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    Summary
    EudraCT Number:2021-002214-14
    Sponsor's Protocol Code Number:IHO-0000-REN-0220-S
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-09-15
    Trial 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 number2021-002214-14
    A.3Full title of the trial
    Individualized homeopathy to reduce the use of antibiotics in women with recurring uncomplicated urinary tract infections
    Individualisierte homöopathische Behandlung zur Reduktion des Antibiotikabedarfs bei Patientinnen mit rezidivierenden Harnwegsinfekten
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Individualized homeopathy to reduce the use of antibiotics in women with recurring uncomplicated urinary tract infections
    Individualisierte homöopathische Behandlung zur Reduktion des Antibiotikabedarfs bei Patientinnen mit rezidivierenden Harnwegsinfekten
    A.3.2Name or abbreviated title of the trial where available
    iHOM
    A.4.1Sponsor's protocol code numberIHO-0000-REN-0220-S
    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 SponsorKlinikum rechts der Isar, Technische Universität München
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBayerisches Landesamt für Gesundheit und Lebensmittelsicherheit
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKlinikum rechts der Isar, Technische Universität München, Abteilung für Nephrologie
    B.5.2Functional name of contact pointProf. Dr. med. Lutz Renders
    B.5.3 Address:
    B.5.3.1Street AddressIsmaningerstr. 22
    B.5.3.2Town/ cityMünchen
    B.5.3.3Post code81675
    B.5.3.4CountryGermany
    B.5.4Telephone number+498941405049
    B.5.5Fax number+498941407734
    B.5.6E-mailLutz.Renders@tum.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 homeopathic medical products
    D.2.1.1.2Name of the Marketing Authorisation holderGudions GMBH Dr. (Univ. Urbino) Hannes Proeller, Friedrich-Merz-Straße 5 86153 Augsburg
    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 Pillules in single-dose container
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 No
    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 placeboPillules in single-dose container
    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
    Women with recurring uncomplicated urinary tract infections
    Frauen mit wiederkehrenden Harnwegsinfekte
    E.1.1.1Medical condition in easily understood language
    Women with recurring uncomplicated urinary tract infections
    Fauen mit wiederkehrenden Harnwegsinfekte
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10021872
    E.1.2Term Infection urinary tract
    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
    Primary Objective: To investigate the efficacy of prophylactic individualised homeopathic treatment (potency C200 and/or C1000), as a therapeutic principle, in comparison to placebo regarding the number of UTI treated with antibiotic agents.

    Primäres Ziel: Untersuchung der Wirksamkeit einer individualisierten homöopathischen Behandlung (Potenz C200 und / oder C1000) im Vergleich zu Placebo hinsichtlich der Anzahl der mit Antibiotika behandelten HWI.
    E.2.2Secondary objectives of the trial
    Seconary Objectives:To investigate the efficacy of individualised homeopathic treatment (potency C200 and/or C1000) in comparison to placebo regarding the number of UTI.
    To investigate the efficacy of individualised homeopathic treatment (potency C200 and/or C1000) in comparison to placebo regarding the disease-specific quality of life.
    Sekundäres Ziel: Untersuchung der Wirksamkeit einer individualisierten homöopathischen Behandlung (Potenz C200 und / oder C1000) im Vergleich zu Placebo hinsichtlich der Anzahl der HWI (ungeachtet der erfolgten Behandlung).
    Untersuchung der Wirksamkeit einer individualisierten homöopathischen Behandlung (Potenz C200 und / oder C1000) im Vergleich zu Placebo hinsichtlich der krankheitsspezifischen Lebensqualität
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Females, age 18< 65 years
    2.Signed informed consent
    3.Documented recurrent UTI (i.e. ≥ 2 UTI in 6 months and/ or ≥ 3 UTI in 12 months)
    4.No change of other prophylactic treatment (e.g. Urovaxom, estrogen) for recurrent UTI for at least three months before baseline
    5.No product or dosage change of systemic hormonal treatment (including oral anticonception) for at least three months before baseline
    6.Female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country.

    1.Frauen im Alter von 18 bis < 65 Jahren
    2.Unterzeichnete Einverständniserklärung
    3.Dokumentierte rezidivierende unkomplizierte HWI (≥ 2 HWI in 6 Monaten und / oder ≥ 3 HWI in 12 Monaten)
    4.Mindestens drei Monate lang keine Änderung einer anderen prophylaktischen Behandlung für rezidivierende HWI (z. B. Urovaxom, Östrogen)
    5.Mindestens drei Monate lang keine Produkt- oder Dosierungsänderung einer systemischen Hormontherapie (einschließlich oraler Antikonzeption)
    6.Teilnehmerinnen, die keine Kinder gebären können oder eine Verhütungsmethode anwenden, die von der Gesundheitsbehörde des jeweiligen Landes medizinisch zugelassen ist
    E.4Principal exclusion criteria
    .Individual symptomatology of the patient indicates the prescription of
    a HMP which is not available within this clinical trial
    2.Pregnancy or breast feeding after pregnancy
    3.Women with a complicated urinary tract infection (including infections
    occurring due to anatomical abnormalities (e.g. an obstruction, renal
    tract calculi, hydro nephrosis), infections occurring due to an immune
    compromised state (e.g. HIV, immune suppressive therapy), and
    recurrent infections despite adequate treatment (multi-drug resistant
    organisms or atypical organisms))
    4.Surgery of the urinary tract or the pelvic floor
    5.Known hypersensivity against the study medication or the
    recommended on demand medication (Ibuprofen)
    6.Homoeopathic therapy for recurrent UTIs during the last 6 months
    before baseline
    7.Postmenopausal woman WITHOUT previous attempt of a therapy
    with locally applicate (vaginal) oestrogen
    8.Serious acute or chronic organic disease or serious mental disorder,
    including
    -diseases requiring immune suppressive therapy
    -diabetes mellitus type 1 or 2 with an HbA1c > 7%
    -any acute organic failure
    -any advanced chronic organic failure (e.g. grade 3 or more)
    -active cancer
    -active (=clinically unstable) epileptic, cardiovascular or other organic
    pathology
    9.Patients not able to declare meaningful informed consent on their own
    (e.g. with legal guardian), or other vulnerable patients (e.g. under
    arrest)
    10.Simultaneous participation in any other clinical trial
    11.Employees or family members of the sponsor or investigators
    1.Für die individuelle Symptomatik des Patienten ist die Verschreibung
    eines HMP indiziert, das in dieser klinischen Studie nicht verfügbar ist
    2.Schwangerschaft oder Stillzeit
    3.Frauen mit einer komplizierten Harnwegsinfektion (einschließlich
    Infektionen aufgrund anatomischer Anomalien (z. B. Obstruktion,
    Nierensteine, Hydro-Nephrose), Infektionen aufgrund eines
    immungeschwächten Zustands (z. B. HIV, immunsuppressive Therapie)
    und wiederkehrende Infektionen trotz angemessener Behandlung
    (multiresistente Organismen oder atypische Organismen))
    4.Stattgehabte Operation der Harnwege oder des Beckenbodens
    5.Bekannte Überempfindlichkeit gegen die HMPs oder die empfohlene
    Bedarfsmedikation (Ibuprofen und / oder Fosfomycin)
    6.Homöopathische Therapie für rezidivierende HWI in den letzten 6
    Monaten vor Aufnahme in die Studie
    7.Frauen nach der Menopause OHNE vorangegangenem Versuch einer
    Therapie mit vaginal angewendeten östrogenhaltigen Produkten
    8.Schwere akute oder chronische organische Erkrankung oder schwere
    psychische Störung, einschließlich:
    -Krankheiten, die eine immunsuppressive Therapie erfordern
    -Diabetes mellitus Typ 1 oder 2 mit einem HbA1c-Wert > 7% jede akute
    organische Störung
    -fortgeschrittenes chronisches organisches Versagen (z. B. Grad 3 oder
    mehr)
    -aktiver Krebs
    -aktive (=klinisch instabile) epileptische, kardiovaskuläre oder andere
    organischePathologien
    9.Patienten, die nicht in der Lage sind, selbst eine aussagekräftige
    Einverständniserklärung abzugeben (z. B. mit Erziehungsberechtigten),
    oder andere schutzbedürftige Patienten (z. B. Gefängnisinsassen)
    10.Gleichzeitige Teilnahme an anderen klinische Prüfung
    11.Mitarbeiter oder Familienangehörige des Sponsors oder der
    Studienärzte
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint:
    To compare the number of UTI treated with antibiotic agents, measured between baseline and month 9 in both groups
    A UTI is defined by the criteria of the German S3-guideline for the diagnostic of uncomplicated lower UTI:
    1.Clinical symptoms (either dysuria or increased urinary frequency or increased incontinence or pelvic pain) plus > 103 bacteria as monoculture in the urine culture, or
    2.Clinical symptoms plus urine test-strip with an evidence of nitrite and / or leukocyte-esterase and/ or blood

    The criteria for a prescription of antibiotic agents to the patient are:
    1.Fever > 38.0 degree Celsius, and / or
    2.Persistent pain under symptomatic therapy with Ibuprofen, not tolerated by the patient, and / or
    3.Clinical suspicion of pyelonephritis
    Primärer Endpunkt:
    Der Vergleich der Anzahl der mit Antibiotika behandelten HWI, gemessen zwischen Baseline und Monat 9 in beiden Gruppen.
    Eine HWI ist nach den Kriterien der deutschen S3-Leitlinie zur Diagnostik der unkomplizierten unteren HWI wie folgt definiert:
    1.Klinische Symptome (entweder Pollakis- oder Dysurie oder Zunahme von Inkontinenz oder Beckenschmerzen) plus > 103 Bakterien als Monokultur in der Urinkultur, oder
    2.Klinische Symptome plus Urinteststreifen mit Anzeichen von Nitrit und / oder Leukozytenesterase und / oder Blut
    Die Kriterien für die Verschreibung von Antibiotika sind:
    1.Fieber > 38,0 Grad Celsius und / oder
    2. Anhaltende Schmerzen unter symptomatischer Therapie mit Ibuprofen, die vom Patienten nicht vertragen werden und / oder
    3. Klinischer Verdacht auf Pyelonephritis
    E.5.1.1Timepoint(s) of evaluation of this end point
    Measured between months 0-9
    Gemessen zwischen dem 0-9 Monat
    E.5.2Secondary end point(s)
    Secondary endpoints (comparisons between groups):
    1.Time until the first UTI after the start of the study treatment (regardless of treatment of the first UTI)
    2.The number of UTI treated symptomatically, measured between Baseline and month 9
    3.Subjective symptom load and disease-specific quality of life over the last 3 months, measured at baseline and at month 9 per visual analogue scale (VAS)

    Sekundäres Ziel: Untersuchung der Wirksamkeit einer individualisierten homöopathischen Behandlung (Potenz C200 und / oder C1000) im Vergleich zu Placebo hinsichtlich der Anzahl der HWI (ungeachtet der erfolgten Behandlung).
    Untersuchung der Wirksamkeit einer individualisierten homöopathischen Behandlung (Potenz C200 und / oder C1000) im Vergleich zu Placebo hinsichtlich der krankheitsspezifischen Lebensqualität
    E.5.2.1Timepoint(s) of evaluation of this end point
    Measured between months 0-9
    Gemessen zwischendem Monat 0-9
    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) No
    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 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 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 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
    LVLS
    LVLS
    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 months
    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 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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 240
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state240
    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)
    Treatment is carried out according to clinical routine.
    Behandlung erfolgt nach klinischer Routine.
    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 Decision2022-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-30
    P. End of Trial
    P.End of Trial StatusOngoing
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