Last updated: 11/04/2018 05:10:33

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

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GSK study ID
AUG102821
See study documents
Clinicaltrials.gov ID
NCT00354965
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A study to determine PK profiles of AUGMENTIN XR in adolescents weight at least 40 kg receiving Augmentin XR BID for 10 days
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Pharmacokinetic data on amoxicillin/clavulanate

Timeframe: Time above MIC (T>MIC)for amoxicillin when amoxicillin/clavulanate is given orally twice daily to adolescents.

Secondary outcomes:

Safety, tolerability, and clinical response of oral amoxicillin/clavulanate

Timeframe: twice daily for 10 days in adolescent patients.

Interventions:
  • Drug: amoxicillin/clavulanate potassium
    • Enrollment:
    52
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Infections, Respiratory Tract
    Product
    amoxicillin, amoxicillin/clavulanic acid, clavulanic acid
    Collaborators
    Not applicable
    Study date(s)
    January 2006 to April 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable - 16 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Patient weighs at least 40 kg.
    Inclusion and exclusion criteria
    Inclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Huntington Beach, California, United States, 92647
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Erie, Pennsylvania, United States, 16506
    Status
    Study Complete
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    Location
    GSK Investigational Site
    North Dartmouth, Massachusetts, United States, 02747
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Little Rock, Arkansas, United States, 72202
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sylva, North Carolina, United States, 28779
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cleveland, Ohio, United States, 44106
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-02-04

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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    Additional information
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    Results for study AUG102821 can be found on the GSK Clinical Study Register.
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