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    Summary
    EudraCT Number:2018-001914-13
    Sponsor's Protocol Code Number:MACR001
    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:2018-08-01
    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 number2018-001914-13
    A.3Full title of the trial
    Clinical Trial to Evaluate the Efficacy and Safety of MACRORANGE® in Patients Suffering from Functional Constipation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Trial to Evaluate the Efficacy and Safety of MACRORANGE® in Patients Suffering from Constipation
    A.4.1Sponsor's protocol code numberMACR001
    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 SponsorSalsarulo Pharma
    B.1.3.4CountryFrance
    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 supportSalsarulo Pharma
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAepodia SA
    B.5.2Functional name of contact pointFrédéric Segaud
    B.5.3 Address:
    B.5.3.1Street AddressRue Louis de Geer, 6
    B.5.3.2Town/ cityLouvain-la-Neuve
    B.5.3.3Post codeB-1348
    B.5.3.4CountryBelgium
    B.5.4Telephone number+32(0)10 39 20 11
    B.5.6E-mailregulatory@aepodia.com
    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 nameMacrorange
    D.3.4Pharmaceutical form Oral paste in sachet
    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 INNMACROGOL 4000
    D.3.9.1CAS number 25322-68-3
    D.3.9.3Other descriptive nameMACROGOL 4000
    D.3.9.4EV Substance CodeSUB20831
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number14,4
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Functional constipation
    E.1.1.1Medical condition in easily understood language
    Constipation with stool frequency < 3 per week
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10010774
    E.1.2Term Constipation
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    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 MACRORANGE® in patients with functional constipation (according to Rome III criteria) after daily administration of MACRORANGE® up to 14 days.
    E.2.2Secondary objectives of the trial
    To describe the average daily dosage of MACRORANGE® from Day 3 up to End of Study.
    To further evaluate the tolerance of MACRORANGE® in patients with functional constipation.
    To evaluate the taste of MACRORANGE®.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age of the patients: ≥ 18 years of age;
    • Male and female patients;
    • Stool frequency < 3 per week;
    • Functional constipation as defined in constipation module of ROME III
    E.4Principal exclusion criteria
    • Irritable Bowel Syndrome (IBS specifically type C);
    • Hypersensitivity to the active substances or any excipients;
    • Organic inflammatory bowel disease (ulcerative rectocolitis, Crohn’s disease);
    • Toxic megacolon;
    • Gastrointestinal obstruction or subocclusive syndromes;
    • Allergic to aspartame;
    • Painful abdominal syndromes of undetermined origin;
    • Existing partial colectomy or bariatric surgery (gastric bypass type);
    • Presumed non-cooperativeness;
    • Concomitant treatment from start of wash-out period until discharge from the study with any medication that may alter the gastrointestinal motility (see section 6.2.2) in the opinion of the Investigator;
    • Legal incapacity;
    • Any clinical condition which does not justify study participation in the Investigator's opinion;
    • Participation ≤ 8 weeks in a clinical trial;
    • Parallel participation in a clinical trial;
    • Repeated participation in this clinical trial.
    E.5 End points
    E.5.1Primary end point(s)
    After a washout of one week, the primary endpoint will be:
    • The average number of complete spontaneous defecations per week for a 2 weeks period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Everyday during the 2-weeks treatment period (via a patient diary)
    E.5.2Secondary end point(s)
    Complete spontaneous defecations:
    • Change from baseline of the average number of complete spontaneous defecations per week for a 2 weeks period;
    • Average number of complete spontaneous defecations per week from Day 1 up to Day 7;
    • Average number of complete spontaneous defecations per week from Day 8 up to End of study.

    Other endpoints:
    • Average of daily dosage of MACRORANGE® from Day 3 up to End of study;
    • Results of the constipation symptoms;
    • Results of the Clinical Global Impression (CGI, independent rater) as provided in Appendix 3;
    • Results of the Global assessment of efficacy (patient) in Appendix 3;
    • Assessment of safety parameters: adverse events, laboratory test results, ordinal scales regarding tolerability;
    • Taste of MACRORANGE®.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Everyday during the 2-weeks treatment period (via a patient diary) and/or during the study visits scheduled at Day 1, Day 8 and Day 15.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    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 months6
    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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2018-08-01. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state30
    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 Decision2018-08-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-26
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