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    Summary
    EudraCT Number:2012-002876-15
    Sponsor's Protocol Code Number:MCMK0112
    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:2012-08-09
    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 number2012-002876-15
    A.3Full title of the trial
    A randomised, multi-centre, parallel group, double-blind, placebo- and active-controlled clinical study to assess the efficacy and safety of Octenidine lozenges in the treatment of acute sore throat.
    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 Octenidine lozenges in the treatment of acute sore throat. Octenedine Lozenges will be compared with an active comparator and against placebo in patients at multiple sites, in a double blind ( patient and doctor) randomised manner.
    A.4.1Sponsor's protocol code numberMCMK0112
    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 SponsorCassella-med 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 supportCassella-med GmbH & Co KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCassella-med GmbH & Co KG
    B.5.2Functional name of contact pointDr Christian Nauert
    B.5.3 Address:
    B.5.3.1Street AddressGereonsmühlengasse 1-11
    B.5.3.2Town/ cityKöln
    B.5.3.3Post code50670
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 221 1652 0
    B.5.5Fax number+49 221 1652 430
    B.5.6E-mailchristian.nauert@Klosterfrau.de
    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 No
    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 nameOctenidine lozenges
    D.3.4Pharmaceutical form Lozenge
    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 INNOctenidine hydrochloride
    D.3.9.1CAS number 70775-75-6
    D.3.9.4EV Substance CodeSUB03484MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2.5 to 2.7
    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.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 Neo-angin Sugar Free Lozenges
    D.2.1.1.2Name of the Marketing Authorisation holderKlosterfrau 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.3.1Product nameNeo-angin sugar free
    D.3.4Pharmaceutical form Lozenge
    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 INN2,4 Dichlorobenzyl alcohol
    D.3.9.1CAS number 1777-82-8
    D.3.9.3Other descriptive nameDICHLOROBENZYL ALCOHOL
    D.3.9.4EV Substance CodeSUB13566MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1.14 to 1.26
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAmylmetacresol
    D.3.9.1CAS number 53043-14-4
    D.3.9.3Other descriptive nameAMYLMETACRESOL
    D.3.9.4EV Substance CodeSUB05497MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.57 to 0.63
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLevomenthol
    D.3.9.1CAS number 2216-51-5
    D.3.9.3Other descriptive nameLEVOMENTHOL
    D.3.9.4EV Substance CodeSUB08475MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5.67 to 6.27
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboLozenge
    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
    Acute pharyngitis
    E.1.1.1Medical condition in easily understood language
    Sore throat
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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
    The primary objectives are to demonstrate superiority of Octenidine lozenges compared with placebo in terms of rate of responders, and to demonstrate non-inferiority of Octenidine lozenges compared with active comparator (neo angin®) in terms of the rate of responders.
    Response is defined as a score of 4 or 5 on the Pain Relief Rating Scale (PRRS) (patient assessment) at visit 3 (study day 3 or 4, LOCF) and a total score of 0 or 1 on the Tonsillo-Pharyngitis Score (TPS) (investigator assessment) at visit 3 (study day 3 or 4, LOCF).
    Both primary objectives are efficacy objectives
    E.2.2Secondary objectives of the trial
    Secondary efficacy objective is to compare Octenidine, matching placebo and active comparator in terms of:
    -Pain Relief Rating Scale (PRRS): rate of patients with pain relief at visits 2 and 3 and at study day 2
    -Tonsillo-Pharyngitis Score (TPS): rate of patients with improvement at visit 2 and visit 3
    -Tonsillo-Pharyngitis Score (TPS): mean change from baseline at visit 2 and visit 3
    - Visual Analogue Scales (VAS): mean change from baseline at visit 2 and visit 3

    The other secondary (safety)
    objective is to compare Octenidine, matching placebo and active comparator in terms of
    - adverse events
    - local adverse reactions according to pre-specified list
    - results of the physical examination
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age between 12 and 65 years, signed informed consent
    -Sore throat for a maximum of 36 hours, short-term adjuvant treatment indicated.
    -Inflammation of the mucosa of the mouth and throat with typical symptoms like pain, reddening and swelling, to be verified by the investigator by means of:
    - a physical examination
    - a Tonsillo-Pharyngitis Score >2
    -Pain on two 10 cm visual analogue scales (VAS) (pain at rest and pain when swallowing) at day 0 of at least 10 cm (sum of both VAS). At least 4 cm on each of both VAS.
    - On-site test for streptococcus negative
    E.4Principal exclusion criteria
    -Fever>38°C and/or multiple swollen anterior lymph nodes
    - Fever>38°C and/or multiple swollen anterior lymph nodes
    - Purulent tonsillitis and/or rash according to the investigator's clinical judgement
    - Treatment with systemic antibiotics within the last 7 days
    - Treatment with any antiseptics, analgesics, local anaesthetics, ambroxol, bromhexin or codeine within the last 12 hours
    - Actual need for treatment with systemic antibiotics
    - Allergy to Octenidine or ingredients of neo-angin® (Levomenthol, 2,4-Dichlorbenzylalcohol, Amylmethacresol, Peppermint Oil, Glucose or Sucrose)
    - Present gastrointestinal diseases or gastrointestinal diseases in the anamnesis which may be regarded as pre-disposition for adverse effects of orally administered antiseptics, e.g. gastrointestinal diseases associated with diarrhoeas and/or imbalances of the microbiological colonisation of the gastrointestinal tract
    - Diabetes, malignomas, severe infections like hepatitis A, B, C, HIV, tuberculosis
    - Other diagnoses that could interfere with the study diagnosis or therapy
    - Immunosuppressive therapy within 2 months prior to study start or during study
    - Addiction to alcohol or drugs
    - Pregnancy or lactation
    - Participation in a further clinical trial at the same time or within the last 4 weeks prior to inclusion into the present study.
    All exclusion criteria referring to clinical aspects are to be verified by the investigator during a physical examination.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is a combination of pain relief (assessed by the patient) and reduction of inflammation (assessed clinically by the investigator)
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 days
    E.5.2Secondary end point(s)
    -
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 days
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 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
    End of trial is defined as the last study visit of the last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    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: 85
    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: 85
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 615
    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 state700
    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 Decision2012-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-01
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