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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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
  • Patient weighs at least 40 kg.
  • Younger than 16 years old (no older than their 16th birthday).
  • 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).
Inclusion and exclusion 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
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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
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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
Completed
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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