e. 2 x 400 mg tablets) per os in a single intake with a meal for 5 days.
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Ages Eligible for Study: | 35 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Presenting with an evident acute exacerbation of their disease defined by the presence of at least two of Anthonisen's criteria:
Exclusion Criteria:
Conditions associated with study medications:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | HMR3647A/4022 |
Study First Received: | February 6, 2006 |
Last Updated: | January 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00288223 History of Changes |
Health Authority: | Turkey: Ministry of Health |
Acute Disease Anti-Bacterial Agents Bronchitis, Chronic Lung Diseases, Obstructive Respiratory Tract Infections Respiratory Tract Diseases |
Bronchial Diseases Lung Diseases Bronchitis Telithromycin Pulmonary Disease, Chronic Obstructive |
Acute Disease Anti-Infective Agents Disease Attributes Bronchial Diseases Pharmacologic Actions Telithromycin Bronchitis, Chronic Anti-Bacterial Agents |
Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Diseases Respiratory Tract Infections Therapeutic Uses Lung Diseases Bronchitis Pulmonary Disease, Chronic Obstructive |