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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00799838 |
The purpose of this study is to evaluate the inflammatory symptoms and signs (hyperemia, edema and pain) reduction after 24 hours of treatment with ketoprofen drops when associated to amoxicillin.
Condition | Intervention | Phase |
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Acute Pharyngeal Tonsil |
Drug: Ketoprofen + amoxicillin Drug: placebo + amoxicillin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Local Study, National (Brazil), Phase IV, Multicentric, Double-Blind, Randomized, Parallel, With Two Arms of Treatment, Controlled by Placebo, for for Evaluation of the Inflammatory Symptoms Reduction in the Treatment of Acute Bacterial Pharyngeal Tonsillitis With Ketoprofen and Amoxicillin in Pediatric Patients |
Estimated Enrollment: | 210 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Ketoprofen+amoxicillin
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Drug: Ketoprofen + amoxicillin
Ten days treatment with Amoxicilin 125mg TID and ketoprofen: 1 drop/ Kg TID by oral administration
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2: Placebo Comparator
Placebo of ketoprofen+amoxicillin
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Drug: placebo + amoxicillin
Ten days treatment with Amoxicilin 125mg TID and placebo by oral administration
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Ages Eligible for Study: | 4 Years to 11 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contact: Public Registry GMA | publicregistrygma@sanofi-aventis.com |
Brazil | |
Sanofi-aventis | Recruiting |
Sao Paulo, Brazil |
Study Director: | Jaderson Lima, MD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | KETOP_L_03102 |
Study First Received: | November 28, 2008 |
Last Updated: | November 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00799838 |
Health Authority: | Brazil: National Health Surveillance Agency |
Ketoprofen Amoxicillin Otorhinolaryngologic Diseases Respiratory Tract Diseases |
Respiratory Tract Infections Tonsillitis Stomatognathic Diseases Pharyngeal Diseases |
Anti-Inflammatory Agents Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Anti-Bacterial Agents |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |