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    Summary
    EudraCT Number:2010-021422-35
    Sponsor's Protocol Code Number:09-NI-EP-001
    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:2010-08-13
    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 number2010-021422-35
    A.3Full title of the trial
    Efficacy, safety and tolerability of Influcid tablets in patients (1 to 65 years old) suffering from upper respiratory tract infections with flu-like symptoms.
    A randomized, international, multicenter, controlled clinical trial.
    A.3.2Name or abbreviated title of the trial where available
    INFI (Influcid in Feverish Infections)
    A.4.1Sponsor's protocol code number09-NI-EP-001
    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 SponsorDeutsche Homöopathie-Union, DHU-Arzneimittel GmbH & Co. KG
    B.1.3.4CountryGermany
    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 Nisylen (Tabletten)
    D.2.1.1.2Name of the Marketing Authorisation holderDeutsche Homöopathie-Union
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical 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.3.9.2Current sponsor codeAconitum trit. D3
    D.3.9.3Other descriptive nameACONITUM
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeBryonia trit. D2
    D.3.9.3Other descriptive nameBRYONIA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeEupatorium perfoliatum trit. D1
    D.3.9.3Other descriptive nameEUPATORIUM PERFOLIATUM
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeGelsemium trit. D3
    D.3.9.3Other descriptive nameGELSEMIUM
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeIpecacuanha trit. D3
    D.3.9.3Other descriptive nameIPECACUANHA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 7723-14-0
    D.3.9.2Current sponsor codePhosphorus trit. D5
    D.3.9.3Other descriptive namePHOSPHORUS
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) Yes
    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 Yes
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 ben-u-ron Saft
    D.2.1.1.2Name of the Marketing Authorisation holderbene-Arzneimittel GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Syrup
    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 INNPARACETAMOL
    D.3.9.1CAS number 103-90-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Mucosolvan Hustensaft 30 mg/5ml
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim Pharma
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Syrup
    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 INNAmbroxol
    D.3.9.1CAS number 15942-05-9
    D.3.9.3Other descriptive nameAMBROXOL HYDROCHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Nasivin ohne Konservierungsstoffe Dosierspray für Erwachsene und Schulkinder
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Selbstmedikation GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXYMETAZOLINE
    D.3.9.1CAS number 08/02/2315
    D.3.9.3Other descriptive nameoxymetazoline hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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.IMP: 5
    D.1.2 and D.1.3IMP RoleComparator
    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 Nasivin ohne Konservierungsstoffe Dosierspray für Kleinkinder
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Selbstmedikation GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXYMETAZOLINE
    D.3.9.1CAS number 08/02/2315
    D.3.9.3Other descriptive nameoxymetazoline hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diagnosed upper respiratory tract infection (URTI) with presence of the following symptoms for equal or less than for 24 hours :
    a)Fever (axillary temperature >= 37.5°C) and
    b)At least one upper respiratory tract symptom: either
    i) one nasal symptom or ii) one pharyngeal symptom or iii) cough and
    c) at least one general symptom: either i) feeling tired or ii) weakness or iii) body aches or iv) for children only: irritable / whiny or less active.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10046734
    E.1.2Term URTI (upper respiratory tract infection)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. Fraction of patients with symptoms alleviation at day 4 of the study.
    Symptoms alleviation is defined as:
    - Absence of fever (axillary temperature ≤ 37.2°C) and
    - Absence or very mild degree of the symptoms assessed by Wisconsin Upper Respiratory Symptom Survey 21 (WURSS-21).
    Fever will be measured 3-times daily by the patient (or in case of children by their parents) at home. Mean value covering last 24 hours will be basis for this definition.
    Absence or very mild degree of symptoms is defined as answer to question “How sick do you feel today?” with “0” (not sick) or “1” (very mildly) for both assessments at day 4 (WURSS-21 is filled in twice daily by the patient or in case of children by their parents at home).
    E.2.2Secondary objectives of the trial
    2. Time to symptoms alleviation;
    3. Fraction of patients with symptoms alleviation as defined for primary objective at study day 2, 3, 5, etc. until end of study as well as fraction of subjects who maintained symptoms alleviation at the different time points (day 3, 4, 5, etc);
    4. Time to return to normal daily activity;
    5. Time to resolution of individual symptoms (analyzed via WURSS-21);
    6. Area under the curve (AUC) describing severity and course of the infection;
    7. Total amount, amount per day and duration of Paracetamol, Ambroxol and Oxymetazoline consumption;
    8. Fraction of patients who must be withdrawn from the study due to prohibited medication;
    9. Treatment outcome according to Integrative Medicine Outcomes Scale (IMOS);
    10. Satisfaction with treatment according to Integrative Medicine Patient Satisfaction Scale (IMPSS);
    11. Tolerability of treatment;
    12. Incidence of complications, adverse events, and adverse drug reactions.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females aged from 1 to 65 years;
    2. Diagnosed URTI with presence of the following symptoms for equal or less than for 24 hours:
    a) Fever (axillary temperature ≥ 37.5°C) and
    b) At least one upper respiratory tract symptom: either
    i) one nasal symptom (plugged nose, runny nose, sneezing) or
    ii) one pharyngeal symptom (scratchy throat, sore throat, pharynx hyperemia) or
    iii) cough (ordinary cough without suspicion of acute lower respiratory tract disease) and
    c) at least one general symptom: either
    i) feeling tired or
    ii) weakness or
    iii) body aches or
    iv) for children only: irritable / whiny or less active.
    3. Written informed consent according to the applicable law;
    4. Willingness and ability to comply with all procedures of the trial.
    E.4Principal exclusion criteria
    Subjects presenting any of the following criteria will not be included in the study:
    1. Severe or complicated course of the URTI (e.g. shortness of breath, dyspnoea, tachypnea, hypoxia, central nervous system (CNS) findings, severe dehydration, renal failure, multi-organ failure, septic shock, musculoskeletal (rhabdomyolysis) and cardiac (myocarditis) complications);
    2. Signs of acute lower respiratory tract disease (e.g. bronchiolitis, bronchitis, pneumonia);
    3. Current symptoms mainly induced by other acute ENT (Ear-Nose-Throat) disease such as tonsillitis, sinusitis, otitis media;
    4. Any present chronic inflammatory ENT and respiratory tract disease (e.g. allergic rhinitis, bronchitis, bronchial asthma, obstructive pulmonary disease (COPD), cystic fibrosis and adenoidal hypertrophy);
    5. Obstructive anatomic lesions in the nasopharynx such as nasal polyps, tumours or severe septal deviations;
    6. Patients with severe heart diseases, HIV-infection, unstable diabetes mellitus, coeliac disease and/or immunosuppression and only for adolescents-adults tuberculosis as well as lues at any stage;
    7. Patients with severe renal or hepatic dysfunction at any time during the past 12 months prior to enrolment into the trial;
    8. Children with congenital anomalies of heart, kidney or liver;
    9. Any significant alarm symptom within the past 6 months prior to enrolment into the trial, e.g. unintentional weight loss, or any other sign indicating serious or malignant disease;
    10. Evidence of any malignant disease during the past 5 years prior to enrolment into the trial;
    11. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption;
    12. Hypersensitivity to any of the ingredients and/or excipients of Influcid;
    13. Hypersensitivity to any of the ingredients and/or excipients as well as any known contraindications to the symptomatic treatment defined in this protocol;
    14. Positive rapid test for group A β-hemolytic streptococci (GABHS);
    15. Treatment with antibiotics, glucocorticosteroids, immunomodulators (including drugs contraining probiotics), or antihistamines during the past 4 weeks prior to or at enrolment into the trial as well as current indication requiring these drugs during the trial;
    16. Indication for administration of or treatment with antiviral drugs (e.g. oseltamivir);
    17. Treatment with any antipyretics, nasal decongestants, expectorants and/or any other cold medication or measure for relief of URTI e.g. local anesthetics, anti-inflammatory drugs, antitussiva, homeopathic drugs, nutritional supplements or drugs containing zinc, echinacea, garlic or vitamin C (³ 100 mg per day), during the past 7 days prior to or at enrolment into the trial;
    18. Heavy smoking or known or suspected drug addiction incl. alcohol abuse;
    19. Women of childbearing potential without adequate contraception or women, who want to become pregnant, are pregnant or breast-feeding;
    20. Participation in another clinical trial during the past 3 months prior to enrolment into the trial;
    21. For patients ≥ 18 years: Incompetence or incapability of understanding nature, meaning and consequences of the trial;
    For patients < 18 years: Irresponsible parents or their legal representatives unable to understand nature, meaning and consequences of the trial.
    E.5 End points
    E.5.1Primary end point(s)
    Number of responders (patients without fever (axillary temperature ≤ 37.2°C) and without symptoms or with very mild degree of the symptoms only as assessed by item 1 of WURSS-21) at day 4.
    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 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) 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 Yes
    E.8.1.7.1Other trial design description
    add-on trial: all receive PR2, PR3 and/or PR4/PR5; one group will receive additionally Influcid
    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.8.3 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 concerned14
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    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.1.1.1In 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) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-08-13. Yes
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 520
    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)
    Uncomplicated URTI are usually self-limited illnesses and the symptoms generally resolve after a week. In cases the symptoms persist at the end of the study (day 15) or the patients premature discontinue the participation in the study, they will receive a standard therapy, adapted to their disease, at the discretion of the investigator.
    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 Decision2010-09-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-07-04
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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