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    Summary
    EudraCT Number:2015-004874-13
    Sponsor's Protocol Code Number:AUG102821
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-08-03
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2015-004874-13
    A.3Full title of the trial
    An open label study to determine the pharmacokinetic profiles of
    amoxicillin and clavulanate in adolescent patients weighing at least 40kg
    and no more than 16 years of age receiving AUGMENTIN™XR (amoxicillin
    2000mg/clavulanate 125mg) orally twice daily for 10 days.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Determination of the administration, distribution, metabolism and elimination profiles of amoxicillin and clavulanate in adolescents patients weighing at least 40kg and no more than 16 years old receiving Augmentin XR with oral use, twice a day for 10 days.
    A.4.1Sponsor's protocol code numberAUG102821
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00354965
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGSK Research and Development
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd.
    B.5.2Functional name of contact pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4408007839733
    B.5.6E-mailGSLClinicalSupportHD@gsk.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Augmentin XR
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAugmentin XR
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMOXICILLIN
    D.3.9.1CAS number 26787-78-0
    D.3.9.4EV Substance CodeSUB05481MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNClavulanate
    D.3.9.3Other descriptive namePOTASSIUM CLAVULANATE
    D.3.9.4EV Substance CodeSUB12232MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    acute bacterial sinusitis
    E.1.1.1Medical condition in easily understood language
    sinusitis
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To obtain pharmacokinetic data on amoxicillin/clavulanate and time above MIC
    (T>MIC) for amoxicillin when AUGMENTIN XR (amoxicillin 2000 mg/clavulanate
    125 mg) is given orally twice daily to adolescents weighing at least 40 kg.
    E.2.2Secondary objectives of the trial
    To assess the safety, tolerability, and clinical response of oral AUGMENTIN XR
    twice daily for 10 days in adolescent patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient is a male or female who weighs at least 40 kg and is younger than 16 years
    old (no older than their 16th birthday), inclusive.
    2. Patients must be able to swallow AUGMENTIN XR tablets.
    3. Patients with suspected acute bacterial sinusitis that may benefit from administration
    of AUGMENTIN XR (in the opinion of the PI) and who are not considered to be at
    risk of clinically significant adverse effects at the dose specified in the protocol.
    4. Written informed consent by the patient’s parent or legal guardian and where
    appropriate, written assent of the volunteer.
    E.4Principal exclusion criteria
    Definite or suspected personal history or family history of adverse reactions or
    hypersensitivity or allergy to any penicillin or cephalosporin antibiotics. Also
    history of reaction to multiple allergens (if considered clinically relevant by the
    principal investigator).
    2. Patients weighing less than 40 kg or older than 16 years of age (i.e., past their 16th
    birthday).
    3. Patient is participating in another clinical trial or has received or anticipates
    receiving an investigational drug, vaccine, or medical device (non-government)
    within 30 days (or 5-half-lives, whichever is longer) prior to the first dose of study
    medication or during the conduct of the study.
    4. 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.
    5. Treatment with probenecid or allopurinol within 7 days of study entry.
    6. A positive urine β-hCG (human chorionic gonadotropin) test at screening (female
    patients only) indicating pregnancy.
    7. Female patients who are lactating (breast feeding).
    8. Female patients who are unwilling to be abstinent until completion of the follow-up
    visit.
    9. History of diarrhea due to Clostridium difficile following treatment with antibiotics.
    10. History of hypersensitivity or allergy to heparin or related preparations (if the
    clinical research unit uses heparin to maintain intravenous cannula patency).
    11. Patient is diagnosised with mononucleosis.
    12. Estimated Glomerular Filtration Rate (GFR) <40 ml/min (refer to SRM for GFR
    calculation formula).
    13. Any condition, which in the opinion of the investigator, contraindicates the
    administration of AUGMENTIN XR.
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetic parameters will be T>MIC for amoxicillin (for an amoxicillin MIC of 2
    ug/mL and 4ug/mL), Cmax, tmax, t1/2, AUC(0-t), AUC(0-τ), and AUC(0-∞) for
    amoxicillin and for clavulanate.
    E.5.1.1Timepoint(s) of evaluation of this end point
    T>MIC: over the 12 hour dosing interval for an MIC of 2ug/mL and 4ug/mL

    All the other parameters: evaluated for patients on any one given dosing day in which Augmentin XR was administered over a 12 hour dosing period with samples at pre-dose 0.5, 1, 1.5, 2, 4, 5, 6, 7, 8, 10 and 12 hours after the administration of study medication
    E.5.2Secondary end point(s)
    Adverse experiences will be monitored throughout the study by spontaneous
    patient/parent-guardian reporting, direct questioning and physician/nursing observation,
    clinical responses, and clinical laboratory tests.
    E.5.2.1Timepoint(s) of evaluation of this end point
    throughout the study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months14
    E.8.9.2In all countries concerned by the trial days14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 44
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 21
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 23
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 52
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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