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    Summary
    EudraCT Number:2016-004321-16
    Sponsor's Protocol Code Number:CCOA566A2417
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-08-31
    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 number2016-004321-16
    A.3Full title of the trial
    A study of the effects of Coartem, Malarone and artesunate-mefloquine on auditory function in patients 12 years of age or older with acute uncomplicated P. falciparum malaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of the effects of Coartem, Malarone and artesunate-mefloquine on auditory function in patients 12 years of age or older with acute uncomplicated P. falciparum malaria
    A.4.1Sponsor's protocol code numberCCOA566A2417
    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 SponsorNovartis Pharma AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Investigative Site
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma AG
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressForum 1, Novartis AG
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4056
    B.5.3.4CountrySwitzerland
    B.5.6E-mailclinicaltrial.enquiries@novartis.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 Coartem/Riamet
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharmaceutical UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameRiamet
    D.3.2Product code COA566
    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 INNARTEMETHER
    D.3.9.1CAS number 71963-77-4
    D.3.9.2Current sponsor codeCOA566
    D.3.9.4EV Substance CodeSUB05574MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLUMEFANTRINE
    D.3.9.1CAS number 82186-77-4
    D.3.9.2Current sponsor codeCOA566
    D.3.9.4EV Substance CodeSUB08618MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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
    This study assessed the effects of artemether-lumefantrine on the auditory nerve pathway as assessed by Auditory Brainstem Response (ABR) and audiometric testing in acute uncomplicated Plasmodium falciparum malaria in patients 12 years of age or older.
    E.1.1.1Medical condition in easily understood language
    Malaria, Falciparum
    E.1.1.2Therapeutic area Diseases [C] - Parasitic Diseases [C03]
    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 demonstrate the safety of artemether-lumefantrine after 3 days of treatment in patients with acute, uncomplicated P. falciparum malaria by testing the null hypothesis that the rate of auditory brainstem pathway abnormalities is >= 15% in the population treated with artemether-lumefantrine, as assessed by ABR at Day 7 following initiation of treatment compared with their baseline values. An “auditory brainstem pathway abnormality” is here defined as a greater than 0.30 msec change in Wave III latency from baseline to Day 7.
    E.2.2Secondary objectives of the trial
    – To evaluate the safety of artemether-lumefantrine after 3 days of treatment in patients with acute, uncomplicated P. falciparum malaria by determining the descriptive changes from baseline in auditory function, evaluated by audiometric measurements at Day 3, 7, 28, and 42 following initiation of treatment.
    - To evaluate the efficacy by PCR adjusted malaria cure rates of the three treatment regimen at Days 14, 28, and 42, defined as the proportion of patients with clearance of asexual parasitemia within 7 days of initiation of trial treatment, without recrudescence within 14, 28 and 42 days, respectively, after initiation of treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Those patients who can be included in the study are:
    1. Male and female adults and children ≥ 12 years of age
    2. With microscopic confirmed diagnosis of acute uncomplicated P. falciparum malaria or mixed infection including P. falciparum using Giemsa-stained thick film
    3. With P. falciparum parasitemia of more than 1000 and less than 100,000 parasites/μL
    4. With history of fever or presence of fever (tympanic or axillary temperature ≥ 37.5°C)
    5. Who have signed or finger marked an informed consent form (for children below age of consent, with an informed consent signed or finger marked by their legal guardian/caretaker)
    E.4Principal exclusion criteria
    Those patients who can be excluded in the study are:
    1. Pregnant or lactating (urine test for β-HCG to be performed on any woman of child bearing age)
    2. With signs/symptoms indicative of severe/complicated malaria according to WHO
    classification
    3. History of any drug-related hearing impairment
    4. Chronic underlying disease such as known positive HIV status, sickle cell disease, and
    severe cardiac, renal, or hepatic impairment
    5. Other serious physical conditions e.g. history of head or brain trauma, previous severe or
    cerebral malaria, severe malnutrition, severe jaundice
    6. Known history of psychiatric disorders or convulsions
    7. Splenectomy
    8. Family history of long QT syndrome or sudden death, or any other clinical condition
    known to prolong the QTc interval, such as history of symptomatic cardiac arrhythmias,
    clinically relevant bradycardia or severe heart disease
    9. Known disturbances of electrolyte balance, e.g. hypokalaemia or hypomagnesaemia
    10. History of hypersensitivity to any of the study drugs or to any of their excipients or to
    chemically related compounds (e.g., for mefloquine, quinine and quinidine)
    11. Severe vomiting and unable to tolerate oral treatment
    12. Taking ingestion of any of the following drugs in the previous 2 months: mefloquine,
    aminoglycoside antibiotics, halofantrine, artemether-lumefantrine
    13. Taking ingestion of any of the following drugs in the previous 2 weeks: quinine,
    chloroquine (or any other antimalarial drug), ASA (acetylsalicylic acid), loop diuretics,
    macrolide antibiotics
    14. Taking drugs that are known to influence cardiac function and to prolong the QTc
    interval, such as class IA and III antiarrhythmics, neuroleptics, antidepressive agents and
    certain antibiotics (including some agents in the following classes: macrolides,
    fluoroquinolones, imidazoles and triazoles), antifungal agents, certain non-sedating
    antihistamines (terfenadine, astemizole) and cisapride
    15. Taking drugs metabolized by cytochrome CYP2D6 (e.g., flecainide, metoprolol,
    imipramine, amitriptyline, clomipramine)
    16. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives of enrollment, whichever is longer Audiology testing specific exclusion criteria

    • Current ear infections, ear discharge, prior middle ear or inner ear surgery, wearing a
    hearing aid, or unable to cooperate with audiological testing.
    • Cerumen completely or partially occluding the external auditory canal which cannot be
    removed by a physician using a cerumen curette or a simple apparatus for ear canal
    irrigation with mineral oil.
    • Abnormal tympanometry in either or both ears defined as Type B (“flat”, static
    compliance peak equal or less than 0.20 cm3) or Type C (“negative”) with peak pressure >
    -120 dPA. Normal static compliance is between 0.3 and 1.4 cm3.

    E.5 End points
    E.5.1Primary end point(s)
    Rate of ABR Wave III latency changes of > 0.3 msec
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Day 3, Day 7, Day 28, Day 42
    E.5.2Secondary end point(s)
    PCR adjusted malaria cure rates
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and Days 14, 28 and 42
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 Will this trial be conducted at a single site globally? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    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
    Colombia
    E.8.7Trial has a data monitoring committee Yes
    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 years1
    E.8.9.2In all countries concerned by the trial months6
    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: 265
    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) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 265
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 265
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children with assent form
    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 265
    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)
    Patients participating in this study receive treatment for their acute malaria infection. Patients are followed up until the infection is cured.
    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: Colombia
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