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