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Pharmacokinetic Profiles Of Amoxicillin 2000 mg And Clavulanate 125 mg In Adolescent Patients
This study has been completed.
Study NCT00354965   Information provided by GlaxoSmithKline
First Received: July 18, 2006   Last Updated: October 6, 2008   History of Changes

July 18, 2006
October 6, 2008
January 2006
 
Pharmacokinetic data on amoxicillin/clavulanate [ Time Frame: Time above MIC (T>MIC)for amoxicillin when amoxicillin/clavulanate is given orally twice daily to adolescents. ]
Pharmacokinetic data on amoxicillin/clavulanate Time above MIC (T>MIC)for amoxicillin when amoxicillin/clavulanate is given orally twice daily to adolescents.
Complete list of historical versions of study NCT00354965 on ClinicalTrials.gov Archive Site
Safety, tolerability, and clinical response of oral amoxicillin/clavulanate [ Time Frame: twice daily for 10 days in adolescent patients. ]
Safety, tolerability, and clinical response of oral amoxicillin/clavulanate twice daily for 10 days in adolescent patients.
 
Pharmacokinetic Profiles Of Amoxicillin 2000 mg And Clavulanate 125 mg In Adolescent Patients
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.

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.

 
Phase I
Interventional
Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Sinusitis, Acute Bacterial
Drug: amoxicillin/clavulanate potassium
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
52
 
 

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.
Both
up to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00354965
Study Director, GSK
AUG102821
GlaxoSmithKline
 
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP