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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00354965
First received: July 18, 2006
Last updated: May 31, 2012
Last verified: January 2012
History of Changes

July 18, 2006
May 31, 2012
January 2006
April 2007   (final data collection date for primary outcome measure)
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.
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Infections, Respiratory Tract
  • Sinusitis, Acute Bacterial
Drug: amoxicillin/clavulanate potassium
amoxicillin/clavulanate potassium
Other Name: amoxicillin/clavulanate potassium
Experimental: ARM 1
Intervention: Drug: amoxicillin/clavulanate potassium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
April 2007
April 2007   (final data collection date for primary outcome measure)

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
AUG102821
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2012

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