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    Summary
    EudraCT Number:2013-001869-16
    Sponsor's Protocol Code Number:BRN-C-2013-02
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-07-03
    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
    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 ConcernedGermany - BfArM
    A.2EudraCT number2013-001869-16
    A.3Full title of the trial
    A randomised, multi-centre, parallel group, double-blind, placebo-controlled study to assess the efficacy and safety of Oscillococcinum® in the treatment of symptoms of Influenza-like illness (ILI)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to assess the efficacy and safety of Oscillococcinum® in the treatment of symptoms of influenza-like illness (ILI), when compared with placebo (a sugar pill without oscillococcinum). The study treatment is given in a randomised, parallel group, double-blind (neither patient or doctor aware of which treatment they have) manner, in several study centres.
    A.4.1Sponsor's protocol code numberBRN-C-2013-02
    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 SponsorBoiron Laboratoires
    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 supportBoiron Laboratories
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoiron Laboratoires
    B.5.2Functional name of contact pointStéphanie Villet -Research Projects
    B.5.3 Address:
    B.5.3.1Street Address20 Route de la Liberation
    B.5.3.2Town/ citySainte-Foy-les-Lyon
    B.5.3.3Post code69110
    B.5.3.4CountryFrance
    B.5.4Telephone number+334 72 16 41 95
    B.5.5Fax number+334 7859 69 16
    B.5.6E-mailstephanie.villet@boiron.fr
    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 Oscillococcinum Pillules
    D.2.1.1.2Name of the Marketing Authorisation holderBoiron
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    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 nameOscillococcinum Pillules
    D.3.4Pharmaceutical form Pillules
    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 INNN/A
    D.3.9.2Current sponsor codeOscillococcinum
    D.3.9.3Other descriptive nameAnas barbariae, hepatis et cordis extractum
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200CK 1×10−400
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboPillules
    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
    Systemic and respiratory symptoms of Influenza-like-illness (ILI)
    E.1.1.1Medical condition in easily understood language
    Flu -like symptoms
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10016797
    E.1.2Term Flu-like symptoms
    E.1.2System Organ Class 100000004867
    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 the efficacy of Oscillococcinum in the treatment of symptoms of ILI.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of Oscillococcinum in:
    -the reduction of symptoms duration
    -the reduction of symptoms severity
    -the improvement of patients’ quality of life
    -the development of secondary illnesses
    -the reduction of concomitant medication.

    To evaluate the patients' compliance regarding the use of Oscillococcinum

    To evaluate the tolerability of Oscillococcinum

    To evaluate the patients' and physicians' satisfaction regarding the efficacy and tolerability of Oscillococcinum

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Aged ≥ 12 and < 65 years of age.
    2. Patients with ILI defined as sudden onset of symptoms and at least one of the following systemic symptoms: fever (≥37.8°C) or chills, headache, myalgia, malaise (= assessment mild, moderate or severe for at least one of these symptoms) and at least one of the following respiratory symptom: cough, sore throat, shortness of breath (= assessment mild, moderate or severe for at least one of these symptoms), of less than or equal to 24 hours duration.
    3. Patients able to take the first dose of study medication in the first 24 hours of ILI.
    E.4Principal exclusion criteria
    1. Patients with active and clinically significant renal, cardiac, pulmonary, vascular, neurologic, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders, cancer, hepatitis, cirrhosis, asthma or chronic obstructive pulmonary disease (COPD)
    2. Participation in a clinical study with an investigational drug within 4 weeks prior to study entry
    3. Patients who experienced a previous episode of acute upper respiratory tract infection (URTI), sinusitis, bronchitis, otitis or pneumonia within 2 weeks prior to study day 0
    4. Patients taking steroids or immuno-suppressant therapies within 2 months prior to Study Day 0.
    5. Participants with evidence/history of alcoholism, drug abuse, psychiatric disorders or any other medical condition that could affect the study completion or the collection of the data relevant for safety or efficacy
    6. Patients with contraindications for paracetamol, e.g. liver insufficiency, severe renal insufficiency
    7. Treatment within 2 weeks prior to the Initial Visit with neuraminidase inhibitors, adamantanes or within 1 week with Oscillococcinum® or antibiotics
    8. Patients with a positive pharyngeal test for Group A streptococcus at inclusion
    8. Patients with any other disease that requires immediate start of antibiotic treatment.
    9. Pregnant or breast-feeding women.
    10. Patients with intolerance of fructose, malabsorption of glucose or galactose, sucrase/isomaltase deficit
    11. Any other condition which according to the investigator’s judgement is not compatible with the principles of the study, e.g. inability to give informed consent, inability to complete the diary
    E.5 End points
    E.5.1Primary end point(s)
    The first primary evaluation criterion is the time to absence of systemic flu-like symptoms.

    Time to absence of systemic flu-like symptoms is defined as follows: Time from first intake of study medication to the first occurrence of
    - no fever (body temperature <37.8°C)
    AND
    - chills, headache, myalgia, and malaise recorded as ‘none’.

    Scores of ‘none’ for chills, headache, myalgia, malaise, and fever have to be maintained over 24 hours.
    Symptoms are assessed as none, mild, moderate, or severe. The assessment of symptoms is to be done 3 times daily and to be documented in a patient diary.

    If the difference between Oscillococcinum and placebo is statistically significant for the time to absence of systemic flu-like symptoms, the time to absence of systemic flu-like symptoms AND to alleviation of respiratory flu-like symptoms will be tested as a co-primary endpoint.

    Time to absence of systemic AND alleviation of respiratory flu-like symptoms is defined as follows: Time from first intake of study medication to the first occurrence of:
    - absence of systemic flu-like symptoms as defined above
    AND
    - alleviation of cough, sore throat and shortness of breath, defined as follows:
    - if recorded as ‘moderate’ or ‘severe’ at inclusion: recorded as ‘none’ or ‘mild’
    - if recorded as ‘mild’ at inclusion: recorded as ‘none’
    - scores of ‘none’ or ‘mild’ have to be maintained over 24 hours.

    The primary evaluation criteria are efficacy evaluation criteria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After each treatment dose days 01-03 and follow up days 04-07
    E.5.2Secondary end point(s)
    To answer to the objective: evaluate efficacy on symptom duration:
    - Time to alleviate respiratory flu-like symptoms
    - Time to absence of systemic symptoms AND alleviation of respiratory flu-like symptoms as defined for the co-primary endpoint (if not tested as a co-primary endpoint)
    - Time to alleviate each symptom (all criteria of systemic flu-like symptoms plus all criteria of respiratory symptoms plus other symptoms (consisting of fatigue, nasal congestion and gastro-intestinal symptoms)).The definition of alleviation used for the respiratory symptoms for the co-primary endpoint is applied to all symptoms for this endpoint.
    -Time to absence of each symptom (all criteria of systemic flu-like symptoms plus all criteria of respiratory symptoms plus other symptoms (consisting of fatigue, nasal congestion and gastro-intestinal symptoms)). For absence, the definition applies that is used in the primary endpoint regarding absence of systemic symptoms.

    To answer to the objective: evaluate efficacy on symptoms severity:
    - Severity of symptoms after each dose of treatment in terms of total score for systemic flu-like symptoms and total score for respiratory flu-like symptoms. The total score for the systemic flu-like symptoms is the sum of the scores for each criterion of the systemic flu-like symptoms. The total score for the respiratory flu-like symptoms is the sum of the scores for each criterion of the respiratory flu-like symptoms.
    - Severity of each individual symptom after each dose of treatment
    -Proportion of patients with 50% reduction in total symptom score after each dose of treatment
    - Proportion of patients with 50% reduction in total score for systemic flu-like symptoms after each dose of treatment
    - Proportion of patients with 50% reduction in total score for respiratory flu-like symptoms after each dose of treatment
    - Severity of each individual symptom score after each dose of treatment
    - Proportion of patients with 50% reduction in the score for each symptom after each dose of treatment

    To answer to the objective: evaluate efficacy of Oscillococcinum in the improvement of patients’ quality of life:
    - Time to return to usual daily activities and perform these as normal. Usual daily activities will be captured using the following term ‘Activities you normally would have done today’. The activities will be assessed as ‘not possible’, ‘can be done with difficulties , and ‘can be done as normal’.
    - Sleep disturbance (number of days that sleep disturbance is recorded as ‘moderate’ or ‘severe’). Sleep disturbance will be captured using the following assessments: ‘severe’, ‘moderate’, ‘mild’, and ‘none’.
    -Number of days of absence from work/school (if applicable). These data will be captured by the investigator during the Final Visit.
    -Number of days with sick certificate (German:Krankschreibung): The days covered by a sick certificate will be recorded by the investigator during the Initial Visit and the Final Visit, as appropriate.

    To answer to the objective: evaluate efficacy of Oscillococcinum on the development of secondary illnesses:
    - Incidence of secondary complications of influenza-like illness such as sinusitis, bronchitis, otitis, pneumonia. Secondary complications will be captured within the documentation of adverse events.

    To answer to the objective: evaluate efficacy of Oscillococcinum on the reduction of concomitant medication:
    - Use of concomitant medication including: antipyretics / analgesics / decongestants, antibiotics / antivirals / herbal preparations.
    - Use of rescue medication paracetamol.

    To answer to the objective:evaluate the patients’ and physicians’ satisfaction regarding the efficacy of Oscillococcinum:
    - Treatment satisfaction regarding efficacy

    To answer to the objective: evaluate patients’ compliance regarding the use of Oscillococcinum
    - The patients’ intake of the study medication is documented in the diaries and assessed by counting the unused doses at the Final Visit

    To answer to the objective: evaluate the tolerability of Oscillococcinum
    - Occurrence of adverse events.
    - Changes in findings of the physical examination between the Initial Visit and the Final Visit.
    - Occurrence of unscheduled visits.
    - Treatment satisfaction regarding safety.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After each treatment dose days 01-03 and follow up days 04-07
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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) 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.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned30
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 is completed according to the protocol.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 120
    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: 120
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 480
    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 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 state590
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-05-14
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