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    Summary
    EudraCT Number:2004-005095-17
    Sponsor's Protocol Code Number:EA041999
    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:2005-01-05
    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 number2004-005095-17
    A.3Full title of the trial
    Randomised, double-blind, placebo-controlled, monocentric phase III study on the efficacy and safety of Lidocaine 8 mg Sore Throat Lozenges in patients with moderate to severe acute sore throat not necessarily to be treated with antibiotics
    A.3.2Name or abbreviated title of the trial where available
    Lidocaine 8 mg sore throat lozenges vs. placebo
    A.4.1Sponsor's protocol code numberEA041999
    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 SponsorEngelhard 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 Information not present in EudraCT
    D.2.1.1.1Trade name Trachisan® Halsschmerztabletten
    D.2.1.1.2Name of the Marketing Authorisation holderEngelhard Arzneimittel 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.3.1Product nameLidocain 8 mg Halsschmerztabletten
    D.3.4Pharmaceutical form Lozenge
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlidocaine
    D.3.9.1CAS number 137-58-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0 to 8
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 placeboLozenge
    D.8.4Route of administration of the placeboOromucosal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The study will be performed in patients suffering from acute sore throat not necessarily to be treated with antibiotics
    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
    Evaluation of efficacy and safety of 8 mg lidocaine sore throat lozenges for the treatment of acute sore throat not necessarily to be treated with antibiotics compared to placebo.

    primary variable (AUC0h-2h of PID) will be analysed confirmatorily by a 2-sided t-test (at level 5%). A 2-sided confidence interval (95%) will be calculated for the difference (verum – placebo) of AUC of PID. In addition, all these analyses will be conducted for the PP population as sensitivity analysis.
    E.2.2Secondary objectives of the trial
    secondary variables (PI related variables) will be described for the ITT population.
    global assessments of efficacy will be described by frequencies and percentages (related to number of patients with information) for the ITT population, "very good" / "good" will be combined.
    number of needed study medication will be described by frequencies for the ITT population.
    safety variables (safety population):
    adverse events will be coded according to MedDRA and evaluated on preferred term and system organ class level with regard to intensity, drug relationship and seriousness
    global assessments of tolerability will be described by frequencies and percentages (related to number of patients with information), "very good" / "good" will be combined
    vital signs will be analysed for each time point as well as for the difference to baseline
    oro-pharyngeal variables
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Patients of both genders will be enrolled. They must fulfil all the following criteria before being enrolled in the study:
    - Age: > 18 years.
    - Patients with moderate to severe throat pain (³60 mm VAS) due to acute
    pharyngitis of recent onset (within preceding 48 hours) not requiring antibiotic
    treatment.
    - The patient must give written informed consent, after having been informed about
    benefits and potential risks of the trial, as well details of the insurance taken out to
    cover the subjects participating in the study.
    E.4Principal exclusion criteria
    Patients are to be excluded from the study if they display any of the following criteria:
    - Hypersensitivity to lidocaine hydrochloride, local anaesthetics of the amide type or
    any of the excipients of the study drugs.
    - Known or suspected primary or secondary bacterial pharyngitis or
    tonsillopharyngitis (e.g. clinical finding of purulent, serous or fibrinous exudate from
    the pharyngeal mucosa).
    - Known or suspected oro-pharyngeal mycosis.
    - Presence of severely traumatised and / or very severe inflammation of the oro
    -pharyngeal mucosa.
    - Severe lower respiratory tract infection (pneumonia, bronchitis) requiring antibiotic
    treatment.
    - Acute rhino-sinusitis or laryngitis requiring antibiotic treatment.
    - Fever (>38°C oral).
    - Systemic treatment with analgesics (within the last 12 hours) or non-steroidal anti
    -inflammatory drugs, COX-2 inhibitors (within the last 24 hours) prior to enrolment
    except long-term treatment with low-dose ASA (£ 100 mg ASA per day).
    - Treatment with codeine containing cough preparations within the last 12 hours
    prior to enrolment.
    - Topical oro- or nasopharyngeal use of local anaesthetics and / or antiseptic
    formulations (such as lozenges, pharyngeal washes, breath spray, inhalation) or
    use of herbal teas used for the treatment of common cold within the last 6 hours
    prior to enrolment.
    - Concomitant systemic propranolol treatment.
    - Concomitant systemic cimetidine treatment unless the treatment will be interrupted
    the latest 6 hours prior to first intended lidocaine treatment.
    - Systemic or topical (oro-pharyngeal) treatment with an antibiotic agent within the
    last week prior to enrolment.
    - Known fructose intolerance.
    - Known medical condition associated with chronic pain, clinically relevant acute
    disease (at the investigator’s judgement), known current haematopoietic or
    malignant disorder.
    - Presence of relevant neurological or psychiatric disorder or mental impairment.
    - Pregnancy or breast feeding.
    - Women of childbearing potential unable or unwilling to practice adequate
    contraceptive measures.
    - Heavy smoker (³ 20 cigarettes per day).
    - Suspicion of alcohol abuse, drug addiction or any other condition of the patient that
    at the investigator’s discretion may jeopardise patient’s compliance or adherence
    to protocol requirements.
    - Previous participation in this study or participation in any other drug investigational
    trial within the preceding 30 days.
    - Volunteers suspected or known not to follow the instructions.
    The exclusion criteria are chosen to assure that patients with specific risks for administration of the investigated drug and patients with conditions which may have an impact on efficacy parameters are excluded.
    E.5 End points
    E.5.1Primary end point(s)
    not applicable
    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 Information not present in EudraCT
    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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 years
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    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 Information not present in EudraCT
    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 2005-01-05. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state370
    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)
    In case a worsening of symptoms occurs or in case there still are symptoms to be treated after the end of the trial, on the discretion of the patient an intensiv costfree therapy (e.g. antibiotics or additional analgetics) may be initiated. However, transfer to the family doctor will also be possible.
    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 Decision2005-02-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-02-10
    P. End of Trial
    P.End of Trial StatusCompleted
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