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    Summary
    EudraCT Number:2015-002969-27
    Sponsor's Protocol Code Number:PMF104PD1-2-3/2013
    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:2017-04-11
    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 number2015-002969-27
    A.3Full title of the trial
    A RANDOMISED, SINGLE-BLIND, ACTIVE CONTROLLED, MULTI-CENTRE TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, ACCEPTABILITY AND PALATABILITY OF PMF104 COMPARED TO A CONVENTIONAL PEG-ELECTROLYTE SOLUTION IN CHILDREN AGED FROM 2 TO LESS THAN 6, FROM 6 TO LESS THAN 12 AND ADOLESCENTS FROM 12 TO LESS THAN 18 YEARS OF AGE REQUIRING A DIAGNOSTIC PROCEDURE CONCERNING THE COLON
    (EMA Decision P/019/2017 on the acceptance of modification of Paediatric Investigation Plan)
    Een gerandomiseerd, enkelblind, actief gecontroleerd, multicentrisch onderzoek ter evaluatie van de doeltreffendheid, veiligheid, verdraagbaarheid, aanvaardbaarheid en smakelijkheid van PMF104 in vergelijking met een conventionele PEG-elektrolytenoplossing bij kinderen van 2 tot 6 jaar, van 6 tot 12 jaar en adolescenten van 12 tot 18 jaar die een diagnostische procedure inzake de dikke darm vereisen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial aimed at evaluating the efficacy, safety, tolerability, acceptability and palatability of PMF104 in children from 2 to less than 18 years old
    A.4.1Sponsor's protocol code numberPMF104PD1-2-3/2013
    A.5.4Other Identifiers
    Name:CRO-15-125Number:CRO code
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/223/2018
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAlfasigma S.p.A.
    B.1.3.4CountryItaly
    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 supportAlfasigma S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAML Clinical Services BVBA
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressTempelzicht 8
    B.5.3.2Town/ cityLinden
    B.5.3.3Post codeB-3210
    B.5.3.4CountryBelgium
    B.5.4Telephone number+32(0)16782170
    B.5.5Fax number+32(0)16788672
    B.5.6E-mailC125-AML@aml-research.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 Yes
    D.2.1.1.1Trade name Clensia®
    D.2.1.1.2Name of the Marketing Authorisation holderAlfasigma S.p.A. (Italy)
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Powder for oral solution in sachet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    Nasogastric use (Noncurrent)
    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 PH. EUR.
    D.3.9.4EV Substance CodeSUB172298
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number52.500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium sulfate, anhydrous
    D.3.9.1CAS number 7757-82-6
    D.3.9.3Other descriptive nameSODIUM SULPHATE
    D.3.9.4EV Substance CodeSUB20969
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.750
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSimeticone
    D.3.9.1CAS number 8050-81-5
    D.3.9.3Other descriptive nameSIMETICONE
    D.3.9.4EV Substance CodeSUB04403MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.080
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium citrate
    D.3.9.1CAS number 68-04-2
    D.3.9.3Other descriptive nameSODIUM CITRATE
    D.3.9.4EV Substance CodeSUB34328
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.863
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCitric acid anhydrous
    D.3.9.1CAS number 77-92-9
    D.3.9.3Other descriptive nameCITRIC ACID ANHYDROUS
    D.3.9.4EV Substance CodeSUB29050
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.813
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium chloride
    D.3.9.1CAS number 7647-14-5
    D.3.9.3Other descriptive nameSODIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12581MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.730
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPotassium chloride
    D.3.9.1CAS number 7447-40-7
    D.3.9.3Other descriptive namePOTASSIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12559MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.370
    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.IMP: 2
    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 KLEAN-PREP
    D.2.1.1.2Name of the Marketing Authorisation holderNorgine Italia S.r.l.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameKLEAN-PREP
    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
    Nasogastric use (Noncurrent)
    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
    Need of bowel cleansing in order to perform a colonoscopy or any other diagnostic or therapeutic procedure concerning the colon.
    E.1.1.1Medical condition in easily understood language
    Bowel cleansing before diagnostic or therapeutic procedures concerning colon.
    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 10066943
    E.1.2Term Bowel preparation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    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 efficacy of PMF104 compared to KLEAN-PREP in children aged from 2 to less than 18 years old requiring a diagnostic procedure of the colon
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy, safety, tolerability, acceptability and palatability of PMF104 compared to KLEAN-PREP in children aged from 2 to less than 18 years old requiring a diagnostic procedure of the colon
    Het evalueren van de doeltreffendheid, veiligheid, verdraagbaarheid, aanvaardbaarheid en smakelijkheid van PMF104 bij pediatrische proefpersonen die een diagnostische procedure van de dikke darm nodig hebben
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female patients aged from 2 to less than 18 years undergoing elective colonoscopy
    2. Female subjects currently either of:
    non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is surgically sterilised via documented hysterectomy or bilateral tubal ligation),
    or
    child bearing potential: the subject is eligible to enter and participate in this study if she is not lactating and has a negative pregnancy test (only menstruated females) and agrees to abstain from intercourses until the colonoscopy is performed
    3. Patients whose parents/legal representatives have been thoroughly informed of the aim of the study procedures and provided signed and dated written informed consent
    4. Children aged from 6 to less than 12 years providing informed assent whenever possible
    5. Adolescents aged from 12 to less than 18 years providing informed assent
    6. Ability of the subjects and/or their parents/legal representatives to understand and comply with protocol requirements, instructions and protocol-stated restrictions
    1. Mannelijke en vrouwelijke patiënten van 2 tot 18 jaar oud tijdens de hele onderzoeksperiode en die electieve colonoscopie ondergaan
    2. Vrouwelijke proefpersonen die momenteel ofwel:
    niet vruchtbaar zijn (d.w.z. fysiologisch niet in staat zwanger te worden, waaronder alle vrouwen die chirurgisch gesteriliseerd werden via gedocumenteerde hysterectomie of bilaterale tubaligatie),
    of
    die vruchtbaar zijn: de proefpersoon komt in aanmerking om zich in dit onderzoek in te schrijven en eraan deel te nemen als zij geen borstvoeding geeft en een negatieve zwangerschapstest heeft (enkel vrouwen met menstruatie), en stemt ermee in zich te onthouden van geslachtsgemeenschap tot na de colonoscopie is uitgevoerd
    3. Patiënten wiens ouders/wettelijke vertegenwoordigers grondig geïnformeerd werden over het doel van de onderzoeksprocedures en die een ondertekende en gedateerde schriftelijke geïnformeerde toestemming hebben gegeven
    4. Kinderen van 6 tot 12 jaar die waar mogelijk geïnformeerde instemming hebben gegeven
    5. Kinderen van 12 tot 18 jaar die geïnformeerde instemming hebben gegeven
    6. Vermogen van de proefpersonen/of hun ouders/wettelijke vertegenwoordigers om de vereisten van het protocol, de instructies en de protocol-gerelateerde beperkingen te begrijpen en na te leven.
    E.4Principal exclusion criteria
    1. Requirement for urgent colonoscopy
    2. Gastrointestinal obstruction or perforation
    3. Bowel pseudo-obstruction
    4. Gastric retention
    5. Toxic colitis
    6. Toxic megacolon
    7. Known or suspected hypersensitivity to the active or other ingredients of both test product and reference product
    8. Clinically significant electrolyte imbalance
    9. Prior intestinal resection
    10. Structural abnormality of the lower gastrointestinal (GI) tract
    11. Known metabolic (particularly phenylketonuria), hepatic, renal or cardiac disease
    12. Congestive heart failure (NYHA class III and IV)
    13. Known pregnancy
    14. Subject who have participated in another clinical trial or have taken an investigational drug within the last 3 months prior screening
    1. Vereiste voor dringende colonoscopie
    2. Gastro-intestinale blokkering of perforatie
    3. Pseudo-obstructie van de darmen
    4. Gastrische retentie
    5. Toxische colitis
    6. Toxische megacolon
    7. Gekende of vermeende overgevoeligheid voor de actieve of andere bestanddelen van zowel het test- als referentieproduct
    8. Klinisch significante ontregeling van de elektrolytbalans
    9. Eerdere intestinale resectie
    10. Structurele afwijking van het onderste gastro-intestinale (GI) kanaal
    11. Gekende metabolische (in het bijzonder fenylketonurie), lever-, nier- of hartziekte
    12. Congestief hartfalen (NYHA klasse III en IV)
    13. Gekende zwangerschap
    14. De proefpersoon heeft deelgenomen aan een ander klinisch onderzoek of heeft in de 3 maanden voorafgaand aan de screening een onderzoeksgeneesmiddel ingenomen.
    E.5 End points
    E.5.1Primary end point(s)
    To compare the efficacy in terms of colon cleansing according the Boston Bowel Preparation Scale (BBPS) score on the day of the diagnostic procedure, to be determinated blindly by the endoscopist upon completion of the examination
    E.5.1.1Timepoint(s) of evaluation of this end point
    Upon completion of the examination (Visit 3, Day 2)
    E.5.2Secondary end point(s)
    1. Efficacy:
    - Time to reach clear watery stools
    - Proportion of patients in whom caecal intubation was achieved during colonoscopy
    - Proportion of patients achieving a BBPS score grater than or equal to 5
    2. Proportion of patients that needed a rescue dose
    3. Safety assessment
    4. Tolerability assessment
    5. Compliance assessment
    6. Acceptability assessment
    7. Palatability assessment
    1. Doeltreffendheid:
    - Tijd tot het bereiken van heldere waterige stoelgang
    - Aandeel patiënten bij wie intubatie van de blinde darm bereikt werd tijdens de colonoscopie
    - Aandeel patiënten die een BBPS-score ≥ 5 behalen
    2. Aandeel patiënten die een dosis reddingsmedicatie nodig hebben
    3. Beoordelingen voor veiligheid
    4. Beoordelingen voor verdraagbaarheid
    5. Beoordelingen voor naleving
    6. Beoordelingen voor aanvaardbaarheid
    7. Beoordelingen voor smakelijkheid
    E.5.2.1Timepoint(s) of evaluation of this end point
    During /after the 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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability, acceptability and palatability
    Verdraagbaarheid, aanvaardbaarheid en smakelijkheid
    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 Yes
    E.8.1.4Double blind No
    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 No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Last Visit Last Subject
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    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 Yes
    F.1.1Number of subjects for this age range: 396
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 228
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 168
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 2017-04-11. Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Preschool minors
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 396
    F.4.2.2In the whole clinical trial 396
    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 Decision2017-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-21
    P. End of Trial
    P.End of Trial StatusOngoing
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