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    Summary
    EudraCT Number:2010-021397-12
    Sponsor's Protocol Code Number:M0003-C202
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-09-02
    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 number2010-021397-12
    A.3Full title of the trial
    An explorative, randomized, placebo-controlled, double-blind, parallel-group trial, to evaluate the pharmacodynamic effect of M0003 on reflux parameters in subjects with gastroesophageal reflux disease and with persistent symptoms despite taking a stable dose of proton pump inhibitors.
    A.4.1Sponsor's protocol code numberM0003-C202
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorShire-Movetis NV
    B.1.3.4CountryBelgium
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameM0003
    D.3.2Product code M0003
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 219984-49-3
    D.3.9.2Current sponsor codeM0003
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number to 0.5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Gastrointestinal esophageal reflux disease (GERD) refractory to proton pump inhibitor therapy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10017885
    E.1.2Term Gastrooesophageal reflux disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This is an exploratory trial :
    1. To measure the pharmacodynamic (PD) effect on parameters derived from 24-h pH/impedance (MII) monitoring,
    2. To explore the effect on symptoms,
    3. To evaluate the safety and tolerability

    of treatment with 0.5 mg M0003 (on top of PPI treatment), t.i.d. for 4 weeks, in subjects with GERD and with persistent symptoms despite taking a stable dose of proton pump inhibitors
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects who meet all of the following criteria are eligible for this trial:
    1. Written ICF signed voluntarily before the first trial-related activity.
    2. Aged between 18 and 70 years, extremes included.
    3. Subjects with a history of GERD symptoms (i.e., heartburn and/or regurgitation)
    during the last 6 months (as assessed by anamnesis/medical history).
    4. Subjects on a stable dose of PPIs, compliant for at least 6 weeks prior to screening.
    5. Subjects with heartburn and/or regurgitation, with at least one of these symptoms of moderate severity or worse, and at a minimum average frequency of three days a week during the two-week run-in period (determined by completion of a daily diary).
    6. A minimum of 25 liquid-containing reflux events over 24 h (pH/MII monitoring).
    7. BMI < 35.
    8. If the subject is a woman of childbearing potential, she
    a. must have a negative urine pregnancy test at screening and before the start of
    treatment (minimum β-Human Chorionic Gonadotropin [HCG] sensitivity of 25 mIU/ml), and
    b. must agree to either use an effective form of birth control (i.e., stabilized on oral
    contraceptives for at least 1 month or using implanted, transdermal or injected
    contraceptive hormones, an intra-uterine device, or continuous abstinence from
    heterosexual sexual contact), or a combination of a barrier method and a spermicidal agent (i.e., cervical cap and spermicidal agent, condom and spermicidal agent, or diaphragm and spermicidal agent), until 30 days after the end of treatment, or until the onset of menses (last day of menses to be documented at screening, baseline visit and visit 6).
    9. Endoscopy within the last 5 years prior to randomisation, negative for grade C & D
    oesophagitis.
    E.4Principal exclusion criteria
    Subjects meeting one or more of the following criteria cannot be selected:
    1. History of cardiac arrhythmias, uncontrolled bronchospastic disease, cardiovascular
    disease (e.g., ischemic heart disease or cerebrovascular accident), thyrotoxicosis.
    2. Subjects with a family history of sudden death or a congenital QT syndrome.
    3. Presence of prolonged QTc (Bazett and Fridericia) on ECG at screening (QTc ≥ 450
    msec for males and QTc ≥ 470 msec for females).
    4. Subjects with a documented history of long segment (>3 cm) Barrett’s oesophagus.
    5. Subjects with documented or suspected large (> 3 cm) hiatus hernia.
    6. Subjects with fundoplication, endoscopic anti-reflux procedure or major prior GI
    surgery.
    7. Subjects with clinically significant abnormalities as judged by the investigator at
    screening physical examination, or in blood haematology and biochemistry tests
    performed at screening.
    8. Subjects with a structural abnormality or structural disease condition of the GI tract.
    9. Severe oesophageal motility disorders (e.g., scleroderma, achalasia, nutcracker
    oesophagus).
    10. Subjects who suffer from frequent vomiting (>1/week, as assessed during
    anamnesis).
    11. Current diagnosis of co-existing psychiatric disease (including alcohol or drug
    abuse); controlled depression and anxiety are allowed, when treated with at most
    one drug, at a stable dose.
    12. Subjects suffering from severe and/or uncontrolled endocrine (e.g., insulindependent diabetes mellitus, hypopituitarism, hypothyroidism, hypercalcaemia,
    pseudohypopara-thyroidism), metabolic (e.g., porphyria, hypokalaemia, amyloidal
    neuropathy) and neurologic diseases (e.g., Parkinson’s disease, multiple sclerosis,
    meningocele, aganglionosis, hypoganglionosis, hyperganglionosis, autonomic neuropathy, spinal cord injury, Chagas’ disease, major depression). Endocrine and
    metabolic disorders controlled by appropriate medical therapy will not be excluded,
    except for insulin-dependent diabetes mellitus.
    13. Presence of severe and clinically uncontrolled cardiovascular, liver or lung disease,
    neurologic, cancer or AIDS.
    14. Alarm symptoms suggestive of malignancies or organic disease such as: obstructive dysphagia, odynophagia, GI bleeding, blood in stool or anaemia, weight loss; unless investigated and found to be negative.
    15. Impaired renal function, i.e., serum creatinine concentration >2 mg/dl (>180 μmol/l).
    16. Use of prohibited co-medication less than 7 days before the start of the 2-week runin period (baseline symptom assessment).
    17. Any condition that, in the opinion of the Investigator(s), would complicate or
    compromise the trial (e.g., human immunodeficiency virus [HIV] infection,
    gastroduodenal ulcer) or the well-being of the subject, or evidence of any clinically
    relevant pathology that could interfere with trial results or put subject safety at risk.
    18. Participation in an investigational drug trial in 30 days prior to enrolment.
    19. Breast-feeding subjects.
    E.5 End points
    E.5.1Primary end point(s)
    This is an exploratory trial.

    • the number of liquid-containing reflux events per 24-h period;
    • the average proximal extent of all liquid-containing reflux events in the 24-h period;
    • average bolus clearance times of all liquid-containing reflux events in the 24-h
    period;
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    tolerability
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    placebo controlled
    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.8.3 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 concerned3
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The last visit of the last subject
    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 months1
    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 months1
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 100
    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 Decision2010-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-05-29
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