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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00354965 |
Clinical research study to test amoxicillin and clavulanate tablet formulation for use in Acute Bacterial Sinusitis (ABS) in adolescent patients weighing at least 40 kilogram (kg) and no more than 16 years old. ABS is an acute bacterial infection of the sinus. The purpose of this study is to find out how children tolerate Augmentin XR and what happens to Augmentin XR in the body after it has been swallowed by children.
Condition | Intervention | Phase |
---|---|---|
Sinusitis, Acute Bacterial |
Drug: amoxicillin/clavulanate potassium |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | An Open-Label Study to Determine the Pharmacokinetic Profiles of Amoxicillin and Clavulanate in Adolescent Patients Weighing at Least 40 kg and no More Than 16 Years of Age Receiving Augmentin XR (Amoxicillin 2000 mg/Clavulanate 125 mg) Orally Twice Daily for 10 Days. |
Estimated Enrollment: | 52 |
Study Start Date: | January 2006 |
Ages Eligible for Study: | up to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
United States, Arkansas | |
GSK Investigational Site | |
Little Rock, Arkansas, United States, 72202 | |
United States, California | |
GSK Investigational Site | |
Huntington Beach, California, United States, 92647 | |
United States, North Carolina | |
GSK Investigational Site | |
Sylva, North Carolina, United States, 28779 | |
United States, Ohio | |
GSK Investigational Site | |
Cleveland, Ohio, United States, 44106 | |
United States, Pennsylvania | |
GSK Investigational Site | |
Erie, Pennsylvania, United States, 16506 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | AUG102821 |
Study First Received: | July 18, 2006 |
Last Updated: | October 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00354965 |
Health Authority: | United States: Food and Drug Administration |
Sinusitis Bacterial Sinusitis Acute Bacterial ABS |
Body Weight Amoxicillin Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases |
Clavulanic Acid Clavulanic Acids Sinusitis Amoxicillin-Potassium Clavulanate Combination |
Anti-Infective Agents Anti-Bacterial Agents Molecular Mechanisms of Pharmacological Action Paranasal Sinus Diseases |
Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions Nose Diseases |