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

Primary Purpose

Infections, Respiratory Tract

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
amoxicillin/clavulanate potassium
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infections, Respiratory Tract focused on measuring ABS, Acute Bacterial, Sinusitis, Bacterial Sinusitis

Eligibility Criteria

undefined - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ARM 1

Arm Description

Outcomes

Primary Outcome Measures

Pharmacokinetic data on amoxicillin/clavulanate

Secondary Outcome Measures

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

Full Information

First Posted
July 18, 2006
Last Updated
July 31, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00354965
Brief Title
Pharmacokinetic Profiles Of Amoxicillin 2000 mg And Clavulanate 125 mg In Adolescent Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 19, 2006 (Actual)
Primary Completion Date
April 2, 2007 (Actual)
Study Completion Date
April 2, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Respiratory Tract
Keywords
ABS, Acute Bacterial, Sinusitis, Bacterial Sinusitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARM 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
amoxicillin/clavulanate potassium
Intervention Description
amoxicillin/clavulanate potassium
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Safety, tolerability, and clinical response of oral amoxicillin/clavulanate
Time Frame
twice daily for 10 days in adolescent patients.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
GSK Investigational Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
GSK Investigational Site
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
GSK Investigational Site
City
Sylva
State/Province
North Carolina
ZIP/Postal Code
28779
Country
United States
Facility Name
GSK Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
GSK Investigational Site
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AUG102821
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AUG102821
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AUG102821
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AUG102821
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AUG102821
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AUG102821
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

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

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