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    The EU Clinical Trials Register currently displays   42782   clinical trials with a EudraCT protocol, of which   7047   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-000341-13
    Sponsor's Protocol Code Number:OTV.PRE.01
    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:2012-04-25
    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 number2012-000341-13
    A.3Full title of the trial
    Efficacy and Safety of an Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence: A Placebo Controlled, Randomized, Double-blinded Parallel-Group Comparison for Superiority
    Wirksamkeit und Sicherheit eines Arzneimittels auf pflanzlicher Basis im Vergleich mit Placebo zur Vorbeugung akuter Mittelohrentzündungen bei Kindern mit hohem Rezidivrisiko
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Does a herbal-based medicine compared with a placebo (dummy drug) reduce the number of episodes with middle ear infection?
    Reduziert ein Medikament auf pflanzlicher Basis im Vergleich mit einem unwirksamen Scheinmedikament (Placebo) die Häufigkeit von Mittelohrentzündungen?
    A.3.2Name or abbreviated title of the trial where available
    AOM Prevention
    Prävention akuter Mittelohrentzündungen
    A.4.1Sponsor's protocol code numberOTV.PRE.01
    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 SponsorWeber & Weber 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 supportWeber & Weber GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWeber & Weber GmbH & Co. KG
    B.5.2Functional name of contact pointMed. Wiss. Dr. rer. nat. U. Danesch
    B.5.3 Address:
    B.5.3.1Street AddressHerrschinger Str. 33
    B.5.3.2Town/ cityInning/Ammersee
    B.5.3.3Post code82266
    B.5.3.4CountryGermany
    B.5.4Telephone number4981439270
    B.5.5Fax number4981437084
    B.5.6E-maildanesch@weber-weber.net
    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 Otovowen
    D.2.1.1.2Name of the Marketing Authorisation holderWeber & Weber GmbH & Co. KG
    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 Oral drops, solution
    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 INNECHINACEA PURPUREA
    D.3.9.1CAS number 8001002-85-5
    D.3.9.3Other descriptive nameECHINACEA PURPUREA
    D.3.9.4EV Substance CodeSUB13659MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNACONITUM NAPELLUS
    D.3.9.1CAS number 8001003-18-7
    D.3.9.3Other descriptive nameACONITUM NAPELLUS DIL. D6
    D.3.9.4EV Substance CodeSUB12737MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.75
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCAPSICUM ANNUUM
    D.3.9.1CAS number 8001000-51-9
    D.3.9.3Other descriptive nameCAPSICUM ANNUUM DIL. D4
    D.3.9.4EV Substance CodeSUB13232MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.75
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCHAMOMILLA RECUTITA
    D.3.9.3Other descriptive nameCHAMOMILLA RECUTITA
    D.3.9.4EV Substance CodeSUB29812
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHydragyrum bicyanatum
    D.3.9.3Other descriptive nameHydragyrum bicyanatum D6
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.75
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHYDRASTIS CANADENSIS
    D.3.9.1CAS number 8000054-76-4
    D.3.9.3Other descriptive nameHYDRASTIS CANADENSIS DIL. D4
    D.3.9.4EV Substance CodeSUB14129MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.75
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIodum
    D.3.9.3Other descriptive nameIodum dil. D4
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.75
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNatrium tetraboracicum
    D.3.9.3Other descriptive nameNatrium tetraboracicum dil. D4
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.75
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSAMBUCUS NIGRA
    D.3.9.3Other descriptive nameSAMBUCUS NIGRA
    D.3.9.4EV Substance CodeSUB29837
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSANGUINARIA
    D.3.9.1CAS number 8500011-97-4
    D.3.9.3Other descriptive nameSANGUINARIA
    D.3.9.4EV Substance CodeSUB15191MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.75
    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 Yes
    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 placeboOral drops, solution
    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
    recurrent acute otitis media
    rezidivierende akute Mittelohrentzündung
    E.1.1.1Medical condition in easily understood language
    repeated middle ear infections
    wiederholte Entzündungen des Mittelohres
    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 16.1
    E.1.2Level PT
    E.1.2Classification code 10033078
    E.1.2Term Otitis media
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10033079
    E.1.2Term Otitis media acute
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To prove the superiority of Otovowen to placebo in the prevention of acute otitis media
    E.2.2Secondary objectives of the trial
    1. To investigate that Otovowen is superior to placebo in reducing URI and URI-related doctor visits.
    2. To investigate pharmacoeconomic aspects of Otovowen
    3. To investigate whether Otovowen is well tolerated and effective as assessed by parents/legal representative(s).
    4. To assess safety of Otovowen treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Children aged 12 to 59 months
    2. Children with at least 3 episodes of acute otitis media (AOM) since October 1st, 2012 as documented in their medical records. Diagnosis criteria for AOM see study protocol.
    3. Written informed consent
    E.4Principal exclusion criteria
    1. Ongoing acute otitis media or URI
    2. Current prophylaxis/treatment for URI or AOM
    3. Current use of phytotherapeutic and homeopathic agents with secretolytic, anti-inflammatory or immune enhancing properties
    4. Use of tympanostomy tubes
    5. Chronic tympanic membrane perforation (TMP)
    6. Palatine cleft
    7. Parents/legal representative(s) of children unable to follow study procedures, who have no internet access and are not willing to use an online diary on a weekly basis
    8. History of hypersensitivity to the investigational drug or to its ingredients.
    9. Systemic, severe as well as history of uncontrolled chronic disease or a concurrent clinically significant illness, or medical condition, which in the investigator’s opinion, would contraindicate study participation or compliance with protocol mandated procedures.
    10. Simultaneous participation in another clinical trial or participation in any clinical trial involving an investigational medicinal product within 30 days prior to written informed consent for this trial.
    E.5 End points
    E.5.1Primary end point(s)
    To determine the number of AOM episodes diagnosed by a physician within 6 months after enrolment per patient. The difference in the mean number of AOMs per patient comparing both parallel groups will be used for testing the hypothesis of superiority of Otovowen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the individual 6 months observational period
    E.5.2Secondary end point(s)
    - Total number of AOM per treatment group
    - Number of visits due to AOM
    - Number of AOM treated with antibiotics
    - Number of visits due to URI
    - Number of URI treated with antibiotics
    - Number of days with URI
    - Subjective evaluation of efficacy by parent
    - Subjective evaluation of tolerability by parent
    - Adverse events
    - Use of antipyretic, analgesic and antibiotic medication
    - Number of absent days from daycare (patient) / work (parent)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the individual 6 months observational period
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) 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
    LPLV
    LPLV
    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
    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: 296
    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.1.1.4.1Number of subjects for this age range: 148
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 148
    F.1.1.6Adolescents (12-17 years) No
    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 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 of 12-59 months of age
    Kinder im Alter von 12-59 Monaten
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state296
    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)
    standard of care
    Standardbehandlung
    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 Decision2012-08-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-01
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