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    Summary
    EudraCT Number:2006-006165-17
    Sponsor's Protocol Code Number:L00013 CP 301
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2006-11-30
    Trial 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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2006-006165-17
    A.3Full title of the trial
    EFFICACY OF AN EARLY ADMINISTRATION OF L0013CP 10 MG/DAY VERSUS PLACEBO DURING 4 WEEKS IN THE TREATMENT OF INFECTIOUS DISEASES INDUCED ARTHRITIS PAINFUL SYMPTOMS.
    A MULTICENTER, RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED CLINICAL TRIAL IN ADULT PATIENTS SUFFERING FROM CHIKUNGUNYA FEVER.
    A.4.1Sponsor's protocol code numberL00013 CP 301
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPIERRE FABRE MEDICAMENT
    B.1.3.4CountryFrance
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 PRIMALAN
    D.2.1.1.2Name of the Marketing Authorisation holderPIERRE FABRE MEDICAMENT
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameMequitazine
    D.3.2Product code L0013 CP 02A
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNMequitazine
    D.3.9.1CAS number 29216-28-2
    D.3.9.2Current sponsor codeL0013 CP 02A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    CHIKUNGUNYA FEVER.
    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 evaluate in adults the efficacy of an early treatment by L0013CP 10 mg/day in comparison with placebo against painful arthritis symptoms experienced in chikungunya fever, over the first 7-day treatment period after the first symptoms.
    E.2.2Secondary objectives of the trial
    To evaluate in adults the efficacy of an early treatment by mequitazine 10 mg/day in comparison with placebo against painful arthritis symptoms experienced in chikungunya fever over the first 14-day and the 28-day treatment period

    To evaluate in adults the efficacy of an early treatment by mequitazine 10 mg/day in comparison with placebo against possible dermatological symptoms (such as pruritus) and ophthalmologic symptoms experienced in chikungunya fever over the 28-day treatment period;

    To evaluate the quality of life (QoL) of patients suffering from chikungunya fever treated with mequitazine 10 mg/day in comparison with placebo, over the 28-day treatment period

    To evaluate the proportion of patients using paracetamol and the dose of paracetamol over the 28-day-treatment period

    To evaluate the proportion of patients responding to mequitazine 10 mg/day in comparison with those receiving the placebo, for painful symptoms of joint arthritis over the 28-day treatment period
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    Will be included in the study those subjects who meet the following criteria:
    · Male and female patients aged more than 18 years;
    · Suspected of suffering from chikungunya fever whose the following criteria have appeared for ≤48 hours:
    o Arthritic pain involving of at least 2 peripheral joints;
    o Fever ≥ 38°C
    o Cephalalgia.
    Other common criteria such as cutaneous eruption, myalgia can complete the clinical picture.
    NB: a further confirmation of the diagnosis will be obtained by laboratory analysis. Only patients with a serology-confirmed diagnosis will be conserved in the data sets to be analysed for efficacy;
    · Presence of a moderate to severe arthritis-like joint pain, defined as leading to a PI-NRS ≥4 on the most painful joint at first clinical examination;
    · Able to understand the protocol, to comply with its requirements and to attend to visits;
    · Able to give their written informed consent to participate in the study;
    · Subjects who, according to the judgment of the Investigator, are likely to be compliant during the study;
    · If required by national regulations, registered with a social security or health insurance system;
    · For women of childbearing potential, contraceptive method.
    E.4Principal exclusion criteria
    Will not be included subjects who have at least one of the following criteria:
    · Criteria related to pathologies:
    o Who experience symptoms (fever or joint pain) from suspected chikungunya from > 48 hours;
    o History of proved chikungunya disease;
    o Past history of major medical, psychiatric disease or surgery which, in the judgment of the Investigator, could jeopardize their health or likely to modify their handling of the study drug;
    o Acute or chronic systemic disease or disorder;
    o Past history of hypersensitivity (abnormal drug reaction or idiosyncrasy or asthma) to mequitazine or its excipients;
    o Known narrow-angle glaucoma;
    o Known prostatic hypertrophy;
    o History of agranulocytosis;
    o Congenital galactosemia, glucose or galactose malabsorbtion syndrome, lactase deficiency;
    o Severe liver impairment;
    o Epileptic subject;
    o Any allergic disease (rhinitis, asthma, urticaria) requiring a continuous or discontinuous treatment;
    o Current ongoing infectious or rheumatoid disease or autoimmune disease;
    o Concomitant dengue infection.

    · Criteria related to treatments:
    o Treatment by a systemic anti-histamine drug within the previous 4 weeks;
    o Treatment by a systemic or local non-steroidal anti-inflammatory drugs (NSAIDs) within the previous week;
    o Treatment by depot corticosteroid treatment within the previous 6 months;
    o Treatment by oral or systemic corticosteroids within the previous 4 weeks;
    o Treatment by atropine or atropine-like drug within the previous week;
    o Treatment by a central nervous system depressant within the previous month;
    o Regular use of sedatives, hypnotics, tranquilizers or any illicit drug of abuse.
    · Criteria related to the way of life:
    o Known history of alcohol abuse (consumption > 28 units of alcohol / week);
    Known history of illicit drug of abuse.

    · Criteria related to the population:
    o Pregnancy or suspicion of pregnancy (for women of childbearing potential), breast feeding;
    o Known congenital or acquired immuno-deficiency;
    o Participation in another clinical trial during the previous month or planned participation during the study;
    o Subject who has forfeited his freedom by administrative or legal award, or who is under guardianship.
    E.5 End points
    E.5.1Primary end point(s)
    Primary assessment criterion:
    Arthritis-like joint pain symptoms will be assessed through a 11-point numerical pain rating scale (PI-NRS, graded from 0 = no pain to 10 = worst possible pain) for joint pain (evaluated on the most painful joint) at rest at D0, then after 7 ± 1 days of treatment.

    For the primary efficacy criterion, the percentage change in PI-NRS score from baseline to 7 ± 1 days of treatment will be compared between mequitazine and placebo using an analysis of covariance (ANCOVA). Baseline PI-NRS score and country will be included in the model as covariates.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Yes
    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.4.1In the member state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 300
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-12-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-20
    P. End of Trial
    P.End of Trial StatusOngoing
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