Pharmacokinetic Profiles Of Amoxicillin 2000 mg And Clavulanate 125 mg In Adolescent Patients
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: 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, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
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: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Primary outcome: Pharmacokinetic data on amoxicillin/clavulanate
Secondary outcome: Safety, tolerability, and clinical response of oral amoxicillin/clavulanate
Eligibility
Minimum age: N/A.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
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
antibiotics.
- 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 Clinical Trials Call Center, Little Rock, Arkansas 72202, United States
GSK Clinical Trials Call Center, North Dartmouth, Massachusetts 02747, United States
GSK Clinical Trials Call Center, Sylva, North Carolina 28779, United States
GSK Clinical Trials Call Center, Cleveland, Ohio 44106, United States
GSK Clinical Trials Call Center, Erie, Pennsylvania 16506, United States
Additional Information
Starting date: January 2006
Last updated: August 16, 2007
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