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CompletedNCT00354965Updated Aug 1, 2017

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

A Phase 1 interventional study of amoxicillin/clavulanate potassium in Infections, Respiratory Tract, sponsored by GlaxoSmithKline. Completed at 6 sites in United States. Open to participants aged Up to 16 Years. Per ClinicalTrials.gov, last updated 2017-08-01.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jan 2006, registered Jul 2006).
Phase
Phase 1
Study type
Interventional
Enrollment
52
Allocation
Non-randomized
Ages
Up to 16 Years
Sex
All
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Study 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.

02

Conditions studied

  • Infections, Respiratory Tract

Keywords

  • ABS
  • Acute Bacterial
  • Sinusitis
  • Bacterial Sinusitis
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In context

Respiratory Tract Infections

1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.

This study's enrollment of 52 is below the median of 199 across 698 interventional studies indexed under Respiratory Tract Infections.

Browse Respiratory Tract Infections studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    ARM 1

    Drug: amoxicillin/clavulanate potassium

Interventions

  • Drugamoxicillin/clavulanate potassium

    amoxicillin/clavulanate potassium

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What researchers measure

Primary outcomes

  1. Pharmacokinetic data on amoxicillin/clavulanate

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

Secondary outcomes

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

    Time frame: twice daily for 10 days in adolescent patients.

07

Study locations

6 sites
  • GSK Investigational Site
    Little Rock, Arkansas 72202, United States
  • GSK Investigational Site
    Huntington Beach, California 92647, United States
  • GSK Investigational Site
    North Dartmouth, Massachusetts 02747, 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
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References and documents

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00354965
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jul 20, 2006
Start date
Jan 19, 2006
Primary completion
Apr 2, 2007
Completion
Apr 2, 2007
Last update
Aug 1, 2017

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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