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    The EU Clinical Trials Register currently displays   42869   clinical trials with a EudraCT protocol, of which   7063   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-001430-34
    Sponsor's Protocol Code Number:10-TT-EP-003
    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:2012-05-04
    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 number2012-001430-34
    A.3Full title of the trial
    Therapeutic effectiveness, safety and tolerability of Tonsilotren tablets
    in patients (6 to 60 years old) with chronic tonsillitis.
    A randomized, international, multicenter, controlled clinical trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Therapeutic effectiveness, safety and tolerability of Tonsilotren tablets
    in patients (6 to 60 years old) with chronic inflammation of palatine tonsils.
    A randomized, international, multicenter, controlled clinical trial.
    A.3.2Name or abbreviated title of the trial where available
    TocTo (Tonsilotren in chronic Tonsillitis)
    A.4.1Sponsor's protocol code number10-TT-EP-003
    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 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 supportDeutsche Homöopathie-Union, DHU-Arzneimittel GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDeutsche Homöopathie-Union, DHU-Arzneimittel GmbH & Co. KG
    B.5.2Functional name of contact pointMedical Affairs & Clinical Research
    B.5.3 Address:
    B.5.3.1Street AddressOttostr. 24
    B.5.3.2Town/ cityKarlsruhe
    B.5.3.3Post code76227
    B.5.3.4CountryGermany
    B.5.4Telephone number00490721409301
    B.5.5Fax number0049072140938781
    B.5.6E-mailsabine.dejaegere@dhu.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 Yes
    D.2.1.1.1Trade name Tonsiotren H (Tabletten)
    D.2.1.1.2Name of the Marketing Authorisation holderDeutsche Homöopathie-Union, DHU-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.3.4Pharmaceutical form Tablet
    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 INNAtropinum sulfuricum trit. D5
    D.3.9.2Current sponsor codeAtropinum sulfuricum trit. D5
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHepar sulfuris trit. D3
    D.3.9.2Current sponsor codeHepar sulfuris trit. D3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10.00
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNKalium bichromicum trit. D4
    D.3.9.2Current sponsor codeKalium bichromicum trit. D4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50.00
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSilicea trit. D2
    D.3.9.2Current sponsor codeSilicea trit. D2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.00
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMercurius bijodatus trit. D8
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25.00
    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 Yes
    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
    Chronic tonsillitis
    E.1.1.1Medical condition in easily understood language
    Chronic inflammation of palatine tonsils
    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 PT
    E.1.2Classification code 10009152
    E.1.2Term Chronic tonsillitis
    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
    The primary objective of the study is to assess the therapeutic effectiveness of Tonsilotren in the treatment of chronic tonsillitis when used in addition to conventional symptomatic treatment (test group) in comparison to conventional symptomatic treatment alone (control group).
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to assess safety and tolerability of Tonsilotren treatment in chronic tonsillitis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females aged from 6 to 60 years;
    2. Diagnosed chronic tonsillitis characterized by:
    - the presence of at least three of five local symptoms at visit 1:
    o Hyperemia of the anterior palatine arches;
    o Edema of angle where the anterior and posterior palatine arches join each other;
    o Caseous purulent plug and / or purulent exudates in the tonsillar crypts;
    o Friable tonsils or indurated tonsils or scarred adhesions between the tonsils and the palatine arches;
    o Enlarged submandibular lymph nodes.
    - At least three acute throat infections within the past twelve months, or two acute throat infections during each of the two last years, documented in the patient file;
    Definition and criteria for accepted documentation of acute throat infection in the patient file: Diagnoses and / or corresponding codes J02 and J03 according to WHO ICD-10. Also documentation in referral letters is accepted. If exact number of events is not given, information (date and diagnosis of each event) should be obtained by contact with referral person and documented.
    3. Signed informed consent according to the applicable law;
    4. Willingness and ability to comply with all procedures of the trial.
    E.4Principal exclusion criteria
    1. Presence of acute throat infection at inclusion;
    2. Presence of peri-tonsillar abscess;
    3. Presence of acute and chronic otitis, adenoiditis, sinusitis of all types, odontological infection, bronchial and lung disease (e.g. bronchitis, bronchial asthma, cystic fibrosis), tuberculosis or known allergic manifestations in the throat and / or mouth;
    4. Obstruction in the pharynx due to enlargement of tonsils (causing severe sleep disorders e.g. sleep apnea);
    5. Presence of severe cardiovascular, renal or hepatic disease, as well as gastroesophageal reflux, unstable diabetes mellitus, hyperthyroidism, cerebrovascular or other active bleeding, Human Immunodeficiency Virus (HIV) infection, mononucleosis of each severity, or oropharyngeal gonorrhea;
    6. History of non-steroidal anti-inflammatory drugs (NSAIDs) intolerance (e.g. bronchospasm, asthma, rhinitis, urticaria, gastrointestinal bleeding or perforation), hematogenetic dysfunction of unknown origin, repeated peptic ulcera or hemorrhages;
    7. History or presence of all kind of serious streptococcal complications (rheumatic heart disease, glomerulonephritis, joint pain, arthritis);
    8. Previous surgery in the past six months or need for surgery of the nose or paranasal sinuses, adenoids and / or tonsils;
    9. Evidence of any malignant disease during the past five years before enrolment into the trial;
    10. Presence of neurological and / or psychiatric diseases (e.g. depressive episode) interfering with evaluation of quality of life and assessment in the patient's diary;
    11. Treatment with systemic acting antibiotics, glucocorticosteroids or medications with immunomodulating activities during the past four weeks and treatment with NSAIDs as well as locally on the tonsils acting antibiotics, glucocorticosteroids or immunomodulators during the past week prior to enrolment into the trial;
    12. Known or suspected hypersensitivity to chromium, mercury or any other ingredient and / or excipient of Tonsilotren as well as lactose and / or fructose intolerance and known intolerance towards leather and jewelry metals as well as towards dental metal fillings and vaccines;
    13. Heavy smoking (>= 20 cigarettes per day) or known or suspicion to or presence of drug addiction including alcohol abuse;
    14. Women of childbearing potential without adequate contraception or women, who want to become pregnant, are pregnant or breast-feeding;
    15. Prior enrolment into this trial;
    16. Participation in another clinical trial during the past three months prior to enrolment into the trial;
    17. Incapability of understanding nature, meaning and consequences of the trial;
    18. Patients in custody by juridical or official order;
    19. Patients, who are members of the staff of the study center, staff of the sponsor or involved Clinical Research Organizations (CROs), the investigator him- / herself or close relatives of the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    1. Mean period of time between consecutive acute throat infections within one year.

    An acute throat infection must be confirmed by the investigator. It is defined by the presence of fever (axillary temperature >= 37.5°C), throat hyperemia (e.g. pharynx, tonsils, etc.) and difficulty in swallowing / sore throat.
    Patients are instructed to visit their investigator for an additional visit in case they feel sick with acute complaints in the upper respiratory tract. Investigators are requested to document primary diagnosis. Acute throat infections are limited to all diagnoses in accordance with codes J02 and J03 of WHO ICD-10 (e.g. acute pharyngitis, acute tonsillitis, adenotonsillitis, or tonsillopharyngitis) and may be of viral or bacterial origin.
    Relapses of acute throat infection within 7 days after end of its treatment belong to the originating acute throat infection and do not count separately.
    Time between two acute throat infections will be calculated using first day of infection as reference point.
    Evaluation year is defined as period between visit 3 (week 8) and visit 9 (week 60). Withdrawals until visit 3 will be replaced.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 9 (week 60).
    E.5.2Secondary end point(s)
    2. Number of days with either sore throat / difficulties in swallowing or halitosis or exhaustion (infection-related complaints e.g. fatigue, weakness, sleeping disorders, decreased appetite, lack of concentration or decreased productivity) on the basis of patient diary in each single treatment period and each follow-up period;
    3. Number of URTIs within one year ;
    4. Severity of chronic tonsillitis symptoms as evaluated by the investigator at each regular study visit ;
    5. Frequency of antibiotics consumption due to acute throat infections;
    6. Days with analgetics consumption due to acute throat infections;
    7. Effect of treatment on performance of normal daily activity in each single treatment and each follow-up period based on the information given in the patient's diary;
    8. Patient's quality of life using a 5-item rating scale (very good, good, moderate, poor, very poor) at each regular visit except visit 2;
    9. Treatment outcome according to Integrative Medicine Outcome Scale (IMOS) at each post-baseline study visit except visit 2;
    10. Tolerability of treatment at the end of each study treatment period (evaluation in test group only);
    11. Adverse events including incidence of tonsillitis’ complications (rheumatic fever, rheumatic heart disease, glomerulonephritis, arthritis).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to each individual endpoint, see section E.5.2.
    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) 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 patients: conventional symptomatic treatment, test group additionally Tonsilotren.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Conventional symptomatic treatment
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Ukraine
    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
    Time point of study data base closure.
    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 months11
    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 months11
    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: 160
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 80
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 80
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 80
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children / adolescents between 6 and 17 years of age will be enrolled, but not in Germany.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 240
    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)
    Plan for treatment of subject after end of participation is not different from expected normal treatment of chronic tonsillitis.
    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 Decision2012-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-08-14
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