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    Summary
    EudraCT Number:2011-001776-19
    Sponsor's Protocol Code Number:2010-19
    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:2011-07-04
    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 number2011-001776-19
    A.3Full title of the trial
    MULTICENTRIC RANDOMIZED PLACEBO-CONTROLLED DOUBLE-BLIND 2-ARM PIVOTAL STUDY ON EFFICACY AND SAFETY OF ARHAMA®-TINKTUR N IN PATIENS WITH ACUTE DIARRHEA
    MULTIZENTRISCHE, RANDOMISIERTE, PLAZEBO-KONTROLLIERTE, DOPPEL-BLINDE 2-ARMIGE PIVOTALE STUDIE ZUM NACHWEIS DER WIRKSAMKEIT UND SICHERHEIT VON ARHAMA®-TINKTUR N BEI PATIENTEN MIT AKUTER DIARRHOE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on efficacy and safety of Arhama®-Tinktur N in patients with acute diarrhea
    A.4.1Sponsor's protocol code number2010-19
    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 SponsorBombastus-Werke AG
    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 supportBombastus-Werke AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCardioSec Clinical Research GmbH
    B.5.2Functional name of contact pointProject manager
    B.5.3 Address:
    B.5.3.1Street AddressPeterstr. 5
    B.5.3.2Town/ cityErfurt
    B.5.3.3Post code99084
    B.5.3.4CountryGermany
    B.5.4Telephone number004936178919740
    B.5.5Fax number004936178919744
    B.5.6E-mailinfo@cardiosec.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 Arhama-Tinktur N
    D.2.1.1.2Name of the Marketing Authorisation holderBombastus-Werke AG
    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 nameArhama-Tinktur N
    D.3.2Product code A185
    D.3.4Pharmaceutical form Oral 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.3.9.1CAS number 8022-56-8
    D.3.9.3Other descriptive nameSALVIA OFFICINALIS
    D.3.9.4EV Substance CodeSUB15186MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number19.4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 8000035-12-3
    D.3.9.3Other descriptive nameCITRULLUS COLOCYNTHIS
    D.3.9.4EV Substance CodeSUB13386MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.9
    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 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 placeboOral 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
    Acute unspecific diarrhea
    Akute, unspezifische Diarrhoe
    E.1.1.1Medical condition in easily understood language
    Acute unspecific diarrhea
    Akuter, unspezifischer Durchfall
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10000706
    E.1.2Term Acute diarrhea
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Superiority of oral treatment with Arhama®-Tinktur N (7,5 ml oral per 48 hours) compared to placebo
    E.2.2Secondary objectives of the trial
    Safety and Tolerability of Arhama®-Tinktur N
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Acute, uncomplicated diarrhea as a consequence of gastroenteritis
    Men and women from 18 –70 years




    E.4Principal exclusion criteria
    Hemorrhagic diarrhea with severe general symptoms and high fever
    Bad general condition (apathy, middle to strong exsiccosis)
    Patients with indication of standardised rehydratation or antibiotic use at screening visit
    Duration of diarrhea symtoms longer than 48 hours
    Suspicion of an exacerbation of a known chronic inflammatory bowel disease
    Suspicion of intestinal cancer
    Intake of anti-diarrheal agents during the last 8 hours before randomisation
    Suspicion of parasitical diarrhea
    Suspicion of hormonal induced diarrhea
    Severe systemic diseases (e.g. carcinoma)
    Patients with other severe organic or systemic diseases (e.g. HIV, multiple sclerosis)
    Patients with severe psychiatric diseases (e.g. major depression, schizophrenic disorder)
    Pregnancy and nursing
    Women with child-bearing potential without safe contraception
    E.5 End points
    E.5.1Primary end point(s)
    Duration of diarrhea (time form start of medication to last unformed stool)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Maximum duration of 14 days
    E.5.2Secondary end point(s)
    Total duration of disease (time form first unformed stool to last unformed stool)
    Responder rate regarding symptoms of diarrhea
    Responder rate regarding healed patients (no diluted and =<2 unformed stools in the last 24 hours in comparison to 24 hours before randomisation)
    Rate of patients with aggravation of symptoms at day 2
    Rate of patients with persisting symptoms at day 14
    Rate of patients with need of standardised rehydratation or antibiotic treatment
    Change of abdominal pain and/or cramps
    Change of stool frequency
    Assessment of treatment success by the investigator
    Frequency and severity of adverse events
    Acceptance of study medication by the patient
    Asseessment of tolarability by the investigator
    Change of standard laboratory parameters
    Change of immunological lab parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    Maximum of 14 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 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 concerned20
    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
    database 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 months6
    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 months6
    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 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: 420
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state470
    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 after the subject has ended his participation in the trial will be done by subject's general practitioner.
    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 Decision2011-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-09-05
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