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    Summary
    EudraCT Number:2019-002185-13
    Sponsor's Protocol Code Number:clebopride2019
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-08-02
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2019-002185-13
    A.3Full title of the trial
    A Randomized, Double Blind, Placebo Controlled, Crossover Trial of Clebopride vs Placebo in the Treatment of Clinically Suspected Rumination.
    Een gerandomiseerde, dubbel-blinde, placebo-gecontroleerde, crossover studie naar het effect van clebopride op symptomen van terugvloei en boeren
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Double Blind, Placebo Controlled, Crossover Trial of Clebopride vs Placebo in the Treatment of Clinically Suspected Rumination.
    Een gerandomiseerde, dubbel-blinde, placebo-gecontroleerde, crossover studie naar het effect van clebopride op symptomen van terugvloei en boeren
    A.4.1Sponsor's protocol code numberclebopride2019
    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 SponsorKU Leuven - TARGID
    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 supportTARGID
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKU Leuven - TARGID
    B.5.2Functional name of contact pointAns Pauwels
    B.5.3 Address:
    B.5.3.1Street AddressHerestraat 49 - box 701
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.4Telephone number3216343385
    B.5.6E-mailans.pauwels@kuleuven.be
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Cleboril
    D.2.1.1.2Name of the Marketing Authorisation holderAlmirall
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 INNCLEBOPRIDE
    D.3.9.1CAS number 55905-53-8
    D.3.9.4EV Substance CodeSUB06646MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    rumination syndrome
    ruminatie
    E.1.1.1Medical condition in easily understood language
    rumination syndrome
    ruminatie
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    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
    To assess the efficacy of clebopride 0.5 mg t.i.d. on the perceived overall treatment evaluation (by means of a Likert scoring system)
    E.2.2Secondary objectives of the trial
    To assess the effect of clebopride on the number of symptom events, indicated by the patient, during high-resolution impedance manometry, the number of flow event identified on High Resolution impedance Manometry (HRiM), lower esophageal sphincter (LES) pressure, the number of transient LES relaxations (TLESRs) and on intra-gastric pressure
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Minimum 18 years old.
    2. History assessed by a gastroenterologist consistent with probable rumination syndrome.
    3. Have completed a gastro-duodenoscopy, within 12 months, showing no anatomical abnormality of the stomach or esophagus, which can explain the patients’ symptoms.
    4. Patients will have to have tried the equivalent of 20mg of daily omeprazole for 2 weeks prior to consideration of inclusion in the study.
    5. Sexually active women of child bearing potential participating in the study must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception.
    6. Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed.
    E.4Principal exclusion criteria
    1. Endoscopic signs of severe erosive esophagitis (≥ grade B, Los Angeles classification) on endoscopy performed during PPI treatment in the 12 months prior to screening.
    2. Systemic diseases, known to affect esophageal motility.
    3. Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed).
    4. QT c>450 ms.
    5. Parkinson’s syndrome or related syndromes.
    6. History of adverse drug reactions (pseudo-Parkinsonism, tardive dyskinesia, restless legs) upon exposure to dopaminergic drugs.
    7. Concomitant use of medications such as anticholinergics, tricycle antidepressants, baclofen, dopamine antagonists or dopaminergic drugs and prokinetics.
    8. Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator.
    9. Major psychiatric disorder – as determined by the clinicians.
    10. Pregnancy or breast-feeding.
    11. History of poor compliance.
    12. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.
    13. History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.
    E.5 End points
    E.5.1Primary end point(s)
    • Difference in overall treatment evaluation (OTE) between clebopride and placebo in the treatment of rumination syndrome
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 2 weeks of treatment
    E.5.2Secondary end point(s)
    • Difference in overall symptom severity (OSS) between treatment with clebopride and placebo
    • Difference in number of symptom events, as indicated by the patients during HRiM, between treatment with clebopride and placebo
    • Difference in number of flow events during HRiM between treatment with clebopride and placebo
    o Gastro-oesophageal reflux
    o Rumination:
     Primary Rumination
     Secondary Rumination
     Supra-gastric belch associated rumination
    o Supra-gastric belching
    o Gastric belching
    • Difference in esophago-gastric junction (EGJ) pressure (mmHg) during HRiM between treatment with clebopride and placebo
    • Difference in number of TLESRs during HRiM between both treatment periods
    • Difference in intragastric pressure (mmHg) during HRiM between both treatment periods
    • Difference in number of events with increased intra-gastric pressure during HRiM between both treatment periods
    • Difference in number of symptoms as assessed by a daily symptom diary (Leuven Postprandial Distress Scale) between both treatment periods
    • Difference in symptom severity assessed at the end of each treatment period between both treatment periods
    • Difference in quality of Life assessed at the end of each treatment period between both treatment periods
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 2 weeks of treatment
    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 No
    E.6.5Efficacy No
    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 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 years
    E.8.9.1In the Member State concerned months24
    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: 15
    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 state20
    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)
    None
    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 Decision2019-08-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-03
    P. End of Trial
    P.End of Trial StatusOngoing
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