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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00354965 |
Purpose
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 |
|---|---|---|
|
Infections, Respiratory Tract Sinusitis, Acute Bacterial |
Drug: amoxicillin/clavulanate potassium |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
| Enrollment: | 52 |
| Study Start Date: | January 2006 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ARM 1 |
Drug: amoxicillin/clavulanate potassium
amoxicillin/clavulanate potassium
Other Name: amoxicillin/clavulanate potassium
|
Eligibility| Ages Eligible for Study: | up to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| 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 | GlaxoSmithKline |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00354965 History of Changes |
| Other Study ID Numbers: | AUG102821 |
| Study First Received: | July 18, 2006 |
| Last Updated: | January 12, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
ABS Acute Bacterial Sinusitis Bacterial Sinusitis |
|
Respiratory Tract Infections Sinusitis Infection Respiratory Tract Diseases Paranasal Sinus Diseases Nose Diseases Otorhinolaryngologic Diseases Amoxicillin Amoxicillin-Potassium Clavulanate Combination |
Clavulanic Acids Clavulanic Acid Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |