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These clinical study results are supplied for informational purposes only in the interests of scientific disclosure. They are not intended to substitute for the FDA-approved package insert or other approved labeling.

Drug Details

Company Name Business Partner Drug Name Generic Name Unique ID Studied Indications or Disease Phase Approved Drug Label
sanofi-aventis Ketek Telithromycin NCT00174694 Sinusitis, Acute Bacterial Phase IV US/ http://products.sanofi-aventis.us/ketek/ketek.html EU:http://www.emea.europa.eu/humandocs/Humans/EPAR/ketek/ketek.html Other: Refer to local approved drug label
Clinical Study Summary HMR3647A_4023

A prospective, randomized, Double-blind, active-controlled study in adults patients with Acute Maxillary Sinusitis (AMS) comparing telithromycin (Ketek®) 800 mg once a day for 5 days vs (Augmentin®) bid for 10 days at local recommended dosage (875 / 125 mg or 1000/125 mg)-CHOOSE.

-PMID 18559163
-Desrosiers M, Ferguson B, Klossek JM, Drugeon H, Mösges R.
-Clinical efficacy and time to symptom resolution of 5-day telithromycin versus 10-day amoxicillin-clavulanate in the treatment of acute bacterial sinusitis.
-Curr Med Res Opin. 2008 Jun;24(6):1691-702.
-http://www.ncbi.nlm.nih.gov/pubmed/18559163?ordinalpos=5&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

The summary result information on clinical trials is provided by the sanofi-aventis Group for informational purposes only and is not intended to promote any product or use. Summaries of clinical study results are intended to report the results of the study that were known at the time of the study’s completion. The summaries therefore do not provide a comprehensive and current review of the safety and efficacy of any drug based upon all information available, and the sanofi-aventis Group makes no representation or warranty of any kind as to the currency or completeness of the information contained in any summary, and disclaims all warranties, express or implied, with respect to such information. Healthcare Professionals should refer to the current approved product labeling for information on approved indications in their country. This information is not intended to replace the advice of a health care professional. Only a physician can determine if a specific medicine is the correct or best treatment option for a particular patient. If you have questions, please consult a health care professional.

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