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Pharmacokinetic Profiles Of Amoxicillin 2000 mg And Clavulanate 125 mg In Adolescent Patients

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infections, Respiratory Tract; Sinusitis, Acute Bacterial

Intervention: amoxicillin/clavulanate potassium (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline


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.

Clinical Details

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.

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Pharmacokinetic data on amoxicillin/clavulanate

Secondary outcome: Safety, tolerability, and clinical response of oral amoxicillin/clavulanate


Minimum age: N/A. Maximum age: 16 Years. Gender(s): Both.


Inclusion criteria:

- Patient weighs at least 40 kg.

- Younger than 16 years old (no older than their 16th birthday).

- Suspected acute bacterial sinusitis.

- Able to swallow amoxicillin/clavulanate tablets.

Exclusion criteria:

- Personal or family history of adverse reactions or hypersensitivity or allergy to any

penicillin or cephalosporin antibiotics.

- History of reaction to multiple allergens (if considered clinically relevant by the

principal investigator).

- Patient is participating in another clinical trial or has received or anticipates

receiving an investigational drug, vaccine, or medical device prior to the first dose of study medication or during the conduct of the study.

- History or presence of gastrointestinal, hepatic or renal disease or other conditions

known to or that may interfere with the absorption, distribution, metabolism or excretion of study medication.

- Treatment with probenecid or allopurinol within 7 days of study entry.

- Female patients with a positive urine hCG (human chorionic gonadotropin) test at

screening, or who are lactating (breast feeding) or are unwilling to be abstinent until completion of the follow-up visit.

- History of diarrhea due to Clostridium difficile following treatment with


- History of hypersensitivity or allergy to heparin or related preparations (if the

clinical research unit uses heparin to maintain intravenous cannula patency).

- Patient is diagnosed with mononucleosis.

- Estimated Glomerular Filtration Rate (GFR) <40 ml/min.

Locations and Contacts

GSK Investigational Site, Little Rock, Arkansas 72202, United States

GSK Investigational Site, Huntington Beach, California 92647, United States

GSK Investigational Site, Sylva, North Carolina 28779, United States

GSK Investigational Site, Cleveland, Ohio 44106, United States

GSK Investigational Site, Erie, Pennsylvania 16506, United States

Additional Information

Starting date: January 2006
Last updated: May 31, 2012

Page last updated: August 23, 2015

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