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    Summary
    EudraCT Number:2014-001864-36
    Sponsor's Protocol Code Number:Rikkunshito1
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-07-30
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2014-001864-36
    A.3Full title of the trial
    A PLACEBO-CONTROLLED STUDY ON THE EFFECT OF RIKKUNSHITO ON GASTRIC ACCOMMODATION AND NUTRIENT TOLERANCE, QUANTIFIED BY INTRAGASTRIC PRESSURE MONITORING DURING INTRAGASTRIC NUTRIENT INFUSION, IN FUNCTIONAL DYSPEPSIA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of rikkunshito, a traditional Japanese herbal medicine, on stomach functions of patients with functional dyspepsia
    A.3.2Name or abbreviated title of the trial where available
    Proof-of-Concept of Rikkunshito in Functional Dyspepsia
    A.4.1Sponsor's protocol code numberRikkunshito1
    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 Sponsoruzleuven
    B.1.3.4CountryBelgium
    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 supportUZLeuven
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportTsumura
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUZLeuven
    B.5.2Functional name of contact pointLieselot Holvoet
    B.5.3 Address:
    B.5.3.1Street AddressHerestraat 49
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.4Telephone number3216340750
    B.5.5Fax number3216344318
    B.5.6E-maillieselot.holvoet@uzleuven.be
    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 nameRikkunshito
    D.3.2Product code TJ-43
    D.3.4Pharmaceutical form Powder for oral solution in sachet
    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 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 placeboPowder for oral solution in sachet
    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
    functional dyspepsia - postprandial distress syndrome
    E.1.1.1Medical condition in easily understood language
    Patients who suffer from stomach symptoms like prostprandial fullness, early satiety, slow digestion, nausea or vomiting without a medical cause
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10064536
    E.1.2Term Functional dyspepsia
    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
    to evaluate the effect of Rikkunshito on gastric accommodation in patients with functional dyspepsia, measured by evaluating the IGP during intragastric nutrient infusion
    E.2.2Secondary objectives of the trial
    to explore the changes in FD symptom severity using the Leuven Postprandial Distress Scale (LPDS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At visit 1(Diagnosis before assessment of the activity of the disease by LPDS):

    1. Patients with FD diagnosis as per Rome III

    2. Patients must provide witnessed written informed consent prior to any study procedures being performed

    3. Patients aged between 18 and 75 years inclusive

    4. Male or female patients

    5. Patients who are capable to understand the study and the questionnaires, and to comply with the study requirements


    At visit 2 (Evaluation of the activity of the disease by LPDS before randomisation):

    6. Patients suffering from active PDS (Rome III) as per LPDS scoring system during the 2 weeks eligibility period.
    At least moderate Postprandial fullness and/or early satiation should be present at least 4 days during the 2 weeks eligibility period.
    E.4Principal exclusion criteria
    1. Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study

    2. Patients with an active major psychiatric condition (depression, anxiety disorder, alcohol or substance abuse). However, patients who are taking a stable dose of a single antidepressant (with the exception of amitryptiline and mirtazapin which are forbidden) during the last 3 months are eligible.

    3. Females who are pregnant or lactating. Females who refuse to take appropriate contraception at the time of informed consent.

    4. Men who want to donate sperm during the study and during the 4 weeks after stopping Rikkunshito.

    5. Patients who received treatment for HP eradication during the last 3 months. Patients who are HP positive may enter the study provided that their endoscopy is negative. HP status will be taken at visit 1.

    6. Patients suffering from diabetes type 1 or type 2.

    7. Patients taking drugs affecting the gut secretion, mucosal integrity (NSAIDs with an exception for aspirin at cardioprotective dose of max 125 mg daily), motility, and/or sensitivity. Patients taking PPIs are eligible provided that FD is predominant and heartburn limited to maximum two episodes of mild intensity per week.

    8. Patients with coronary heart disease, arrhythmias or taking concomitant drugs capable to prolong the QT.

    9. Patients taking concomitant drugs able to induce drug-drug interaction (P450).

    10. Patients with a significant renal [serum creatinine >2 x upper limit of normal (ULN)], hepatic [alanine transaminase (ALT), aspartate transaminase (AST), gamma glutamyltransferase (GGT), bilirubin >2 x ULN], cardiovascular, pulmonary, endocrine, metabolic or haematological condition.

    11. Patients with known hypersensitivity to the Ginseng or Ginger.

    12. Patients with confirmed gastro-intestinal disease.

    13. Patients with former digestive surgery affecting upper gut motility.

    14. Patients affected by concomitant extra-digestive disease responsible for digestive symptoms.

    15. Patients presenting with predominant symptoms of irritable bowel syndrome (IBS).

    16. Patients presenting symptoms of EPS several times a week according to Rome III questionnaire (score 5 or higher on question 10).

    17. Patients presenting daily symptoms of CIN on Rome III questionnaire (score 6 on question 6 or score 5 or higher on question 9).

    18. Patients presenting vomiting more than one day a month.

    19. Patients presenting daily symptoms of Excessive belching according to Rome III questionnaire (score 6 on question 19).

    20. Patients presenting predominant GERD (3 “yes” by GERD questionnaire).

    21. Patients not willing to take UV protective measures or patients at increased risk for phototoxicity (use of drugs like tetracyclins, amiodarone, sulphonamides, quinolones).
    E.5 End points
    E.5.1Primary end point(s)
    Time to maximal satiation or score maximally on one of the epigastric symptoms and drop in intragastric pressure during nutrient administration.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 3 and Visit 5
    E.5.2Secondary end point(s)
    Changes in dyspeptic symptoms as assessed by
    Dyspepsia Symptom Severity Scale (DSS), the Visceral Sensitivity Index
    (VSI), the Nepean Dyspepsia Index (NDI) and the PAGI-SYM
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 2, 3, 4 and 5
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.6Cross over Yes
    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 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
    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 months0
    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 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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state33
    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)
    normal standard medical care
    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 Decision2015-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-10-31
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